NCT04933695 (CodeBreaK201) is a Phase 2 clinical trial of Sotorasib in Non-small Cell Lung Cancer, sponsored by Amgen.

Who is sponsoring NCT04933695?

NCT04933695 is sponsored by Amgen.

What drugs are being tested in NCT04933695?

Interventions in NCT04933695: Sotorasib.

What condition does NCT04933695 study?

NCT04933695 studies Non-small Cell Lung Cancer.

Is NCT04933695 still recruiting?

NCT04933695 is currently completed. Last updated 22 October 2025.

Last reviewed 2025-10-22 · How we verify

NCT04933695: CodeBreaK201

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatment

Completed Phase 2 Last updated 22 October 2025

What this trial tests

Phase 2 trial testing Sotorasib in Non-small Cell Lung Cancer in 42 participants. Completed in 27 May 2025.

Timeline

28 January 2022

Primary endpoint
27 May 2025

27 May 2025

Quick facts

Lead sponsor	Amgen
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	42
Start date	28 January 2022
Primary completion	27 May 2025
Estimated completion	27 May 2025
Sites	67 locations across Denmark, France, Italy, Netherlands, Belgium, Sweden, Germany, United States

Drugs / interventions tested

Sotorasib (SOTORASIB) — full drug profile →

Conditions studied

Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →

Sponsor

Amgen — full company profile →

Who can join

18 and older, any sex, with Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The main objective of this study is to evaluate the tumor objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in participants who receive sotorasib at either 960 mg daily or 240 mg daily whose tumors are programmed death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) \< 1% and/or harbor a serine/threonine kinase 11 (STK11) co-mutation, in a subgroup of participants with PD-L1 \< 1% and in a subgroup of participants with STK11 co-mutation.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

The current state of the art and future trends in RAS-targeted cancer therapies.
Punekar SR, Velcheti V, Neel BG, Wong KK. · · 2022 · cited 382× · PMID 36028717 · DOI 10.1038/s41571-022-00671-9
Expanding the Reach of Precision Oncology by Drugging All KRAS Mutants.
Hofmann MH, Gerlach D, Misale S, Petronczki M, et al · · 2022 · cited 247× · PMID 35046095 · DOI 10.1158/2159-8290.cd-21-1331
Recent advances in non-small cell lung cancer targeted therapy; an update review.
Araghi M, Mannani R, Heidarnejad Maleki A, Hamidi A, et al · · 2023 · cited 211× · PMID 37568193 · DOI 10.1186/s12935-023-02990-y
Comutations and KRASG12C Inhibitor Efficacy in Advanced NSCLC.
Negrao MV, Araujo HA, Lamberti G, Cooper AJ, et al · · 2023 · cited 162× · PMID 37068173 · DOI 10.1158/2159-8290.cd-22-1420
The path to the clinic: a comprehensive review on direct KRAS<sup>G12C</sup> inhibitors.
Kwan AK, Piazza GA, Keeton AB, Leite CA. · · 2022 · cited 142× · PMID 35045886 · DOI 10.1186/s13046-021-02225-w
Small molecule inhibitors targeting the cancers.
Liu GH, Chen T, Zhang X, Ma XL, et al · · 2022 · cited 127× · PMID 36254250 · DOI 10.1002/mco2.181
Progress on Ras/MAPK Signaling Research and Targeting in Blood and Solid Cancers.
Dillon M, Lopez A, Lin E, Sales D, et al · · 2021 · cited 99× · PMID 34680208 · DOI 10.3390/cancers13205059
Targeting KRAS in pancreatic cancer: new drugs on the horizon.
Bannoura SF, Uddin MH, Nagasaka M, Fazili F, et al · · 2021 · cited 81× · PMID 34499267 · DOI 10.1007/s10555-021-09990-2

Verify or expand the search:

Other trials of Sotorasib

Trials testing the same drug.

NCT07012031 — Sotorasib in Combination With Trastuzumab Deruxtecan for the Treatment of Locally Advanced and Metastatic Non-small Cell · Phase 1, PHASE2 · recruiting
NCT07318389 — ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer · EARLY_PHASE1 · not yet recruiting
NCT07172919 — A Rollover Study Evaluating Sotorasib With or Without Panitumumab in Participants With KRAS p.G12C Mutation · Phase 2 · recruiting
NCT07143513 — Real World Evaluation of Sotorasib Among Chinese Non-Small Cell Lung Cancer Patients · completed
NCT06804824 — A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid T · Phase 1 · recruiting

Other recruiting trials for Non-small Cell Lung Cancer

Currently open trials in the same condition.

NCT07431827 — MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013) · Phase 3 · recruiting
NCT05987956 — Pharmacogenomics IND EXEMPT SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms · Phase 2, PHASE3 · active not recruiting
NCT07195695 — Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer Wit · Phase 3 · recruiting
NCT06686771 — Radiotherapy to Block Oligoprogression In Metastatic Non-Small-Cell Lung Cancer · Phase 3 · recruiting
NCT06477055 — The Recurrence Gene Profiles of Adjuvant Osimertinib Therapy in Resected Non-Small-Cell Lung Cancer · recruiting

Other Amgen trials

Trials by the same sponsor.

NCT07223190 — A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With B-cell Precursor Acute Ly · Phase 3 · not yet recruiting
NCT07493512 — Trial of Xaluritamig in Adults With Metastatic Castration-resistant Prostate Cancer · Phase 1 · not yet recruiting
NCT07531095 — Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC) · Phase 1 · not yet recruiting
NCT06987539 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Gen · Phase 2 · recruiting
NCT05909761 — Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregn · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04933695 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 22 October 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04933695.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing