Trial results for sotorasib (NCT04933695) were posted on 2026-07-13, detailing findings from a PHASE2 study in participants with Stage IV non-small cell lung cancer (NSCLC) harboring a KRAS p.G12C mutation. The trial reported an objective response rate (ORR) of 26.8 percentage of participants and a median overall survival (OS) of 11.8 months. The study was subsequently recorded as TERMINATED after enrolling 42 participants.

Background

Sotorasib was investigated as a first-line treatment for participants with Stage IV NSCLC whose tumors harbored a KRAS p.G12C mutation. The study focused on evaluating tumor response in specific subgroups, including those with programmed death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) < 1% and/or a serine/threonine kinase 11 (STK11) co-mutation.

Trial design

The study, identified as NCT04933695, was a PHASE2 trial that enrolled 42 participants. It focused on patients with Non-small Cell Lung Cancer, specifically Stage IV NSCLC with a KRAS p.G12C mutation in need of first-line treatment. The intervention involved administering sotorasib at either 960 mg daily or 240 mg daily. The main objective was to evaluate the tumor objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.

Key results

For the sotorasib arm, the objective response rate (ORR) per RECIST 1.1, as assessed by Blinded Independent Central Review (BICR), was 26.8 percentage of participants. The disease control rate (DCR) was 73.2 percentage of participants. The median duration of response (DOR) was 7.2 months, and the median time to response (TTR) was 1.5 months. Median progression-free survival (PFS) was reported as 4.5 months, and median overall survival (OS) was 11.8 months.

Regarding safety, 19 count of participants in the sotorasib 240 mg group and 21 count of participants in the sotorasib 960 mg group experienced treatment-emergent adverse events (TEAEs). Treatment-related TEAEs were reported in 13 count of participants in the sotorasib 240 mg group and 11 count of participants in the sotorasib 960 mg group.

Plasma concentration of sotorasib for the 240 mg QD group showed a mean of 0.00 ng/mL with a standard deviation of 0.00, and for the 960 mg QD group, a mean of 0.00 ng/mL with a standard deviation of 0.00.

What this means

The reported results from this PHASE2 trial provide data on the efficacy and safety profile of sotorasib in a specific population of NSCLC patients. The objective response rate and overall survival figures offer insights into the drug's activity as a first-line treatment. While the trial was recorded as TERMINATED, these posted results contribute to the understanding of sotorasib's potential in treating KRAS p.G12C-mutated Stage IV NSCLC.

Source

This information was sourced from ClinicalTrials.gov, documenting the results posting for trial NCT04933695 on 2026-07-13. The study details are available on clinicaltrials.gov.