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Lorlatinib

  • 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 Lorlatinib does in the body

Metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by

From the FDA-approved label: Lorlatinib is a kinase inhibitor with in vitro activity against ALK and ROS1 as well as TYK1, FER, FPS, TRKA, TRKB, TRKC, FAK, FAK2, and ACK. Lorlatinib demonstrated in vitro activity against multiple mutant forms of the ALK enzyme, including some mutations detected in tumors at the time of disease progression on crizotinib and other ALK inhibitors. In mice subcutaneously implanted with tumors harboring EML4 fusions with either ALK variant 1 or ALK mutations, including the G1202R and I1171T mutations detected in tumors at the time of disease progression on ALK inhibitors, administration of lorlatinib resulted in antitumor activity.

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 · OSP71S83EU · read 2026-08-29

  • Its recorded molecular formula is C21H19FN6O2, weighing 406.41 Daltons.

    US prescribing information · 2b34d62d-e02a-4af3-bc0d-1571dd4ee76d · read 2026-08-30

Where each sentence above came from

The recorded explanation is written in label language rather than for a beginner. The page opens with what it is taken for instead, and the recorded explanation follows below.

Shown as the opening line on this page.

No statement of the main limit is recorded.

The four opening statements run to 133 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.

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

Percentage of patients that are treated based on their molecular tumor profile

The study did not show it

Who was studied
NCT02925234
How many people
1550
Study design
Phase 2
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

Dose limiting toxicities (DLTs) (Phase 1)

The study did not show it

Who was studied
NCT05384626
How many people
840
Study design
Phase 1/Phase 2
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

Event free survival (EFS) (Arm A, B, D, and E)

The study did not show it

Who was studied
NCT03126916
How many people
750
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

Number of Participants With Cycle 1 Dose-Limiting Toxicities (DLTs) in Phase 1

The study did not show it

Who was studied
NCT01970865
How many people
364
Study design
Phase 1/Phase 2
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) Based on Blinded Independent Central Review (BICR) Assessment

The study did not show it

Who was studied
NCT03052608
How many people
296
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.

  • LORBRENA ® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.

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 LORBRENA in pediatric patients have not been established.”

    US prescribing information · 2b34d62d-e02a-4af3-bc0d-1571dd4ee76d · read 2026-08-30

  • On older people, the label states: “Of the patients in Study B7461001 (N=295) and Study B7461006 (N=149) who received 100 mg LORBRENA orally once daily, 18% and 40% of patients, respectively, were aged 65 years or older.”

    US prescribing information · 2b34d62d-e02a-4af3-bc0d-1571dd4ee76d · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1) ] , LORBRENA can cause embryo-fetal harm when administered to a pregnant woman.”

    US prescribing information · 2b34d62d-e02a-4af3-bc0d-1571dd4ee76d · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of lorlatinib or its metabolites in either human or animal milk or its effects on the breastfed infant or on milk production.”

    US prescribing information · 2b34d62d-e02a-4af3-bc0d-1571dd4ee76d · read 2026-08-30

  • On people with reduced liver function, the label states: “In patients with severe hepatic impairment (Child-Pugh C), the recommended dosage of LORBRENA is 50 mg orally once daily [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3) ] .”

    US prescribing information · 2b34d62d-e02a-4af3-bc0d-1571dd4ee76d · read 2026-08-30

  • On people with reduced kidney function, the label states: “In patients with CL cr 15 to <30 mL/min (estimated by Cockcroft‑Gault), the recommended dosage of LORBRENA is 75 mg orally once daily [see Dosage and Administration (2.6) and Clinical Pharmacology (12.3) ] .”

    US prescribing information · 2b34d62d-e02a-4af3-bc0d-1571dd4ee76d · 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

  • 5 products list this as an active ingredient in the United States drug directory. 5 of them contain it and nothing else.

    FDA National Drug Code directory · 53869-1043 · read 2026-08-29

  • They are sold as tablet, film coated, taken oral.

    FDA National Drug Code directory · 53869-1043 · read 2026-08-29

  • The regulator's established pharmacologic class for it is breast cancer resistance protein inhibitors [moa], cytochrome p450 2b6 inducers [moa] and cytochrome p450 3a inducers [moa].

    FDA National Drug Code directory · 53869-1043 · read 2026-08-29

  • 2 published labels name it as an active ingredient. 2 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 2b34d62d-e02a-4af3-bc0d-1571dd4ee76d · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 2b34d62d-e02a-4af3-bc0d-1571dd4ee76d · read 2026-08-29

  • Lorbrena is oral at 3 DOSAGE FORMS AND STRENGTHS Tablets: • 25 mg: 8 mm round, tan, immediate release, film-coated, debossed with "Pfizer" on one side and "25" and "LLN" on the other side • 100 mg: 8.5 mm × 17 mm oval, lavender, immediate…, recorded as fda label in effect 2026-06-26 in the United States.

    US prescribing information · 2b34d62d-e02a-4af3-bc0d-1571dd4ee76d · 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 Lorlatinib 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 Lorlatinib 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

  • 2 documents were read for this substance.

    RNAWiki source record

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

    RNAWiki source record

  • 2 of them state the same tMax, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
OSP71S83EU
RxNorm concept
2103169

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: Written into the record, not signed off.

  • 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

  • 1 approved application covers products containing this substance. The earliest was NDA210868, approved 20181102 to PFIZER.

    Drugs@FDA application register · NDA210868 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · NDA210868 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20180805.

    FDA National Drug Code directory · 53869-1043 · 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 (10)

On the Lorlatinib label: indicated for what?

"LORBRENA ® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. LORBRENA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung…": indications and usage on Lorlatinib's label. DailyMed label · 2b34d62d-e02a-4af3-bc0d-1571dd4ee76d · 2026-06-26

65 registered trials of Lorlatinib — at which phases?

Registered studies posting no result
50 of 65

65 registered studies of Lorlatinib: 25 phase2, 18 na or unstated, 16 phase1, 5 phase4, 3 phase3, 1 early phase1, 1 na. CLINICALTRIALS_SNAPSHOT · 2026-09-01

42 with a PubMed record

Show the evidence
  • phase2
    25
  • na or unstated
    18
  • phase1
    16
  • phase4
    5
  • phase3
    3
  • early phase1
    1
11 more recorded rows
  • na
    1
  • completed
    19
  • recruiting
    13
  • active not recruiting
    10
  • terminated
    7
  • not yet recruiting
    6
  • unknown
    6
  • approved for marketing
    1
  • enrolling by invitation
    1
  • no longer available
    1
  • withdrawn
    1

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

8 of Lorlatinib's trials stopped: safety, accrual/recruitment, funding/business, other?

safety (1), accrual/recruitment (4), funding/business (2) and other (1): Lorlatinib's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"The study was terminated since there was no need for further safety or efficacy data to be collected. The participants having benefit from the Investigational treatments have been moved to a continuation study (NCT05059522)"; 8 of 65 registered studies

Show the evidence

Trial

  • NCT02584634
    terminated; "The study was terminated since there was no need for further safety or efficacy data to be collected. The participants having benefit from the Investigational treatments have been moved to a continuation study (NCT05059522)"
  • NCT03726333
    terminated; "The study stopped due to lack of enrollment"
  • NCT03737994
    terminated; "Inadequate accrual rate"
  • NCT03878524
    terminated; "Low accrual"
  • NCT04753658
    terminated; "The study was prematurely discontinued due to operational implementation challenges and insufficient collection of key data due to varied data accessibility across global study sites."
  • NCT04800822
    terminated; "The study was prematurely discontinued due to strategic reasons. The PF-07284892 program will continue"
2 further recorded trials
  • NCT05097599
    terminated; "Business decision and enrollment difficulties"
  • NCT05948462
    withdrawn; "Study withdrawn by pharmaceutical funding partner"

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

Human studies of Lorlatinib used Lorlatinib 50 mg — over how long?

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

3 recorded entries; human; also "Lorlatinib 50 mg", "Lorlatinib 75 mg", "Lorlatinib 100 mg"

Show the evidence

human

  • NCT03961997
    Lorlatinib 50 mg
  • NCT03961997
    Lorlatinib 75 mg
  • NCT03961997
    Lorlatinib 100 mg

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

Which running trial of Lorlatinib could settle lifespan?

NCT04127110 measures Progression-free survival (PFS), reading out 2024-11.

7 open trials; n 68; "Activity of Lorlatinib Based on ALK Resistance Mutations Detected on Blood in ALK Positive NSCLC Patients"

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Trial

  • NCT04127110
    "Activity of Lorlatinib Based on ALK Resistance Mutations Detected on Blood in ALK Positive NSCLC Patients"; n 68; "Progression-free survival (PFS)"; 2024-11
  • NCT05014464
    "ALK Tyrosine Kinase Inhibitors in ALK-rearranged Advanced Squamous Cell Carcinoma"; n 90; "Progression-free survival (PFS)"; 2027-08-08
  • NCT06378892
    "A Study to Evaluate the Combination of Platinum-pemetrexed Based Chemotherapy Plus Lorlatinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) With Exclusively Extracranial Disease Progression on Lorlatinib"; n 45; "Compare Progression Free Survival between patients treated with Pemetrexed (PT)/pem-based chemotherapy plus Lorlatinib after Lorlatinib versus retrospective data of 3,2 months for patients treated with PT/pem-based chemotherapy after…"; 2028-05
  • NCT06487078
    "Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients in a French Real-World Context"; n 90; "Progression-Free Survival (PFS)"; 2028-11-30
  • NCT03052608
    "A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC"; n 296; "Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) Assessment"; 2028-12-31
  • NCT06858410
    "Lorlatinib Compared with Concurrent/ Sequential Chemoradiotherapy in Stage III ALK Positive Lung Adenocarcinoma"; n 36; "Progression Free Survival (PFS)"; 2030-08
  • 1 further recorded trial NCT03126916
    "Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)"; n 750; "Event free survival (EFS) (Arm A, B, D, and E)"; 2030-09-30

Which 6 trials of Lorlatinib posted no result?

Posted no result
6 of 6 completed trials
Registrations
NCT02569554, NCT02838264, NCT03961997, NCT05167500, NCT03546894 and NCT05224609
Completion dates
oldest 2016-04; newest 2024-08-13
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Trial

  • NCT02569554
    2016-04
  • NCT02838264
    2017-05-03
  • NCT03961997
    2019-12-09
  • NCT05167500
    2022-12-30
  • NCT03546894
    2023-02-13
  • NCT05224609
    2024-08-13

At the median, Lorlatinib's trials enrolled 53 people — anything larger?

Median enrolment
53
Largest enrolment
5279
Registered trials counted
63

What do 379 spontaneous reports say about Lorlatinib — 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.

Lorlatinib appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 379 reaction mentions were counted: neoplasm progression 78; hypercholesterolaemia 50; oedema peripheral 39; oedema 38. FAERS via Open Targets · CHEMBL3286830 · 2026-06-24

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  • neoplasm progression
    78
  • hypercholesterolaemia
    50
  • oedema peripheral
    39
  • oedema
    38
  • hypertriglyceridaemia
    35
  • blood cholesterol increased
    33
4 more recorded rows
  • cognitive disorder
    30
  • confusional state
    28
  • pleural effusion
    24
  • weight increased
    24

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

Which 10 reactions does Lorlatinib's label not list?

blood cholesterol increased, cognitive disorder and confusional state and 7 more reported for Lorlatinib, absent from its label. FAERS via Open Targets · CHEMBL3286830 · 2026-06-24

2 label terms; 10 reported and unlisted; 2b34d62d-e02a-4af3-bc0d-1571dd4ee76d

Show the evidence
  • blood cholesterol increased
    count not stated
  • cognitive disorder
    count not stated
  • confusional state
    count not stated
  • hypercholesterolaemia
    count not stated
  • hypertriglyceridaemia
    count not stated
  • neoplasm progression
    count not stated
4 more recorded rows
  • oedema
    count not stated
  • oedema peripheral
    count not stated
  • pleural effusion
    count not stated
  • weight increased
    count not stated

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

Lorlatinib and CYP3A and P-GP: shared by which compounds?

CYP3A and P-GP appear in Lorlatinib's recorded interaction sentences, 8 in all. DailyMed label · 2b34d62d-e02a-4af3-bc0d-1571dd4ee76d · 2026-06-26

CYP3A, CYP3A, CYP3A, P-gp; 4 shared nodes; drug_interactions

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Interaction statement

  • drug_interactions
    • Strong CYP3A Inducers : Contraindicated.
  • drug_interactions
    ( 2.4 , 7.1 ) • Moderate CYP3A Inducers : Avoid concomitant use.
  • drug_interactions
    ( 2.4 , 7.1 ) • Strong CYP3A Inhibitors : Avoid concomitant use; reduce LORBRENA dose if concomitant use cannot be avoided.
  • drug_interactions
    ( 2.4 , 7.1 ) • Certain CYP3A Substrates : Avoid concomitant use with CYP3A substrates for which minimal concentration changes may lead to serious therapeutic failures.
  • drug_interactions
    ( 7.2 ) • Certain P-gp Substrates : Avoid concomitant use with P-gp substrates for which minimal concentration changes may lead to serious therapeutic failures.
  • drug_interactions
    ( 7.2 ) 7.1 Effect of Other Drugs on LORBRENA Strong CYP3A Inducers LORBRENA is contraindicated in patients taking strong CYP3A inducers [see Contraindication (4) ] .
2 more recorded rows
  • Interaction statement drug_interactions
    Discontinue strong CYP3A inducers for 3 plasma half-lives of the strong CYP3A inducer prior to initiating LORBRENA [see Dosage and Administration (2.3) ] .
  • Interaction statement drug_interactions
    Concomitant use of LORBRENA with a strong CYP3A inducer decreased lorlatinib plasma concentrations [see Clinical Pharmacology (12.3) ] , which may decrease the efficacy of LORBRENA.

CYP3A

  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, Vincristine, Naldemedine, Pemetrexed, Eravacycline, Rasburicase, Repotrectinib
  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, Vincristine, Naldemedine, Pemetrexed, Eravacycline, Rasburicase, Repotrectinib
  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, Vincristine, Naldemedine, Pemetrexed, Eravacycline, Rasburicase, Repotrectinib
  • P-gp
    FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Vincristine

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

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL3286830
PubChem CID
71731823
CAS number
1454846-35-5
RxCUI
2103164
InChIKey
IIXWYSCJSQVBQM-LLVKDONJSA-N
Trade name
Lorbrena, Lorviqua
Development code
PF-06463922
Also called
LORLATINIB [JAN], LORLATINIB [MI], LORLATINIB [ORANGE BOOK], LORLATINIB [USAN], Lorlatinib [WHO-DD], lorlatinib [INN]
Sources (6)

Sources

ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · 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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