Therapy Detail
Contact
Missing content? – Request curation!
Request curation for specific Genes, Variants, or PubMed publications.
Have questions, comments, or suggestions? - Let us know!
Email us at : ckbsupport@genomenon.com
| 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). |
Filtering
- Case insensitive filtering will display rows if any text in any cell matches the filter term
- Use simple literal full or partial string matches
- Separate multiple filter terms with a space. Any order may be used (i. e. a b c and c b a are equivalent )
- Filtering will only apply to rows that are already loaded on the page. Filtering has no impact on query parameters.
- Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")
Sorting
- Generally, the default sort order for tables is set to be first column ascending; however, specific tables may set a different default sort order.
- Click on any column header arrows to sort by that column
- Hold down the Shift key and click multiple columns to sort by more than one column. Be sure to set ascending or descending order for a given column before moving on to the next column.
| 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, and in combination with Vectibix (panitumumab) in patients with metastatic colorectal cancer harboring KRAS G12C who have received chemotherapy (FDA.gov). |
Filtering
- Case insensitive filtering will display rows if any text in any cell matches the filter term
- Use simple literal full or partial string matches
- Separate multiple filter terms with a space. Any order may be used (i. e. a b c and c b a are equivalent )
- Filtering will only apply to rows that are already loaded on the page. Filtering has no impact on query parameters.
- Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")
Sorting
- Generally, the default sort order for tables is set to be first column ascending; however, specific tables may set a different default sort order.
- Click on any column header arrows to sort by that column
- Hold down the Shift key and click multiple columns to sort by more than one column. Be sure to set ascending or descending order for a given column before moving on to the next column.
| 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 |
Filtering
- Case insensitive filtering will display rows if any text in any cell matches the filter term
- Use simple literal full or partial string matches
- Separate multiple filter terms with a space. Any order may be used (i. e. a b c and c b a are equivalent )
- Filtering will only apply to rows that are already loaded on the page. Filtering has no impact on query parameters.
- Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")
Sorting
- Generally, the default sort order for tables is set to be first column ascending; however, specific tables may set a different default sort order.
- Click on any column header arrows to sort by that column
- Hold down the Shift key and click multiple columns to sort by more than one column. Be sure to set ascending or descending order for a given column before moving on to the next column.
| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| NCT06582771 | Phase II | Sotorasib | A Study of Sotorasib in People With Non-Small Cell Lung Cancer | 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) | Recruiting | USA | SWE | POL | NLD | ITA | GRC | GBR | FRA | ESP | DNK | DEU | BRA | BEL | AUT | AUS | ARG | 8 |
| 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 |
| 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 |
| NCT05400577 | Phase II | Sotorasib | Sotorasib in KRAS G12C Mutated, Resectable, Stage Ib-IIIA NSCLC | Withdrawn | USA | 0 |
| NCT04667234 | Expanded access | Sotorasib | Expanded Access of Sotorasib | No longer available | USA | ISR | BRA | ARG | 2 |
| NCT06333678 | Phase II | Durvalumab Sotorasib | A Study Comparing Sotorasib With Durvalumab in People With Non-Small Cell Lung Cancer (NSCLC) | Recruiting | USA | 0 |
| NCT05631249 | Phase II | Sotorasib | Sotorasib in Previously Treated Locally Advanced or Metastatic NSCLC Subjects With Mutated KRAS p.G12C (CODEBREAK-IGR) | Recruiting | FRA | 0 |
| NCT05311709 | Phase II | Sotorasib | Sotorasib in Advanced KRASG12C-mutated Non-small Cell Lung Cancer Patients With Comorbidities (SOLUCOM) | Recruiting | 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) | Recruiting | USA | 0 |
| 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 |
CKB BOOST