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Sotorasib

  • 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 Sotorasib does in the body

LUMAKRAS is an inhibitor of the RAS GTPase family indicated for: KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy.

From the FDA-approved label: Sotorasib is an inhibitor of KRAS G12C, a tumor-restricted, mutant-oncogenic form of the RAS GTPase, KRAS. Sotorasib forms an irreversible, covalent bond with the unique cysteine of KRAS G12C, locking the protein in an inactive state that prevents downstream signaling without affecting wild-type KRAS. Sotorasib blocked KRAS signaling, inhibited cell growth, and promoted apoptosis only in KRAS G12C tumor cell lines. Sotorasib inhibited KRAS G12C in vitro and in vivo with minimal detectable off-target activity. In mouse tumor xenograft models, sotorasib-treatment led to tumor regressions and prolonged survival, and was associated with anti-tumor immunity in KRAS G12C models.

Why people take it. LUMAKRAS is an inhibitor of the RAS GTPase family indicated for: KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy.

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 · 2B2VM6UC8G · read 2026-08-29

  • Its recorded molecular formula is C30H30F2N6O3, weighing 560.6 g/mol.

    US prescribing information · c80a362c-7ac3-4894-a076-0691e68ef8c1 · 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 223 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.

Accrual of patients to ComboMATCH treatment trials

The study did not show it

Who was studied
NCT05564377
How many people
2900
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

Progression-free Survival (PFS)

The study did not show it

Who was studied
NCT05920356
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

Overall survival

The study did not show it

Who was studied
NCT06481813
How many people
730
Study design
Not applicable
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

Primary: Number of subjects with treatment-emergent adverse events

The study did not show it

Who was studied
NCT03600883
How many people
713
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

Number of Participants with Dose Limiting Toxicities (DLTs)

The study did not show it

Who was studied
NCT04185883
How many people
610
Study design
Phase 1
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

Detection of KRAS G12C mutation status

The study did not show it

Who was studied
NCT06645236
How many people
600
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
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.

  • LUMAKRAS is an inhibitor of the RAS GTPase family indicated for: KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy.

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 LUMAKRAS have not been established in pediatric patients.”

    US prescribing information · c80a362c-7ac3-4894-a076-0691e68ef8c1 · read 2026-08-30

  • On older people, the label states: “Of the 357 patients with any tumor type who received LUMAKRAS 960 mg orally once daily in CodeBreaK 100, 46% were 65 and over, and 10% were 75 and over.”

    US prescribing information · c80a362c-7ac3-4894-a076-0691e68ef8c1 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary There are no available data on LUMAKRAS use in pregnant women.”

    US prescribing information · c80a362c-7ac3-4894-a076-0691e68ef8c1 · read 2026-08-30

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

    US prescribing information · c80a362c-7ac3-4894-a076-0691e68ef8c1 · read 2026-08-30

  • On people with reduced liver function, the label states: “No dosage modification is recommended in patients with mild to moderate hepatic impairment (Child-Pugh A or B).”

    US prescribing information · c80a362c-7ac3-4894-a076-0691e68ef8c1 · 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, S4.

No source is stored against this line.

What is in the pack

Sold as tablet, tablet, 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

  • 7 products list this as an active ingredient in the United States drug directory. 7 of them contain it and nothing else.

    FDA National Drug Code directory · 63482-802 · read 2026-08-29

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

    FDA National Drug Code directory · 63482-802 · read 2026-08-29

  • 1 published label names it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · c80a362c-7ac3-4894-a076-0691e68ef8c1 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · c80a362c-7ac3-4894-a076-0691e68ef8c1 · read 2026-08-29

  • LUMAKRAS is oral at 3 DOSAGE FORMS AND STRENGTHS Tablets: 320 mg, beige, oval-shaped, immediate release, film-coated, debossed with "AMG" on one side and "320" on the opposite side., recorded as fda label in effect 2025-01-22 in the United States.

    US prescribing information · c80a362c-7ac3-4894-a076-0691e68ef8c1 · 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 Sotorasib 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.

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.

Where else this substance is registered

FDA substance identifier (UNII)
2B2VM6UC8G
RxNorm concept
2550719

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, 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 NDA214665, approved 20210528 to AMGEN INC.

    Drugs@FDA application register · NDA214665 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · NDA214665 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20210528.

    FDA National Drug Code directory · 63482-802 · 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 Sotorasib label: indicated for what?

"LUMAKRAS is an inhibitor of the RAS GTPase family indicated for: KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have…": indications and usage on Sotorasib's label. DailyMed label · c80a362c-7ac3-4894-a076-0691e68ef8c1 · 2025-01-22

53 registered trials of Sotorasib — at which phases?

Registered studies posting no result
44 of 53

53 registered studies of Sotorasib: 29 phase1, 22 phase2, 4 phase3, 3 na or unstated, 1 early phase1, 1 phase4. CLINICALTRIALS_SNAPSHOT · 2026-09-01

21 with a PubMed record

Show the evidence
  • phase1
    29
  • phase2
    22
  • phase3
    4
  • na or unstated
    3
  • early phase1
    1
  • phase4
    1
8 more recorded rows
  • completed
    17
  • recruiting
    14
  • active not recruiting
    6
  • terminated
    5
  • unknown
    4
  • withdrawn
    4
  • not yet recruiting
    2
  • no longer available
    1

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

9 of Sotorasib's trials stopped: safety, futility/efficacy, funding/business, sponsor decision unspecified, other?

safety (1), futility/efficacy (1), funding/business (1), sponsor decision unspecified (1) and other (5): Sotorasib's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Trial terminated due to business decision, not based on any safety or efficacy concerns."; 9 of 53 registered studies

Show the evidence

Trial

  • NCT04892017
    terminated; "Trial terminated due to business decision, not based on any safety or efficacy concerns."
  • NCT04933695
    terminated; "Futility"
  • NCT05036291
    terminated; "Development change"
  • NCT05251038
    withdrawn; "Funder Decision"
  • NCT05374538
    terminated; "Sponsor decision"
  • NCT05480865
    terminated; "Business Reasons"
3 further recorded trials
  • NCT05815186
    withdrawn; "Study record has been combined with NCT05815173 (Phase I/II study)."
  • NCT06061523
    withdrawn; "FDA and EMA agreed existing data are appropriate for approval and no further BE studies are required."
  • NCT06068153
    withdrawn; "In view of the recent developments in the field (the increasing number of trials with new KRAS inhibitors), the window of opportunity to answer the question raised in the AMBER trial was missed."

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

Human studies of Sotorasib used Sotorasib 960mg — over how long?

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

1 recorded entry; human; also "Sotorasib 960mg"

Show the evidence
  • human NCT06314763
    Sotorasib 960mg

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

Sotorasib's half-life is 5 hours — which schedules were studied?

5 hours, the half-life Sotorasib's label states: "Elimination The sotorasib mean terminal elimination half-life is 5 hours (standard deviation (SD): 2)." DailyMed label · c80a362c-7ac3-4894-a076-0691e68ef8c1 · 2025-01-22

tmax 1 hour.

Show the evidence
  • half life pharmacokinetics
    5 hours; Elimination The sotorasib mean terminal elimination half-life is 5 hours (standard deviation (SD): 2).
  • tmax pharmacokinetics
    1 hour; Absorption The median time to sotorasib peak plasma concentration is 1 hour.
  • metabolism pharmacokinetics
    Metabolism The main metabolic pathways of sotorasib are non-enzymatic conjugation and oxidative metabolism with CYP3As.

recorded 2025-01-22 · last checked 2026-09-04

Which running trial of Sotorasib could settle lifespan?

NCT05398094 measures Efficacy of the treatment in terms of the Progression Free Survival (PFS), reading out 2028-12-31.

5 open trials; n 19; "Clinical Trial of AMG510 in Stage III Unresectable NSCLC KRAS p.G12C Patients and Ineligible for Chemo-radiotherapy"

Show the evidence

Trial

  • NCT05398094
    "Clinical Trial of AMG510 in Stage III Unresectable NSCLC KRAS p.G12C Patients and Ineligible for Chemo-radiotherapy"; n 19; "Efficacy of the treatment in terms of the Progression Free Survival (PFS)"; 2028-12-31
  • NCT05638295
    "Testing the Use of AMG 510 (Sotorasib) and Panitumumab as a Targeted Treatment for KRAS G12C Mutant Solid Tumor Cancers (A ComboMATCH Treatment Trial)"; n 105; "Progression-free survival (PFS) (Cohort I)"; 2028-12-31
  • NCT07543172
    "CIMAvax-EGF With KRAS G12C Inhibitor for the Treatment of Advanced, KRAS G12C Mutated Non Small Cell Lung Cancer"; n 29; "Progression free survival (PFS)"; 2029-06-01
  • NCT06497556
    "A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer"; n 338; "Progression-Free Survival (PFS)"; 2029-11-30
  • NCT05920356
    "A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)"; n 750; "Progression-free Survival (PFS)"; 2032-06-29

Which 7 trials of Sotorasib posted no result?

Posted no result
7 of 7 completed trials
Registrations
NCT05598281, NCT05581758, NCT05581992, NCT05599828, NCT04959981 and NCT04720976, and 1 more
Completion dates
oldest 2019-11-19; newest 2024-03-21
Show the evidence

Trial

  • NCT05598281
    2019-11-19
  • NCT05581758
    2019-12-09
  • NCT05581992
    2020-01-26
  • NCT05599828
    2020-09-13
  • NCT04959981
    2023-04-27
  • NCT04720976
    2023-12-19
  • 1 further recorded trial NCT06314763
    2024-03-21

At the median, Sotorasib's trials enrolled 38 people — anything larger?

Median enrolment
38
Largest enrolment
2900
Registered trials counted
52

What do 14 spontaneous reports say about Sotorasib — 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.

Sotorasib appears in spontaneous reports to regulators. Across the 2 most-reported reaction terms, 14 reaction mentions were counted: non-small cell lung cancer 12; non-small cell lung cancer metastatic 2. FAERS via Open Targets · CHEMBL4535757 · 2026-06-24

Show the evidence
  • non-small cell lung cancer
    12
  • non-small cell lung cancer metastatic
    2

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

Which 2 reactions does Sotorasib's label not list?

non-small cell lung cancer and non-small cell lung cancer metastatic reported for Sotorasib, absent from its label. FAERS via Open Targets · CHEMBL4535757 · 2026-06-24

2 label terms; 2 reported and unlisted; c80a362c-7ac3-4894-a076-0691e68ef8c1

Show the evidence
  • non-small cell lung cancer
    count not stated
  • non-small cell lung cancer metastatic
    count not stated

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

Sotorasib and CYP3A4 and P-GP: shared by which compounds?

CYP3A4 and P-GP appear in Sotorasib's recorded interaction sentences, 8 in all. DailyMed label · c80a362c-7ac3-4894-a076-0691e68ef8c1 · 2025-01-22

CYP3A4, CYP3A4, P-gp; 3 shared nodes; drug_interactions

Show the evidence

Interaction statement

  • drug_interactions
    ( 2.4 , 7.1 ) Strong CYP3A4 Inducers: Avoid coadministration with strong CYP3A4 inducers.
  • drug_interactions
    ( 7.1 ) CYP3A4 Substrates: Avoid coadministration with CYP3A4 substrates for which minimal concentration changes may lead to therapeutic failures of the substrate.
  • drug_interactions
    ( 7.2 ) P-gp substrates: Avoid coadministration with P-gp substrates for which minimal concentration changes may lead to serious toxicities.
  • drug_interactions
    Strong CYP3A4 Inducers Sotorasib is a CYP3A4 substrate.
  • drug_interactions
    Coadministration of LUMAKRAS with a strong CYP3A4 inducer decreased sotorasib concentrations [see Clinical Pharmacology (12.3) ] , which may reduce the efficacy of sotorasib.
  • drug_interactions
    Avoid coadministration of LUMAKRAS with strong CYP3A4 inducers .
2 more recorded rows
  • Interaction statement drug_interactions
    7.2 Effects of LUMAKRAS on Other Drugs CYP3A4 Substrates Sotorasib is a CYP3A4 inducer.
  • Interaction statement drug_interactions
    Coadministration of LUMAKRAS with a CYP3A4 substrate decreased its plasma concentrations [see Clinical Pharmacology (12.3) ] , which may reduce the efficacy of the substrate.

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

recorded 2025-01-22 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL4535757
PubChem CID
137278711
CAS number
2296729-00-3
RxCUI
2550714
InChIKey
NXQKSXLFSAEQCZ-SFHVURJKSA-N
Also called
AMG-510, AMG510, CT-AMG510AMG-510AMG510, KRAS G12C INHIBITOR 9, KRAS MUTANT-TARGETING AMG 510, LUMAKRAS, LUMYKRAS, (R)-38, SOTORASIB (AMG510) RACEMATE, SOTORASIB [JAN], SOTORASIB [ORANGE BOOK], SOTORASIB [USAN]
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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