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Therapy Name Sotorasib
Synonyms
Therapy Description

Lumakras (sotorasib) is small molecule inhibitor that selectively targets KRAS G12C and inhibits downstream signaling, which may lead to growth inhibition of tumors harboring KRAS G12C (PMID: 31666701). Lumakras (sotorasib) is FDA approved for use in patients with locally advanced or metastatic non-small cell lung cancer harboring KRAS G12C who have received one or more prior therapy, and in combination with Vectibix (panitumumab) in patients with metastatic colorectal cancer harboring KRAS G12C who have received chemotherapy (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Sotorasib Lumakras AMG 510|AMG510|AMG-510|Lumykras KRAS G12C inhibitor 36 Lumakras (sotorasib) is small molecule inhibitor that selectively targets KRAS G12C and inhibits downstream signaling, which may lead to growth inhibition of tumors harboring KRAS G12C (PMID: 31666701). Lumakras (sotorasib) is FDA approved for use in patients with locally advanced or metastatic non-small cell lung cancer harboring KRAS G12C who have received one or more prior therapy, and in combination with Vectibix (panitumumab) in patients with metastatic colorectal cancer harboring KRAS G12C who have received chemotherapy (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
HRAS G12C Advanced Solid Tumor sensitive Sotorasib Preclinical - Cell culture Actionable In a preclinical study, Lumakras (sotorasib) inhibited Erk1/2 phosphorylation and viability in cells expressing HRAS G12C in culture (PMID: 41340466). 41340466
HRAS G12C Advanced Solid Tumor sensitive Sotorasib Preclinical - Cell culture Actionable In a preclinical study, Lumakras (sotorasib) inhibited viability of cultured cells expressing HRAS G12C (PMID: 38236605). 38236605
HRAS G12C HRAS T58I rhabdomyosarcoma resistant Sotorasib Preclinical - Cell culture Actionable In a preclinical study, a rhabdomyosarcoma cell line harboring HRAS G12C and HRAS T58I was resistant to Lumakras (sotorasib) in culture (PMID: 41340466). 41340466
NRAS G12C acute myeloid leukemia sensitive Sotorasib Preclinical - Cell culture Actionable In a preclinical study, Lumakras (sotorasib) treatment resulted in decreased Erk1/2 phosphorylation, cell cycle arrest, and decreased viability in an acute myeloid leukemia cell line harboring NRAS G12C in culture (PMID: 41340466). 41340466
NRAS G12C Advanced Solid Tumor sensitive Sotorasib Preclinical - Cell culture Actionable In a preclinical study, Lumakras (sotorasib) inhibited Erk1/2 phosphorylation and viability in cells expressing NRAS G12C in culture (PMID: 41340466). 41340466
NRAS G12C Advanced Solid Tumor sensitive Sotorasib Preclinical - Cell culture Actionable In a preclinical study, Lumakras (sotorasib) inhibited viability of cultured cells expressing NRAS G12C (PMID: 38236605). 38236605
HRAS G12C head and neck carcinoma no benefit Sotorasib Preclinical - Cell culture Actionable In a preclinical study, Lumakras (sotorasib) treatment resulted in decreased Erk1/2 phosphorylation at high concentrations, but did not inhibit proliferation in a head and neck carcinoma cell line harboring HRAS G12C in culture (PMID: 41340466). 41340466
NRAS G12C leukemia predicted - sensitive Sotorasib Preclinical - Biochemical Actionable In a preclinical study, Lumakras (sotorasib) inhibited downstream signaling in leukemia cells harboring NRAS G12C in culture (PMID: 38236605). 38236605
MAP2K1 D67N NRAS G12C PTEN del T-cell acute lymphoblastic leukemia no benefit Sotorasib Preclinical - Cell line xenograft Actionable In a preclinical study, Lumakras (sotorasib) treatment resulted in decreased Erk1/2 phosphorylation, but demonstrated only a modest effect on viability in a T-cell acute lymphoblastic leukemia cell line harboring NRAS G12C, MAP2K1 D67N, and PTEN deletion in culture, and inhibited Erk1/2 phosphorylation levels in liver-infiltrating cancer cells but did not prolong survival in a cell line xenograft model (PMID: 41340466). 41340466

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04185883 Phase Ib/II Fluorouracil + Irinotecan + Panitumumab + Sotorasib AMG 404 + Sotorasib Carboplatin + Docetaxel + Paclitaxel + Pembrolizumab + Pemetrexed Disodium + Sotorasib Sotorasib + TNO155 Atezolizumab + Sotorasib Pembrolizumab + Sotorasib Sotorasib Everolimus + Sotorasib Bevacizumab-awwb + Fluorouracil + Oxaliplatin + Sotorasib Bevacizumab-awwb + Fluorouracil + Irinotecan + Sotorasib BI 1701963 + Sotorasib Palbociclib + Sotorasib Afatinib + Sotorasib RMC-4630 + Sotorasib Panitumumab + Sotorasib + Trametinib Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) Active, not recruiting USA | NLD | ITA | GBR | ESP | DEU | CAN | BEL | AUT | AUS 3
NCT05631249 Phase II Sotorasib Sotorasib in Previously Treated Locally Advanced or Metastatic NSCLC Subjects With Mutated KRAS p.G12C (CODEBREAK-IGR) Recruiting FRA 0
NCT05398094 Phase II Sotorasib Clinical Trial of AMG510 in Stage III Unresectable NSCLC KRAS p.G12C Patients and Ineligible for Chemo-radiotherapy (MERIT-lung) Recruiting ESP 0
NCT06333678 Phase II Durvalumab Sotorasib A Study Comparing Sotorasib With Durvalumab in People With Non-Small Cell Lung Cancer (NSCLC) Completed USA 0
NCT04667234 Expanded access Sotorasib Expanded Access of Sotorasib No longer available USA | ISR | BRA | ARG 2
NCT07318389 Phase I Tucatinib Fluorouracil + Irinotecan + Leucovorin Sotorasib Cetuximab Trifluridine-tipiracil hydrochloride Fluorouracil + Leucovorin + Oxaliplatin Adagrasib Encorafenib Trastuzumab deruxtecan Bevacizumab Panitumumab ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer Not yet recruiting USA 0
NCT06497556 Phase III Divarasib Sotorasib Adagrasib 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 (Krascendo 1) Active, not recruiting USA | SWE | POL | NLD | ITA | GRC | GBR | FRA | FIN | ESP | DNK | DEU | CAN | BRA | BEL | AUT | AUS | ARG 8
NCT04303780 Phase III Sotorasib Docetaxel Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200). Active, not recruiting USA | SWE | POL | NLD | ITA | HUN | GRC | GBR | FRA | FIN | ESP | DNK | DEU | CHE | CAN | BRA | BEL | AUS 5
NCT04625647 Phase II Sotorasib Testing the Use of Targeted Treatment (AMG 510) for KRAS G12C Mutated Advanced Non-squamous Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial) Active, not recruiting USA 1
NCT04933695 Phase II Sotorasib 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 (CodeBreaK201) Completed USA | TUR | SWE | NLD | ITA | FRA | ESP | DNK | DEU | BEL 0
NCT05311709 Phase II Sotorasib Sotorasib in Advanced KRASG12C-mutated Non-small Cell Lung Cancer Patients With Comorbidities (SOLUCOM) Unknown status NOR 0
NCT03600883 Phase Ib/II Midazolam + Sotorasib Sotorasib + unspecified PD-1 antibody Sotorasib + unspecified PD-L1 antibody Sotorasib A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100) Active, not recruiting USA | ROU | HUN | GRC | FRA | ESP | DEU | CHE | CAN | BRA | BEL | AUT | AUS 3
NCT05638295 Phase II Sotorasib Panitumumab + Sotorasib Testing the Use of AMG 510 (Sotorasib) and Panitumumab as a Targeted Treatment for KRAS G12C Mutant Solid Tumor Cancers (A ComboMATCH Treatment Trial) Active, not recruiting USA 0
NCT06582771 Phase II Sotorasib A Study of Sotorasib in People With Non-Small Cell Lung Cancer Recruiting USA 0
NCT06807619 Phase I Sotorasib A Study of Sotorasib in People With Brain Tumors Recruiting USA 0
NCT05400577 Phase II Sotorasib Sotorasib in KRAS G12C Mutated, Resectable, Stage Ib-IIIA NSCLC Withdrawn USA 0


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