Therapy Detail
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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 (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 34 | 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 (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| 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 |
| 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 | 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 |
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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) | Recruiting | USA | NLD | ITA | GBR | ESP | DEU | CAN | BEL | AUT | AUS | 3 |
| 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) | Recruiting | USA | 1 |
| NCT06333678 | Phase II | Durvalumab Sotorasib | A Study Comparing Sotorasib With Durvalumab in People With Non-Small Cell Lung Cancer (NSCLC) | Recruiting | USA | 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 |
| 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 |
| NCT05631249 | Phase II | Sotorasib | Sotorasib in Previously Treated Locally Advanced or Metastatic NSCLC Subjects With Mutated KRAS p.G12C (CODEBREAK-IGR) | Recruiting | FRA | 0 |
| 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) | Active, not recruiting | USA | TUR | SWE | NLD | ITA | FRA | ESP | DNK | DEU | BEL | 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) | Recruiting | USA | SWE | POL | ITA | GBR | FRA | DNK | DEU | BRA | AUS | ARG | 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) | Recruiting | USA | 0 |
| NCT06582771 | Phase II | Sotorasib | A Study of Sotorasib in People With Non-Small Cell Lung Cancer | Recruiting | USA | 0 |
| NCT05400577 | Phase II | Sotorasib | Sotorasib in KRAS G12C Mutated, Resectable, Stage Ib-IIIA NSCLC | Withdrawn | USA | 0 |
| NCT05311709 | Phase II | Sotorasib | Sotorasib in Advanced KRASG12C-mutated Non-small Cell Lung Cancer Patients With Comorbidities (SOLUCOM) | Recruiting | NOR | 0 |
| 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 |
| NCT04667234 | Expanded access | Sotorasib | Expanded Access of Sotorasib | No longer available | USA | ISR | BRA | ARG | 2 |
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