Lumakras fist line for NSCL cancer – pro

Lumakras (sotorasib) is a prescription, once-daily oral tablet (960 mg) used to treat adults with KRAS G12C-mutated, metastatic or locally advanced non-small cell lung cancer (NSCLC) who have received at least one prior therapy. The studies on which FDA approval was based had been in second or later line.
Only preliminary studies in the first line are available. New results from the phase 1b CodeBreaK 101 trial reported at the World Conference on Lung Cancer (WCLC) found that out of 20 patients treated with Lumakras (sotorasib) alongside chemotherapy with carboplatin and pemetrexed first-line, two-thirds of them saw their tumours shrink, giving an objective response rate (ORR) of 65%. The remainder all saw the growth of their tumours stabilise, giving a disease control rate of 100% with the drug.
Amgen has initiated a phase 3 study of sotorasib (Lumakras) plus carboplatin and pemetrexed in the first-line treatment of KRASG12C-mutant advanced non–small cell lung cancer (NSCLC) due to results from the CodeBreaK 101 clinical trial (NCT04185883). Tis drug is still E/I in first line.

https://pharmaphorum.com/news/esmo-amgen-reveals-lumakras-data-as-rival-looms-in-rear-view-mirror, Accessed 2/13/2026.

Nakajima EC, Drezner N, Li X, Mishra-Kalyani PS, Liu Y, Zhao H, Bi Y, Liu J, Rahman A, Wearne E, Ojofeitimi I, Hotaki LT, Spillman D, Pazdur R, Beaver JA, Singh H. FDA Approval Summary: Sotorasib for KRAS G12C-Mutated Metastatic NSCLC. Clin Cancer Res. 2022 Apr 14;28(8):1482-1486. doi: 10.1158/1078-0432.CCR-21-3074. PMID: 34903582; PMCID: PMC9012672.

NCCN NSCL Cancer 2026

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