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Sotorasib
Source: Non-Small Cell Lung Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: May 15, 2025 · Captured 2026-09-09.
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Evidence (sotorasib):
A phase II clinical trial (CodeBreaK 100 [NCT03600883]) evaluated sotorasib (960 mg orally once daily) in patients with KRAS G12C variants who were previously treated with standard therapies. A total of 126 patients were enrolled. Of 124 evaluable patients, most (81%) received prior platinum-based therapy and inhibitors of PD-1 or PD-L1. The primary end point was overall response according to independent central review.[57][Level of evidence C3]
Source links and citations
A phase II clinical trial (CodeBreaK 100 [NCT03600883]) evaluated sotorasib (960 mg orally once daily) in patients with KRAS G12C variants who were previously treated with standard therapies. A total of 126 patients were enrolled. Of 124 evaluable patients, most (81%) received prior platinum-based therapy and inhibitors of PD-1 or PD-L1. The primary end point was overall response according to independent central review.[57][Level of evidence C3]
For the 124 evaluable patients, the overall response rate was 37.1% (95% CI, 28.6%–46.2%), including complete responses in 3.2%. The median DOR was 11.1 months (95% CI, 6.9–could not be evaluated). Disease control occurred in 80.6% of patients (95% CI, 72.6%–87.2%).
A phase II clinical trial (CodeBreaK 100 [NCT03600883]) evaluated sotorasib (960 mg orally once daily) in patients with KRAS G12C variants who were previously treated with standard therapies. A total of 126 patients were enrolled. Of 124 evaluable patients, most (81%) received prior platinum-based therapy and inhibitors of PD-1 or PD-L1. The primary end point was overall response according to independent central review.[57][Level of evidence C3]
Median PFS was 6.8 months (95% CI, 5.1–8.2) and median OS was 12.5 months (95% CI, 10.0–could not be evaluated).
A phase II clinical trial (CodeBreaK 100 [NCT03600883]) evaluated sotorasib (960 mg orally once daily) in patients with KRAS G12C variants who were previously treated with standard therapies. A total of 126 patients were enrolled. Of 124 evaluable patients, most (81%) received prior platinum-based therapy and inhibitors of PD-1 or PD-L1. The primary end point was overall response according to independent central review.[57][Level of evidence C3]
Grade 3 to 4 adverse events occurred in 20.6% of patients. The most common adverse events that were considered treatment related were diarrhea, nausea, increases in ALT or AST, and fatigue. Adverse events led to therapy discontinuation in 7.1% of patients.
The FDA approved sotorasib for the treatment of adult patients with locally advanced or metastatic NSCLC and KRAS G12C variants, as determined by an FDA-approved test, who have received at least one prior systemic therapy.
Studies cited in this source section
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Preserved source evidence · Not medical advice