Sotorasib versus docetaxel for previously treated non-small-cell lung cancer with KRASG12C mutation: a randomised, open-label, phase 3 trial
Open accessAbstract
Background Sotorasib is a specific, irreversible inhibitor of the GTPase protein, KRAS G12C. We compared the efficacy and safety of sotorasib with a standard-of-care treatment in patients with non-small-cell lung cancer (NSCLC) with the KRAS G12C mutation who had been previously treated with other anticancer drugs.Methods We conducted a randomised, open-label phase 3 trial at 148 centres in 22 countries. We recruited patients aged at least 18 years with KRAS G12C-mutated advanced NSCLC, who progressed after previous platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor. Key exclusion criteria included new or progressing untreated brain lesions or symptomatic brain lesions, previously identified oncogenic driver mutation other than KRAS G12C for which an approved therapy is available (eg EGFR or ALK), previous treatment with docetaxel (neoadjuvant or adjuvant docetaxel was allowed if the tumour did not progress within 6 months after the therapy was terminated), previous treatment with a direct KRAS G12C inhibitor, systemic anticancer therapy within 28 days of study day 1, and therapeutic or palliative radiation therapy within 2 weeks of treatment initiation. We randomly assigned (1:1) patients to oral sotorasib (960 mg once daily) or intravenous docetaxel (75 mg/m 2 once every 3 weeks) in an open-label manner using interactive response technology. Randomisation was stratified by number of previous lines of therapy in advanced disease (1 vs 2 vs >2), ethnicity (Asian vs non-Asian), and history of CNS metastases (present or absent). Treatment continued until an independent central confirmation of disease progression, intolerance, initiation of another anticancer therapy, withdrawal of consent, or death, whichever occurred first. The primary endpoint was progression-free survival, which was assessed by a blinded, independent central review in the intention-to-treat population. Safety was assessed in all treated patients. This trial is registered at ClinicalTrials.gov, NCT04303780, and is active but no longer recruiting.Findings Between June 4, 2020, and April 26, 2021, 345 patients were randomly assigned to receive sotorasib (n=171 [50%]) or docetaxel (n=174 [50%]). 169 (99%) patients in the sotorasib group and 151 (87%) in the docetaxel group received at least one dose. After a median follow-up of 17·7 months (IQR 16·4-20·1), the study met its primary endpoint of a statistically significant increase in the progression-free survival for sotorasib, compared with docetaxel (median progression-free survival 5·6 months [95% CI 4·3-7·8] vs 4·5 months [3·0-5·7]; hazard ratio 0·66 [0·51-0·86]; p=0·0017). Sotorasib was well tolerated, with fewer grade 3 or worse (n=56 [33%] vs n=61 [40%]) and serious treatment-related adverse events compared with docetaxel (n=18 [11%] vs n=34 [23%]). For sotorasib, the most common treatment-related adverse events of grade 3 or worse were diarrhoea (n= 20 [12%]), alanine aminotransferase increase (n=13 [8%]), and aspartate aminotransferase increase (n=9 [5%]). For docetaxel, the most common treatment-related adverse events of grade 3 or worse were neutropenia (n=13 [9%]), fatigue (n=9 [6%]), and febrile neutropenia (n=8 [5%]).Interpretation Sotorasib significantly increased progression-free survival and had a more favourable safety profile, compared with docetaxel, in patients with advanced NSCLC with the KRAS G12C mutation and who had been previously treated with other anticancer drugs.Funding Amgen.
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Clinical trials of multiple KRASG12C inhibitors have shown promising efficacy in advanced, previously treated NSCLC, leading to FDA accelerated approval of adagrasib and sotorasib.
“Clinical trials of multiple KRASG12C inhibitors have shown promising efficacy in advanced, previously treated non–small cell lung cancer (NSCLC), leading to United States Food and Drug Administration (FDA) accelerated approval of two of these therapies (adagrasib and sotorasib) and many others being investigated in this setting (9–17).”
From Mechanisms of Resistance to Oncogenic KRAS Inhibition in Pancreatic Cancer (2024) · cites this paper as [15]
The Introduction and Discussion report clinical efficacy for sotorasib in previously treated advanced KRAS G12C-mutated NSCLC, and Research in context says adagrasib has also been reported efficacious in this population. The passages do not state that either drug received FDA accelerated approval or that the trial results led to those approvals. (LLM, conf=0.86)
Experimental — accuracy not yet measuredSotorasib, adagrasib, and divarasib monotherapies have demonstrated objective response rates ranging from 7.1% to 53.4% and median progression-free survival of 4.0-13.1 months.
“For example, sotorasib, adagrasib, and divarasib monotherapies have demonstrated objective response rates ranging from 7.1% to 53.4% and median progression-free survival of 4.0-13.1 months, 13-20”
From Anti-tumor efficacy of HRS-4642 and its potential combination with proteasome inhibition in KRAS G12D-mutant cancer (2024) · cites this paper as [15]
The Results report a 28.1% objective response rate and 5.6-month median progression-free survival for sotorasib, both within the cited ranges. This trial does not establish the stated ranges or provide corresponding results for adagrasib and divarasib; the Results passages have no page number in our copy. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIn patients with non-small cell lung cancer, divarasib had a numerically higher ORR (56.4%) than sotorasib (37% in a phase 2 trial and 28% in a phase 3 trial) and adagrasib (43% in a phase 2 trial).
“This is further supported by a numerically higher ORR seen with divarasib in patients with non-small cell lung cancer (56.4%) compared with sotorasib (37% in a phase 2 trial and 28% in a phase 3 trial) and adagrasib (43% in a phase 2 trial)11,23–25.”
From Divarasib plus cetuximab in KRAS G12C-positive colorectal cancer: a phase 1b trial (2024) · cites this paper as [23]
In CodeBreaK 200, median overall survival was not improved with sotorasib compared with docetaxel (10.6 vs. 11.3 months; HR, 1.01).
“while median overall survival was not improved with sotorasib compared with docetaxel (10.6 vs. 11.3 months; HR, 1.01) [25]”
From Precision Targeting of KRAS-Mutant Cancers: Beyond G12C Toward G12D and Pan-RAS Therapeutic Strategies (2026) · cites this paper as [25]
In CodeBreaK 200, sotorasib significantly improved progression-free survival compared with docetaxel in previously treated KRAS G12C-mutant NSCLC (median PFS, 5.6 vs. 4.5 months; HR, 0.66).
“In the randomized phase III CodeBreaK 200 trial, sotorasib significantly improved progression-free survival compared with docetaxel in previously treated KRAS G12C-mutant NSCLC (median PFS, 5.6 vs. 4.5 months; HR, 0.66).”
From Precision Targeting of KRAS-Mutant Cancers: Beyond G12C Toward G12D and Pan-RAS Therapeutic Strategies (2026) · cites this paper as [25]
Some patients selected for these trials may have preexisting multidrug resistance, which could contribute to treatment failure.
“In addition, some patients selected for these trials may have preexisting multidrug resistance (9, 37, 74), which could contribute to treatment failure.”
From SRC kinase drives multidrug resistance induced by KRAS-G12C inhibition (2024) · cites this paper as [74]
The Results (page not available in our copy) report that some participants were refractory to previous therapy, and the eligibility passage says patients had progressed after prior treatment. Neither passage establishes preexisting multidrug resistance or links it to treatment failure; searches for multidrug resistance and resistance mechanisms found no such discussion. (LLM, conf=0.71)
Experimental — accuracy not yet measuredDisease progression occurs in many patients treated with KRASG12Ci, and resistance is recapitulated in preclinical studies.
“Despite this success, disease progression occurs in many patients4,5,7, with development of resistance to KRASG12Ci recapitulated in preclinical studies9–11.”
From Co-targeting SOS1 enhances the antitumor effects of KRASG12C inhibitors by addressing intrinsic and acquired resistance (2024) · cites this paper as [5]
Multiple intrinsic and acquired resistance mechanisms to G12C inhibitors are known, and drug combinations will likely be required to maximize their clinical efficacy in NSCLC and other diseases.
“Multiple mechanisms of intrinsic and acquired resistance (10,12,13), have been identified; hence, drug combinations will likely be needed to maximize the clinical efficacy of G12Cis (and probably other, emerging KRAS inhibitors) in NSCLC and other diseases.”
From Genome-Wide CRISPR Screens Identify Multiple Synthetic Lethal Targets That Enhance KRASG12C Inhibitor Efficacy (2023) · cites this paper as [13]
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MYC and KRAS cooperation: from historical challenges to therapeutic opportunities in cancer
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The next-generation KRAS inhibitors…What comes after sotorasib and adagrasib?
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Targeting KRAS: from metabolic regulation to cancer treatment
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RAS-ON inhibition overcomes clinical resistance to KRAS G12C-OFF covalent blockade
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Response and Resistance to RAS Inhibition in Cancer
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Lung Cancer: Targeted Therapy in 2025
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KRAS: the Achilles’ heel of pancreas cancer biology
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Molecular determinants of sotorasib clinical efficacy in KRASG12C-mutated non-small-cell lung cancer
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Self-citationEmerging Targets in Non-Small Cell Lung Cancer
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Current landscape of innovative drug development and regulatory support in China
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Lung cancer research and treatment: global perspectives and strategic calls to action
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Self-citationTargeting KRAS mutations in pancreatic cancer: opportunities for future strategies
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Targeted therapeutic options in early and metastatic NSCLC-overview
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Breakthrough in RAS targeting with pan-RAS(ON) inhibitors RMC-7977 and RMC-6236
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Facts and Hopes on RAS Inhibitors and Cancer Immunotherapy
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Self-citationLiquid Biopsies in Lung Cancer
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Sotorasib for Vascular Malformations Associated with KRAS G12C Mutation
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Glecirasib in KRASG12C-mutated nonsmall-cell lung cancer: a phase 2b trial
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Self-citationSmall molecular inhibitors for KRAS-mutant cancers
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From bench to bedside: current development and emerging trend of KRAS-targeted therapy
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Self-citationResistance to KRAS G12C Inhibition in Non-small Cell Lung Cancer
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Biological insights in non-small cell lung cancer
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KRAS G12C-mutant driven non-small cell lung cancer (NSCLC)
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Setidegrasib in Advanced Non–Small-Cell Lung Cancer and Pancreatic Cancer
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The current landscape of using direct inhibitors to target KRASG12C-mutated NSCLC
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Prognostic and therapeutic impact of the KRAS G12C mutation in colorectal cancer
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Emerging landscape of KRAS inhibitors in cancer treatment
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Targeting KRAS in Colorectal Cancer: A Bench to Bedside Review
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Top advances of the year: Targeted therapy for lung cancer
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Self-citationMechanisms of resistance to KRASG12C inhibitors in KRASG12C-mutated non-small cell lung cancer
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Molecular pathology of non‐small cell carcinoma
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Activity and resistance to KRASG12C inhibitors in non-small cell lung cancer and colorectal cancer
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RAS‐targeted cancer therapy: Advances in drugging specific mutations
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SRC kinase drives multidrug resistance induced by KRAS-G12C inhibition
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Small-molecule inhibition of MAP2K4 is synergistic with RAS inhibitors in KRAS -mutant cancers
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Beyond Chemoimmunotherapy in Advanced Non–Small Cell Lung Cancer: New Frontiers, New Challenges
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Self-citationKRAS mutations in advanced non-small cell lung cancer: From biology to novel therapeutic strategies
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Self-citationEmerging Targeted Therapies in Non-Small-Cell Lung Cancer (NSCLC)
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- Authors
- de Langen, A. J., Johnson, M. L., Mazieres, J., Dingemans, A.-M. C., Mountzios, G., Pless, M., Wolf, J., Schuler, M., Lena, H., Skoulidis, F., Yoneshima, Y., Kim, S.-W., Linardou, H., Novello, S., van der Wekken, A. J., Chen, Y., Peters, S., Felip, E., Solomon, B. J., Ramalingam, S. S., Dooms, C., Lindsay, C. R., Ferreira, C. G., Blais, N., Obiozor, C. C., Wang, Y., Mehta, B., Varrieur, T., Ngarmchamnanrith, G., Stollenwerk, B., Waterhouse, D., & Paz-Ares, L.
- Affiliations
- Sarah Cannon (US)
- Erasmus MC (NL)
- Henry Dunant Hospital (GR)
- Kantonsspital Winterthur (CH)
- University Hospital Cologne (DE)
- The University of Texas MD Anderson Cancer Center (US)
- Kyushu University Hospital (JP)
- Asan Medical Center (KR)
- Metropolitan Hospital (GR)
- Ospedale San Luigi Gonzaga (IT)
- Centre Hospitalier Universitaire Vaudois (CH)
- Vall d'Hebron Hospital Universitari (ES)
- Peter MacCallum Cancer Centre (AU)
- Emory University (US)
- KU Leuven (BE)
- University of Manchester (GB)
- Centre Hospitalier de l’Université de Montréal (CA)
- Amgen (United States) (US)
- Amgen (Switzerland) (CH)
- Oncology Hematology Care (US)
- Universidad Complutense de Madrid (ES)
- Corresponding author
- Paz-Ares, Luis
- ORCID
- Johnson, Melissa L
- Dingemans, Anne-Marie C
- Mountzios, Giannis
- Pless, Miklos
- Wolf, Jürgen
- Skoulidis, Ferdinandos
- Yoneshima, Yasuto
- Kim, Sang-We
- Linardou, Helena
- Novello, Silvia
- Chen, Yuanbin
- Peters, Solange
- Felip, Enriqueta
- Solomon, Benjamin J
- Ramalingam, Suresh S.
- Dooms, Christophe
- Lindsay, Colin R
- Ferreira, Carlos Gil
- Blais, Normand
- Wang, Yang
- Stollenwerk, Björn
- Waterhouse, David
- Paz-Ares, Luis
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2023-03
- Volume
- 401
- Issue
- 10378
- Pages
- 733-746
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W4319337483
- Cited by
- 619
- References
- 29
- Citations by year
- 2026: 146 · 2025: 196 · 2024: 196 · 2023: 81
- FWCI
- 113.31
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (publishedVersion, other-oa)
- Institutional Research Information System University of Turin (University of Turin) (submittedVersion, other-oa)
- EUR Research Repository (Erasmus University Rotterdam) (submittedVersion)
- HAL (submittedVersion)
- IRIS (submittedVersion)
- Lirias (KU Leuven) (submittedVersion)
- Research Explorer (The University of Manchester) (submittedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, other-oa)
- SERVAL (Université de Lausanne) (submittedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion)
- Funders
- Amgen
- Amgen Inc San Francisco
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
- Keywords
- sotorasib, docetaxel, KRAS G12C mutation, non-small cell lung cancer, KRAS inhibitors, progression-free survival, second-line therapy, previously treated advanced NSCLC, central nervous system metastasis, treatment safety, oral versus intravenous administration, head-to-head comparison
- MeSH terms
- Docetaxel, Adolescent, Adult, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Humans, Lung Neoplasms, Mutation, Piperazines, Pyridines, Pyrimidines, Proto-Oncogene Proteins p21(ras), Disease-Free Survival
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