{"entity":{"id":"kras-g12c-nsclc","kind":"cancer","name":"KRAS G12C-mutant non-small-cell lung cancer","aka":["KRAS G12C lung cancer","KRAS-mutant NSCLC","KRAS p.G12C non-small-cell lung cancer"],"tldr":"KRAS G12C lung cancer carries a mutation that was thought impossible to drug for forty years. Sotorasib and adagrasib now shrink about four in ten tumours after chemotherapy and immunotherapy, though the benefit is measured in months, and newer inhibitors and first-line combinations with immunotherapy are in trials.","summary":"KRAS was the first human oncogene identified in a solid tumour, but its smooth surface and picomolar affinity for GTP defeated every attempt at a drug until 2013, when Kevan Shokat's laboratory showed that the mutant cysteine of G12C could be trapped by a covalent inhibitor in a pocket that exists only in the inactive, GDP-bound state. Unlike EGFR or ALK disease, KRAS-mutant lung cancer occurs in smokers, carries a high mutation burden, often expresses PD-L1 and responds to checkpoint inhibitors, so first-line treatment is chemoimmunotherapy or pembrolizumab alone as for driver-negative disease; co-mutations in STK11 and KEAP1, present in a quarter to a third, blunt that response.\n\nSotorasib produced a 37 percent response rate in previously treated patients in CodeBreaK 100 and received accelerated approval in May 2021, the first KRAS inhibitor; CodeBreaK 200 (2023) then showed it beat docetaxel on progression-free survival (5.6 versus 4.5 months, hazard ratio 0.66) but not overall survival, and the FDA required a new dose-comparison study. Adagrasib produced a 43 percent response rate in KRYSTAL-1 with activity in brain metastases and was approved in December 2022; KRYSTAL-12 (2024) showed progression-free survival of 5.5 versus 3.8 months against docetaxel (hazard ratio 0.58). Resistance emerges within months through secondary KRAS mutations, amplification, bypass through receptor tyrosine kinases and histological transformation, and both drugs have liver toxicity that is worse soon after immunotherapy.\n\nThe field is moving in three directions: more potent or better tolerated G12C inhibitors (divarasib, with a 53 percent response rate in phase 1 and the Krascendo 1 phase 3; olomorasib; glecirasib and garsorasib approved in China), first-line combinations with pembrolizumab (KRYSTAL-7, SUNRAY-01), and pan-RAS inhibitors such as daraxonrasib that bind the active state. Open questions are why lung tumours respond better than colorectal tumours, how to overcome STK11 and KEAP1 co-mutations, and whether a KRAS inhibitor can be combined safely with a checkpoint inhibitor from the start.","asOf":"2026-09-17","wikipedia":"https://en.wikipedia.org/wiki/KRAS","links":[{"label":"Wikipedia","url":"https://en.wikipedia.org/wiki/KRAS"},{"label":"NCCN Guidelines: Non-Small Cell Lung Cancer","url":"https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1450"}],"tags":["subtype-page","lung"],"related":["egfr-mutant-nsclc","alk-positive-nsclc","braf-v600e-nsclc","her2-mutant-nsclc","pdl1-high-nsclc","met-altered-nsclc"],"cancers":[],"sections":[],"technologies":["kras-inhibitors","kinase-inhibitors","checkpoint-inhibitor","liquid-biopsy","cgp"],"targets":["kras","pd1","pdl1"],"drugs":["sotorasib","adagrasib","divarasib","olomorasib","glecirasib","garsorasib","daraxonrasib","calderasib","pembrolizumab","docetaxel"],"companies":["amgen","bms","roche-genentech","eli-lilly","merck"],"institutions":[],"pathways":["ras-mapk","nsclc-signalling","pd1-checkpoint"],"terms":["kras-mutation-subtypes","driver-mutation","resistance","hepatotoxicity","brain-metastases","tps"],"trials":["codebreak-200","krystal-12","krascendo-1","nct06119581","nct04613596","nct07190248"],"people":["kevan-shokat","ferdinandos-skoulidis","pasi-janne","tony-mok","ramaswamy-govindan"],"bottlenecks":[],"keyPapers":["paper-ostrem-kras-g12c-nature-2013","paper-codebreak-200-lancet-2023"],"journals":[],"dependsOn":[],"notes":[],"group":"lung","burden":"KRAS is mutated in about a quarter of lung adenocarcinomas in Europe and North America, and G12C, the smoking-associated variant, accounts for about 13 percent of adenocarcinomas, making it the single commonest targetable driver in Western patients. It is rarer in East Asia.","subtypes":["KRAS G12C adenocarcinoma with high PD-L1 (chemoimmunotherapy or pembrolizumab first, inhibitor second)","KRAS G12C adenocarcinoma with STK11 or KEAP1 co-mutation (poor immunotherapy response)","KRAS G12C with brain metastases (adagrasib has intracranial activity)","Non-G12C KRAS mutations (G12D, G12V; pan-RAS inhibitors in trials)"],"biomarkers":["KRAS G12C by tissue or plasma sequencing","PD-L1 tumour proportion score (first-line choice)","STK11 and KEAP1 co-mutations (prognostic, immunotherapy resistance)","TP53 co-mutation","Acquired KRAS mutations, MET amplification or bypass alterations at progression","Liver enzymes on a G12C inhibitor, especially soon after immunotherapy"],"standardOfCare":[{"setting":"Advanced, first line","approach":"As for driver-negative disease: pembrolizumab plus platinum doublet, or pembrolizumab alone if PD-L1 is 50 percent or more; KRAS inhibitors are not yet approved first line.","refs":["pembrolizumab","keynote-024-189","carboplatin","pemetrexed","paclitaxel","tps"],"guideline":{"version":"NCCN Guidelines: Non-Small Cell Lung Cancer","url":"https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1450"}},{"setting":"Advanced, after chemoimmunotherapy","approach":"Sotorasib (CodeBreaK 200) or adagrasib (KRYSTAL-12), preferred to docetaxel; adagrasib for active brain metastases; docetaxel with or without ramucirumab afterwards.","refs":["sotorasib","codebreak-200","adagrasib","krystal-12","docetaxel","ramucirumab","kras-inhibitors"],"guideline":{"version":"NCCN Guidelines: Non-Small Cell Lung Cancer","url":"https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1450"}},{"setting":"Advanced, clinical trials","approach":"Divarasib versus sotorasib or adagrasib (Krascendo 1); olomorasib or adagrasib with pembrolizumab first line (SUNRAY-01, KRYSTAL-7); pan-RAS inhibitors.","refs":["divarasib","krascendo-1","olomorasib","nct06119581","nct04613596","daraxonrasib"],"guideline":{"version":"NCCN Guidelines: Non-Small Cell Lung Cancer","url":"https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1450"}}],"stateOfArt":["Two approved covalent G12C inhibitors after chemoimmunotherapy, both with progression-free survival gains over docetaxel of one to two months and response rates around 40 percent.","Divarasib, olomorasib and the Chinese inhibitors glecirasib and garsorasib aim at deeper and longer responses.","First-line KRAS inhibitor plus pembrolizumab combinations in phase 3.","Pan-RAS and RAS(ON) inhibitors extend the approach to G12D and G12V."],"history":[{"year":1982,"title":"KRAS identified as a human oncogene in lung cancer cell lines","refs":["kras","oncogene"]},{"year":2013,"title":"Ostrem and Shokat trap mutant G12C cysteine in the switch-II pocket","refs":["kevan-shokat","kras","paper-ostrem-kras-g12c-nature-2013"]},{"year":2021,"title":"Sotorasib approved after CodeBreaK 100: the first KRAS inhibitor","refs":["sotorasib","ferdinandos-skoulidis","amgen"]},{"year":2022,"title":"Adagrasib approved after KRYSTAL-1, with brain activity","refs":["adagrasib","pasi-janne"]},{"year":2023,"title":"CodeBreaK 200: sotorasib beats docetaxel on progression-free but not overall survival","refs":["codebreak-200","sotorasib","paper-codebreak-200-lancet-2023"]},{"year":2024,"title":"KRYSTAL-12: adagrasib beats docetaxel; divarasib enters phase 3 (Krascendo 1)","refs":["krystal-12","adagrasib","divarasib","krascendo-1"]}],"pipeline":["divarasib","krascendo-1","olomorasib","nct06119581","nct04613596","glecirasib","garsorasib","daraxonrasib","calderasib","nct07190248","idea-bio1-pmhc-bispecifics-public-drivers","idea-shared-kras-vaccine-adjuvant"],"openProblems":["Responses to G12C inhibitors are shallower and shorter in lung cancer than EGFR or ALK inhibitors achieve, and no overall survival benefit over docetaxel has been shown.","Liver toxicity when a G12C inhibitor follows or accompanies a checkpoint inhibitor limits first-line combinations.","STK11 and KEAP1 co-mutations predict poor outcome with every treatment and have no targeted therapy.","Resistance is polyclonal and mechanistically diverse, arguing for combinations from the start."],"parent":"nsclc"},"route":"/cancers/kras-g12c-nsclc/","neighbours":{"cancer":[{"id":"lung-adenocarcinoma","kind":"cancer","name":"Adenocarcinoma of the lung","route":"/cancers/lung-adenocarcinoma/"},{"id":"alk-positive-nsclc","kind":"cancer","name":"ALK-positive non-small-cell lung cancer","route":"/cancers/alk-positive-nsclc/"},{"id":"braf-v600e-nsclc","kind":"cancer","name":"BRAF V600E-mutant non-small-cell lung cancer","route":"/cancers/braf-v600e-nsclc/"},{"id":"egfr-mutant-nsclc","kind":"cancer","name":"EGFR-mutated non-small-cell lung cancer","route":"/cancers/egfr-mutant-nsclc/"},{"id":"her2-mutant-nsclc","kind":"cancer","name":"HER2-mutant non-small-cell lung cancer","route":"/cancers/her2-mutant-nsclc/"},{"id":"invasive-mucinous-adenocarcinoma-lung","kind":"cancer","name":"Invasive mucinous adenocarcinoma of the lung","route":"/cancers/invasive-mucinous-adenocarcinoma-lung/"},{"id":"kras-g12c-pdac","kind":"cancer","name":"KRAS G12C-mutant pancreatic ductal adenocarcinoma","route":"/cancers/kras-g12c-pdac/"},{"id":"met-altered-nsclc","kind":"cancer","name":"MET exon 14 and MET-amplified non-small-cell lung cancer","route":"/cancers/met-altered-nsclc/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"pdl1-high-nsclc","kind":"cancer","name":"PD-L1-high non-small-cell lung cancer without a driver mutation","route":"/cancers/pdl1-high-nsclc/"}],"technology":[{"id":"cgp","kind":"technology","name":"Comprehensive genomic profiling","route":"/technologies/cgp/"},{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"},{"id":"kras-inhibitors","kind":"technology","name":"KRAS & RAS inhibitors","route":"/technologies/kras-inhibitors/"},{"id":"liquid-biopsy","kind":"technology","name":"Liquid biopsy (ctDNA)","route":"/technologies/liquid-biopsy/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"kras","kind":"target","name":"KRAS","route":"/targets/kras/"},{"id":"pd1","kind":"target","name":"PD-1","route":"/targets/pd1/"},{"id":"pdl1","kind":"target","name":"PD-L1","route":"/targets/pdl1/"}],"drug":[{"id":"adagrasib","kind":"drug","name":"Adagrasib","route":"/drugs/adagrasib/"},{"id":"calderasib","kind":"drug","name":"Calderasib","route":"/drugs/calderasib/"},{"id":"carboplatin","kind":"drug","name":"Carboplatin","route":"/drugs/carboplatin/"},{"id":"daraxonrasib","kind":"drug","name":"Daraxonrasib","route":"/drugs/daraxonrasib/"},{"id":"divarasib","kind":"drug","name":"Divarasib","route":"/drugs/divarasib/"},{"id":"docetaxel","kind":"drug","name":"Docetaxel","route":"/drugs/docetaxel/"},{"id":"garsorasib","kind":"drug","name":"Garsorasib","route":"/drugs/garsorasib/"},{"id":"glecirasib","kind":"drug","name":"Glecirasib","route":"/drugs/glecirasib/"},{"id":"olomorasib","kind":"drug","name":"Olomorasib","route":"/drugs/olomorasib/"},{"id":"paclitaxel","kind":"drug","name":"Paclitaxel / nab-paclitaxel","route":"/drugs/paclitaxel/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"},{"id":"pemetrexed","kind":"drug","name":"Pemetrexed","route":"/drugs/pemetrexed/"},{"id":"ramucirumab","kind":"drug","name":"Ramucirumab","route":"/drugs/ramucirumab/"},{"id":"sotorasib","kind":"drug","name":"Sotorasib","route":"/drugs/sotorasib/"}],"company":[{"id":"amgen","kind":"company","name":"Amgen","route":"/companies/amgen/"},{"id":"bms","kind":"company","name":"Bristol Myers Squibb","route":"/companies/bms/"},{"id":"eli-lilly","kind":"company","name":"Eli Lilly (incl. Loxo)","route":"/companies/eli-lilly/"},{"id":"merck","kind":"company","name":"Merck & Co. (MSD)","route":"/companies/merck/"},{"id":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"pathway":[{"id":"nsclc-signalling","kind":"pathway","name":"Non-small cell lung cancer (KEGG map)","route":"/pathways/nsclc-signalling/"},{"id":"pd1-checkpoint","kind":"pathway","name":"PD-1 / PD-L1 immune checkpoint & T-cell activation","route":"/pathways/pd1-checkpoint/"},{"id":"ras-mapk","kind":"pathway","name":"RAS / RAF / MEK / ERK (MAPK)","route":"/pathways/ras-mapk/"}],"term":[{"id":"brain-metastases","kind":"term","name":"Brain metastases (intracranial disease)","route":"/terms/brain-metastases/"},{"id":"driver-mutation","kind":"term","name":"Driver mutation","route":"/terms/driver-mutation/"},{"id":"resistance","kind":"term","name":"Drug resistance (primary and acquired)","route":"/terms/resistance/"},{"id":"hepatotoxicity","kind":"term","name":"Hepatotoxicity (liver enzyme elevation)","route":"/terms/hepatotoxicity/"},{"id":"kras-mutation-subtypes","kind":"term","name":"KRAS mutation subtypes (G12C, G12D, G12V)","route":"/terms/kras-mutation-subtypes/"},{"id":"oncogene","kind":"term","name":"Oncogene","route":"/terms/oncogene/"},{"id":"tps","kind":"term","name":"Tumour proportion score (TPS)","route":"/terms/tps/"}],"trial":[{"id":"nct07190248","kind":"trial","name":"A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)","route":"/trials/nct07190248/"},{"id":"nct07554339","kind":"trial","name":"A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015)","route":"/trials/nct07554339/"},{"id":"nct06936644","kind":"trial","name":"A Multicenter, Single-arm Phase II Study to Evaluate the Efficacy and Safety of Fulzerasib (IBI351) in Combination With Ivonescimab (AK-112) in First-line Treatment of Advanced or Metastatic Non-small Cell Lung Cancer Patients With KRAS G12C Mutation","route":"/trials/nct06936644/"},{"id":"nct07164170","kind":"trial","name":"A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Glecirasib","route":"/trials/nct07164170/"},{"id":"nct07174908","kind":"trial","name":"A Phase 3 Study of IN10018 in Combination With D-1553 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation","route":"/trials/nct07174908/"},{"id":"nct07833202","kind":"trial","name":"A Phase 3 Study of Sosimerasib in Combination With IN10018 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutatio","route":"/trials/nct07833202/"},{"id":"nct06244771","kind":"trial","name":"A Study Evaluating FMC-376 in Participants With KRAS G12C Mutated Solid Tumors","route":"/trials/nct06244771/"},{"id":"nct07822542","kind":"trial","name":"A Study Evaluating HS-10370 Plus Platinum-based Doublet Chemotherapy With or 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KRAS G12C Mutant Solid Tumors","route":"/trials/nct06128551/"},{"id":"nct05132075","kind":"trial","name":"Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer","route":"/trials/nct05132075/"},{"id":"nct04699188","kind":"trial","name":"Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation","route":"/trials/nct04699188/"},{"id":"nct04956640","kind":"trial","name":"Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)","route":"/trials/nct04956640/"},{"id":"nct06890598","kind":"trial","name":"Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer","route":"/trials/nct06890598/"},{"id":"nct04585035","kind":"trial","name":"Study to Evaluate D-1553 in Subjects With Solid Tumors","route":"/trials/nct04585035/"}],"person":[{"id":"ferdinandos-skoulidis","kind":"person","name":"Ferdinandos Skoulidis","route":"/people/ferdinandos-skoulidis/"},{"id":"gary-middleton","kind":"person","name":"Gary Middleton","route":"/people/gary-middleton/"},{"id":"kevan-shokat","kind":"person","name":"Kevan M. Shokat","route":"/people/kevan-shokat/"},{"id":"pasi-janne","kind":"person","name":"Pasi A. Jänne","route":"/people/pasi-janne/"},{"id":"ramaswamy-govindan","kind":"person","name":"Ramaswamy Govindan","route":"/people/ramaswamy-govindan/"},{"id":"tony-mok","kind":"person","name":"Tony S. K. Mok","route":"/people/tony-mok/"}],"paper":[{"id":"paper-codebreak-200-lancet-2023","kind":"paper","name":"CodeBreaK 200: sotorasib versus docetaxel in KRAS G12C-mutated lung cancer, a modest win for the first KRAS drug","route":"/key-papers/paper-codebreak-200-lancet-2023/"},{"id":"paper-krystal-12-plain-language-summary-future-oncol-2026","kind":"paper","name":"KRYSTAL-12 plain language summary: adagrasib for non-small-cell lung cancer with KRAS G12C mutations","route":"/key-papers/paper-krystal-12-plain-language-summary-future-oncol-2026/"},{"id":"paper-ostrem-kras-g12c-nature-2013","kind":"paper","name":"Ostrem and Shokat: the hidden pocket that made KRAS G12C druggable","route":"/key-papers/paper-ostrem-kras-g12c-nature-2013/"}],"idea":[{"id":"idea-bio1-pmhc-bispecifics-public-drivers","kind":"idea","name":"Antibodies that see mutant KRAS and p53 fragments displayed on the cell surface","route":"/ideas/idea-bio1-pmhc-bispecifics-public-drivers/"},{"id":"idea-shared-kras-vaccine-adjuvant","kind":"idea","name":"Off-the-shelf KRAS vaccines after pancreatic cancer surgery","route":"/ideas/idea-shared-kras-vaccine-adjuvant/"}]}}