Back to discover
Drug

Sotorasib

Approved · EMA
ClassGTPase KRas inhibitorEmerging researchLate-stage development

Also known as Lumakras.

RxNorm2550714ChEMBLCHEMBL4535757ATCL01XX73UNII2B2VM6UC8G
2
Research papers
21
Active clinical trials
GTPase KRas
Primary target
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 2 Study of First-line Sotorasib for Patients With Advanced KRAS G12C-mutant Non-small Cell Lung Cancer

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)

Clinical trial2026-07-16Results expected Q3 2028 · ClinicalTrials.gov

Molecular Analysis for Combination Therapy Choice (ComboMATCH)

Clinical trial2026-07-09Results expected Q3 2030 · ClinicalTrials.gov

A Phase I/II Study Evaluating the Safety, Tolerability, and Efficacy of Sotorasib Plus Trastuzumab Deruxtecan in Patients With Advanced Non-Small Cell Lung Cancer With a KRASG12C Mutation

Clinical trial2026-06-23Results expected Q2 2027 · ClinicalTrials.gov

ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer

Clinical trial2026-06-11Results expected Q4 2027 · ClinicalTrials.gov

A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)

Clinical trial2026-06-04Results expected Q2 2027 · ClinicalTrials.gov

A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Sotorasib (AMG 510) Monotherapy in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation and Sotorasib (AMG 510) Combination Therapy in Subjects With Advanced NSCLC With KRAS p.G12C Mutation (CodeBreaK 100)

Clinical trial2026-05-29Completed · ClinicalTrials.gov

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol)

Clinical trial2026-05-28Results expected Q4 2026 · ClinicalTrials.gov

BrainMet ADePPT (Anticancer Drug Penetration Platform Trial)

Clinical trial2026-05-22Results expected Q1 2028 · ClinicalTrials.gov

Sotorasib in <i>KRAS</i> p.G12C-Mutated Advanced Pancreatic Cancer.

Research2022-12-21The New England journal of medicine

Approval: Lumykras (EMA)

Regulatory2022-01-06EMA

EGFR Blockade Reverts Resistance to KRAS&lt;sup&gt;G12C&lt;/sup&gt; Inhibition in Colorectal Cancer.

Research2020-05-19Cancer discovery

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Sotorasib
Aliases & brands
Lumakras
RxNorm CUI
2550714
ChEMBL ID
CHEMBL4535757
ATC codes
L01XX73
UNII
2B2VM6UC8G
Primary mechanism
GTPase KRas inhibitor
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

GTPase KRas
KRAS · P01116
INHIBITORGTPase KRas inhibitor

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2022-01-06
Latest approval
2022-01-06
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2022-01-06Approval
Approval: Lumykras (EMA)
Indication: Lumykras as monotherapy is indicated for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and who have progressed after at least… Show full indication

Lumykras as monotherapy is indicated for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

44 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
44
registered trials across all phases
LATEST COMPLETION 2026
21
Active studies
16
Recruiting
5
Late-stage (III+)
13
Completed
10
Discontinued
PHASE DISTRIBUTIONn = 44
Early Phase 11Phase 116Phase 1 / 26Phase 216Phase 34Phase 41

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Rivaroxaban Sotorasib Interaction Study

CompletedPH IVRadboud University Medical Centern=212024

A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)

RecruitingPH IIIAmgenn=7502032

Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)

RecruitingPH IIIAmgenn=4502032

A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Patients With Previously Treated KRAS G12C-Positive Advanced or Metastatic Non-Small Cell Lung Cancer

Active, not recruitingPH IIIHoffmann-La Rochen=3382029

A Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib and Panitumumab Versus Investigator's Choice (Trifluridine and Tipiracil, or Regorafenib) for the Treatment of Previously Treated Metastatic Colorectal Cancer Subjects With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation

CompletedPH IIIAmgenn=1602026

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Sotorasib (AMG 510) Monotherapy in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation and Sotorasib (AMG 510) Combination Therapy in Subjects With Advanced NSCLC With KRAS p.G12C Mutation (CodeBreaK 100)

CompletedPH I/IIAmgenn=7132026

A Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib and Panitumumab Versus Investigator's Choice (Trifluridine and Tipiracil, or Regorafenib) for the Treatment of Previously Treated Metastatic Colorectal Cancer Subjects With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation

CompletedPH IIIAmgenn=1602026

A Randomized Phase II Study of Sotorasib Versus Continued Consolidation Durvalumab in Patients With KRAS G12C Mutant Locally Advanced Non-small Cell Lung Cancer (LANSCLC) With Persistent ctDNA Defined Minimal Residual Disease

CompletedPH IIMemorial Sloan Kettering Cancer Centern=102026

A Phase 2, Multicenter, Open-label Study of Sotorasib (AMG 510) in Subjects With Stage IV NSCLC Whose Tumors Harbor a KRAS G12C Mutation in Need of First-line Treatment (CodeBreaK 201)

CompletedPH IIAmgenn=422025

A Phase 2, Open-Label, Multicenter Study of the Combination of RMC-4630 and Sotorasib for Non-Small Cell Lung Cancer Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies

CompletedPH IIRevolution Medicines, Inc.n=472024

Rivaroxaban Sotorasib Interaction Study

CompletedPH IVRadboud University Medical Centern=212024

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20202023
Major research themes2
Immune Checkpoint Inhibitors1Pancreatic Neoplasms1
Journals, researchers & institutions
Top journals
  • Cancer discovery1
  • The New England journal of medicine1
Leading researchers
  • Yaeger R2
  • Amodio V1
  • Arcella P1
  • Arena S1
  • Bajor D1
  • Bardelli A1
  • Bertotti A1
  • Bhalkikar A1
Leading institutions
free-text, unnormalised
  • Candiolo Cancer Institute1
  • Center for Evolution and Cancer1
  • Center for Molecular-Based Therapy1
  • From Duke University Medical Center1
  • Memorial Sloan Kettering Cancer Center1
  • Niguarda Cancer Center1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.