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Erlotinib

  • Prescription medicine
  • Prescription only
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Erlotinib does in the body

The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen.

From the FDA-approved label: Epidermal growth factor receptor (EGFR) is expressed on the cell surface of both normal and cancer cells. In some tumor cells signaling through this receptor plays a role in tumor cell survival and proliferation irrespective of EGFR mutation status. Erlotinib reversibly inhibits the kinase activity of EGFR, preventing autophosphorylation of tyrosine residues associated with the receptor and thereby inhibiting further downstream signaling. Erlotinib binding affinity for EGFR exon 19 deletion or exon 21 (L858R) mutations is higher than its affinity for the wild type receptor. Erlotinib inhibition of other tyrosine kinase receptors has not been fully characterized.

Why people take it. The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen.

What happened in people

RNAWiki has not yet published a reviewed conclusion for this use.

A fixed RNAWiki sentence

Where this came from

Wording RNAWiki always uses, not a finding about this substance.

No reviewed claim names a result for any goal on this record.

No source is stored against this line.

The limit that matters most

Not recorded.

Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

What the registries record it as

  • The substance registry classes this as chemical.

    FDA substance registry · J4T82NDH7E · read 2026-08-29

  • Its recorded molecular formula is C22H23N3O4·HCl, weighing 429.90.

    US prescribing information · a3b2d622-b4d5-4819-862b-f8fd3adcec6f · read 2026-08-30

Where each sentence above came from

The use the label states, quoted from it. No plain-language version of this sentence has been written.

The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.

No statement of the main limit is recorded.

The four opening statements run to 216 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Biomarker

A biomarker is a number from a test that stands in for something about health.

A picture of it, and where the picture fails

A biomarker is like a fuel gauge.

Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.

What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.

A measurable indicator used as a substitute for a clinical outcome of interest.

Placebo

A placebo is a dummy treatment given so the real one can be compared with it.

A picture of it, and where the picture fails

A placebo is like a blank control in an experiment.

Where that stops being true. A blank does nothing. People given a placebo often do get better.

What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.

An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.

Comparator

A comparator is whatever the treatment was measured against.

A picture of it, and where the picture fails

It is like the other runner in a race.

Where that stops being true. A race has one winner. A study can show both arms improved.

What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.

The control condition against which the experimental intervention is assessed.

What happened in peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

Central and local clinical genotyping to facilitate accrual to the adjuvant Intergroup studies, E4512 and A081105

The study did not show it

Who was studied
NCT02194738
How many people
8300
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST)

The study did not show it

Who was studied
NCT00949910
How many people
6586
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Progression-free survival (PFS)

The study did not show it

Who was studied
NCT04322890
How many people
6000
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

A Study to Evaluate Tarceva in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

The study did not show it

Who was studied
NCT00091663
How many people
5000
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Time to Disease Progression or Death by Line of Treatment

The study did not show it

Who was studied
NCT01996332
How many people
1805
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Progression-Free Survival (PFS) in the Overall Population

The study did not show it

Who was studied
NCT00312377
How many people
1690
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • Erlotinib tablets are a kinase inhibitor indicated for: • The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy…

Who is missing from the studies

  • Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What the label states about particular groups

  • On pediatric, the label states: “The safety and effectiveness of erlotinib in pediatric patients have not been established.”

    US prescribing information · a3b2d622-b4d5-4819-862b-f8fd3adcec6f · read 2026-08-30

  • On older people, the label states: “Of the 1297 subjects in clinical studies of erlotinib for the treatment of NSCLC and pancreatic cancer 40% were 65 and older while 10% were 75 and older.”

    US prescribing information · a3b2d622-b4d5-4819-862b-f8fd3adcec6f · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Based on animal data and its mechanism of action, erlotinib can cause fetal harm when administered to a pregnant woman.”

    US prescribing information · a3b2d622-b4d5-4819-862b-f8fd3adcec6f · read 2026-08-30

  • On people who are breastfeeding, the label states: “8.3 Females and Males of Reproductive Potential Contraception Females Erlotinib can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ].”

    US prescribing information · a3b2d622-b4d5-4819-862b-f8fd3adcec6f · read 2026-08-30

  • On people with reduced liver function, the label states: “Hepatic failure and hepatorenal syndrome, including fatal cases, can occur with erlotinib treatment in patients with normal hepatic function; the risk of hepatic toxicity is increased in patients with baseline hepatic impairment [see Warnings and Precautions (5.3) , Adverse Reactions (6.1 , 6.2) , and Dosage and Administration].”

    US prescribing information · a3b2d622-b4d5-4819-862b-f8fd3adcec6f · read 2026-08-30

Where the result stopped carrying

  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

What it would be like to takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied in different people

The people in the studies were not much like the reader.

On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

The evidence may simply be wrong

Small early studies often do not hold up.

On this record: RNAWiki has not yet published a reviewed conclusion for this use.

Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Prescription only

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Read from the recorded approval status.

No source is stored against this line.

Form and route

Oral

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Suppression classes recorded: S1, S3, S4.

No source is stored against this line.

What is in the pack

Sold as tablet, tablet, film coated, given by the oral route.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on how this is sold and what that means for what is in the pack.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

Register entries are stored per jurisdiction and shown with their dates.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

What it would be like to takeNothing found in the sources checked

What can go wrong

Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.

Nothing found in the sources checked

No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.

The sources listed were searched and held nothing. That is not the same as nothing existing.

Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.

Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Oral

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing further is recorded about which forms are sold.

No source is stored against this line.

What is recorded as being sold

  • 46 products list this as an active ingredient in the United States drug directory. 46 of them contain it and nothing else.

    FDA National Drug Code directory · 72205-082 · read 2026-08-29

  • They are sold as powder, powder, for suspension, tablet and tablet, film coated, taken oral.

    FDA National Drug Code directory · 72205-082 · read 2026-08-29

  • The regulator's established pharmacologic class for it is kinase inhibitor [epc] and protein kinase inhibitors [moa].

    FDA National Drug Code directory · 72205-082 · read 2026-08-29

  • 12 published labels name it as an active ingredient. 12 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · a3b2d622-b4d5-4819-862b-f8fd3adcec6f · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · a3b2d622-b4d5-4819-862b-f8fd3adcec6f · read 2026-08-29

  • ERLOTINIB is oral at 3 DOSAGE FORMS AND STRENGTHS 25 mg tablets White colored, round biconvex film-coated tablets debossed with “H” on one side and “28” on the other side. 100 mg tablets White colored, round biconvex film-coated tablets deb…, recorded as fda label in effect 2024-06-26 in the United States.

    US prescribing information · a3b2d622-b4d5-4819-862b-f8fd3adcec6f · read 2026-08-30

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

What it would be like to takeRead from sources, not yet reviewed

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Erlotinib studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

Tracking can show whether something changed for you. It cannot show what caused it.

RNAWiki records evidence. It does not say whether this substance is right for you.

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

Missing populations

Which groups were under-represented in the studies has not been recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing long-term data

No completed tested study window is recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

No reviewed conclusion

RNAWiki has not yet published a reviewed conclusion for this use.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing interaction studies

No interaction was found in the registers checked. Not finding one is not the same as showing there is none.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Formulation uncertainty

Several salts, forms or products of Erlotinib are recorded. Results from one form may not transfer to another.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

How many documents were read

  • 11 documents were read for this substance.

    RNAWiki source record

  • 11 of them state the same halfLife, and they agree.

    RNAWiki source record

  • 11 of them state the same bioavailability, and they agree.

    RNAWiki source record

  • 11 of them state the same volumeOfDistribution, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
J4T82NDH7E
CAS registry number
183321-74-6
PubChem compound
176870
ChEMBL
CHEMBL553
ChEBI
53509
WHO international nonproprietary name list entry
8133
RxNorm concept
337525
EMA substance identifier
100000089519
DrugBank
DB00530

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Quoted from a stored source.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S1, S3, S4.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

  • 14 approved applications cover products containing this substance. The earliest was NDA021743, approved 20041118 to OSI PHARMS.

    Drugs@FDA application register · NDA021743 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA021743 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20041108.

    FDA National Drug Code directory · 72205-082 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

9 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

  • What was measured, goal by goal — found nothing in the sources checked.
  • How close this is to real life — found nothing in the sources checked.
  • The path through the body — found nothing in the sources checked.
  • Felt, measured, or meaningful — found nothing in the sources checked.
  • How long anything takes — found nothing in the sources checked.
  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • Claims that go past the evidence — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

The record as stored

The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

Recorded evidence blocks (11)

On the Erlotinib label: indicated for what?

"Erlotinib tablets are a kinase inhibitor indicated for: • The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line,…": indications and usage on Erlotinib's label. DailyMed label · a3b2d622-b4d5-4819-862b-f8fd3adcec6f · 2024-06-26

655 registered trials of Erlotinib — at which phases?

Registered studies posting no result
349 of 655

655 registered studies of Erlotinib: 413 phase2, 199 phase1, 73 phase3, 15 na or unstated, 13 na, 13 phase4, 3 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01

886 with a PubMed record

Show the evidence
  • phase2
    413
  • phase1
    199
  • phase3
    73
  • na or unstated
    15
  • na
    13
  • phase4
    13
10 more recorded rows
  • early phase1
    3
  • completed
    435
  • terminated
    106
  • unknown
    67
  • withdrawn
    21
  • active not recruiting
    13
  • recruiting
    8
  • not yet recruiting
    3
  • suspended
    1
  • temporarily not available
    1

recorded 2026-09-01 · last checked 2026-09-04

109 of Erlotinib's trials stopped: safety, futility/efficacy, accrual/recruitment, funding/business, sponsor decision unspecified, other?

safety (16), futility/efficacy (6), accrual/recruitment (49), funding/business (10), sponsor decision unspecified (6) and other (22): Erlotinib's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Administratively complete."; 109 of 655 registered studies

Show the evidence

Trial

  • NCT00042835
    terminated; "Administratively complete."
  • NCT00047333
    terminated; "Administratively complete."
  • NCT00063258
    terminated; "Low accrual rate"
  • NCT00227032
    terminated; "Loss of funding"
  • NCT00251589
    terminated; "This trial is being closed based on lack of substantive efficacy, slow accrual and overall tolerance in patients treated to date."
  • NCT00276744
    terminated; "Because there was no longer an active laboratory component to this study."
14 further recorded trials
  • NCT00281021
    terminated; "Interim analysis revealed that only 1 patient had a partial response."
  • NCT00336700
    terminated; "Study published November 2010 and no further work will be done"
  • NCT00351039
    terminated; "slow accrual"
  • NCT00385398
    withdrawn; "lack of funding and drug supply"
  • NCT00387894
    terminated; "Insufficient accrual of population likely to benefit; progression in 6 patients"
  • NCT00391586
    terminated; "PI left institution."
  • NCT00392665
    terminated; "slow accrual"
  • NCT00412217
    terminated; "The study was terminated because recruitment was too slow."
  • NCT00428194
    withdrawn; "Withdrawn due to lack of accrual"
  • NCT00442507
    terminated; "Slow accrual"
  • NCT00448240
    terminated; "Low Accrual, Funding"
  • NCT00452075
    terminated; "Poor recruitment"
  • NCT00470535
    terminated; "This study was terminated earlier due to a phase III study that showed this drug inferior to sorafenib"
  • NCT00482625
    terminated; "The protocol has been completed prematurely (e.g., due to poor accrual, insufficient drug supply, IND closure)."

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Erlotinib used Erlotinib 150 mg — over how long?

studies of Erlotinib used the recorded amount. ClinicalTrials.gov · 2026-09-01

5 recorded entries; human; also "Erlotinib 150 mg", "Erlotinib 150mg", "Tarceva 100Mg Tablet"

Show the evidence

human

  • NCT01836133
    Erlotinib 150 mg
  • NCT02006043
    Erlotinib 150mg
  • NCT03086538
    Tarceva 100Mg Tablet
  • NCT04145570
    Erlotinib HCl 150 mg
  • NCT05442060
    Erlotinib (150 mg daily)

recorded 2026-09-01 · last checked 2026-09-04

Erlotinib's half-life is 36.2 hours — which schedules were studied?

36.2 hours, the half-life Erlotinib's label states: "Elimination Erlotinib is eliminated with a median half-life of 36.2 hours in patients receiving the single-agent erlotinib 2 nd /3 rd line regimen." DailyMed label · a3b2d622-b4d5-4819-862b-f8fd3adcec6f · 2024-06-26

bioavailability 100 %.

Show the evidence
  • half life pharmacokinetics
    36.2 hours; Elimination Erlotinib is eliminated with a median half-life of 36.2 hours in patients receiving the single-agent erlotinib 2 nd /3 rd line regimen.
  • bioavailability pharmacokinetics
    100 %; Effect of Food Food increased the bioavailability of erlotinib to approximately 100%.
  • metabolism pharmacokinetics
    Metabolism Erlotinib is metabolized primarily by CYP3A4 and to a lesser extent by CYP1A2, and the extrahepatic isoform CYP1A1, in vitro .

recorded 2024-06-26 · last checked 2026-09-04

Which running trial of Erlotinib could settle lifespan?

NCT05442060 measures Progression-free survival rated at one year, reading out 2026-05-31.

8 open trials; n 60; "To Evaluate OBI-833/OBI-821 in Combination With First-Line Erlotinib in Patients With EGFR-Mutated, Globo H-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer"

Show the evidence

Trial

  • NCT05442060
    "To Evaluate OBI-833/OBI-821 in Combination With First-Line Erlotinib in Patients With EGFR-Mutated, Globo H-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer"; n 60; "Progression-free survival rated at one year"; 2026-05-31
  • NCT02152631
    "A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer"; n 453; "Overall Survival (OS)"; 2026-12
  • NCT02411448
    "A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)"; n 545; "Part B: Progression Free Survival (PFS)"; 2026-12
  • NCT02193282
    "Erlotinib Hydrochloride in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Completely Removed by Surgery (An ALCHEMIST Treatment Trial)"; n 390; "Overall survival (OS)"; 2027-02-03
  • NCT01708954
    "Erlotinib Hydrochloride and Cabozantinib-s-Malate Alone or in Combination as Second or Third Line Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer"; n 125; "Progression-free Survival (PFS)"; 2027-03-31
  • NCT00977470
    "Erlotinib With or Without Hydroxychloroquine in Chemo-Naive Advanced NSCLC and (EGFR) Mutations"; n 76; "Median Progression Free Survival"; 2027-12
2 further recorded trials
  • NCT03137771
    "Maintenance Chemotherapy With or Without Local Consolidative Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer"; n 218; "[Phase II] Progression-free Survival"; 2028-12
  • NCT00602667
    "Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma"; n 293; "Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients"; 2029-04

Which 170 trials of Erlotinib posted no result?

Posted no result
170 of 170 completed trials
Registrations
NCT00109265, NCT00030537, NCT00047736, NCT00040183, NCT00036647 and NCT00033241, and 164 more
Completion dates
oldest 2002-10; newest 2024-05-21
Show the evidence

Trial

  • NCT00109265
    2002-10
  • NCT00030537
    2003-03
  • NCT00047736
    2003-07
  • NCT00040183
    2004-01-15
  • NCT00036647
    2004-01-30
  • NCT00033241
    2004-04-22
14 further recorded trials
  • NCT00049101
    2004-08
  • NCT00081614
    2005-07
  • NCT00091663
    2005-08
  • NCT00337883
    2005-10
  • NCT00072072
    2006-01
  • NCT00032123
    2006-05
  • NCT00043823
    2006-05-15
  • NCT00088946
    2006-07
  • NCT00123851
    2006-08
  • NCT00095225
    2006-11
  • NCT00144976
    2006-12
  • NCT00200395
    2007-01-12
  • NCT00137800
    2007-03
  • NCT00281866
    2007-03

At the median, Erlotinib's trials enrolled 50 people — anything larger?

Median enrolment
50
Largest enrolment
8300
Registered trials counted
643

What do 4950 spontaneous reports say about Erlotinib — and not say?

These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.

Erlotinib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 4950 reaction mentions were counted: rash 1314; diarrhoea 1280; disease progression 547; dehydration 347. FAERS via Open Targets · CHEMBL1079742 · 2026-06-24

Show the evidence
  • rash
    1314
  • diarrhoea
    1280
  • disease progression
    547
  • dehydration
    347
  • drug resistance
    331
  • decreased appetite
    295
4 more recorded rows
  • malignant neoplasm progression
    255
  • dermatitis acneiform
    201
  • dry skin
    198
  • pleural effusion
    182

recorded 2026-06-24 · last checked 2026-09-04

Which 10 reactions does Erlotinib's label not list?

decreased appetite, dehydration and dermatitis acneiform and 7 more reported for Erlotinib, absent from its label. FAERS via Open Targets · CHEMBL1079742 · 2026-06-24

2 label terms; 10 reported and unlisted; a3b2d622-b4d5-4819-862b-f8fd3adcec6f

Show the evidence
  • decreased appetite
    count not stated
  • dehydration
    count not stated
  • dermatitis acneiform
    count not stated
  • diarrhoea
    count not stated
  • disease progression
    count not stated
  • drug resistance
    count not stated
4 more recorded rows
  • dry skin
    count not stated
  • malignant neoplasm progression
    count not stated
  • pleural effusion
    count not stated
  • rash
    count not stated

recorded 2026-06-24 · last checked 2026-09-04

Erlotinib and CYP1A2 and CYP3A4: shared by which compounds?

CYP1A2 and CYP3A4 appear in Erlotinib's recorded interaction sentences, 8 in all. DailyMed label · a3b2d622-b4d5-4819-862b-f8fd3adcec6f · 2024-06-26

CYP1A2, CYP1A2, CYP1A2, CYP3A4, CYP3A4, CYP3A4; 6 shared nodes; drug_interactions

Show the evidence

Interaction statement

  • drug_interactions
    CYP3A4 Inhibitors Co-administration of erlotinib with a strong CYP3A4 inhibitor or a combined CYP3A4 and CYP1A2 inhibitor increased erlotinib exposure.
  • drug_interactions
    Erlotinib is metabolized primarily by CYP3A4 and to a lesser extent by CYP1A2.
  • drug_interactions
    Avoid co-administering erlotinib with strong CYP3A4 inhibitors (e.g., boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, voriconazole, grapefruit or grapefruit juice) or a combined CYP3A4 and CYP1A2 inhibitor (e.g., ciprofloxacin).
  • drug_interactions
    Reduce the erlotinib dosage when co-administering with a strong CYP3A4 inhibitor or a combined CYP3A4 and CYP1A2 inhibitor if co-administration is unavoidable [see Dosage and Administration (2.4) ].
  • drug_interactions
    CYP3A4 Inducers Pre-treatment with a CYP3A4 inducer prior to erlotinib decreased erlotinib exposure [see Clinical Pharmacology (12.3) ].
  • drug_interactions
    Increase the erlotinib dosage if co-administration with CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, rifabutin, rifapentine, phenobarbital and St.
2 more recorded rows
  • Interaction statement drug_interactions
    CYP1A2 Inducers and Cigarette Smoking Cigarette smoking decreased erlotinib exposure.
  • Interaction statement drug_interactions
    Avoid smoking tobacco (CYP1A2 inducer) and avoid concomitant use of erlotinib with moderate CYP1A2 inducers (e.g., teriflunomide, rifampin, or phenytoin).

CYP1A2

  • FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Golodirsen, Tinidazole
  • FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Golodirsen, Tinidazole
  • FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Golodirsen, Tinidazole

CYP3A4

  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium
  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium
  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium

recorded 2024-06-26 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1079742
PubChem CID
176871
CAS number
183319-69-9
RxCUI
477320
InChIKey
AAKJLRGGTJKAMG-UHFFFAOYSA-N
Also called
Erlotinib hydrochloride
Development code
CP-358, CP-358,774-01, CP-358774-01, OSI-774, CP-358,774, CP-358774, CP-35877401, R-1415, RG-1415, Ro-508231
Salt form
Erlotinib hcl, Erlotinib Hydrochloride / Tarceva
Trade name
Tarceva, Erlotinib Accord
Also called
nsc 718781, egfr-tki, egfr-tkis, gefitinib, icotinib, tarcevatm, tki, 4-QUINAZOLINAMINE, N-(3-ETHYNYLPHENYL)-6,7-BIS(2-METHOXYETHOXY)-, MONOHYDROCHLORIDE, ERLOTINIB HYDROCHLORIDE [JAN], ERLOTINIB HYDROCHLORIDE [MART.], ERLOTINIB HYDROCHLORIDE [MI], ERLOTINIB HYDROCHLORIDE [ORANGE BOOK]
Component
Erlotinib hydrochloride
Sources (6)

Sources

ChEMBL 37 — CC BY-SA 3.0 Unported · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 6 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

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