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

• Status: Not yet recruiting
• Trial end date: 2027-12-22
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of this study is to evaluate the tumor objective response rate (ORR) of sotorasib assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria in participants who receive sotorasib at either Dose A or a Dose B whose tumors are programmed death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) < 1% and/or harbor a serine/threonine kinase 11 (STK11) co-mutation, in a subgroup of subjects with PD-L1 < 1% and in a subgroup of subjects with STK11 co-mutation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen

Criteria

Inclusion Criteria:

• Adult (= or > 18 years old) with NSCLC

• Untreated Stage IV metastatic disease. Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed greater than 12 months prior to the development of metastatic disease

• Pathologically documented metastatic NSCLC with KRAS G12C mutation (local confirmation)

• Programmed death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) Score < 1% and/or serine/threonine kinase 11 (STK11) co-mutation (local confirmation)

• Eastern Cooperative Oncology Group (ECOG) score of 0 or 1

• No active brain metastases

• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

Exclusion Criteria:

• Mixed small-cell lung cancer and NSCLC histology

• Active brain metastases from non-brain tumors

• Myocardial Infarction within 6 months of study Day 1

• Use of proton-pump inhibitors (PPIs), histamine (H2) receptor antagonists (H2RA), strong inducers of CYP3A4 or known cytochrome P450 (CYP) 3A4 sensitive substrates or P-gp substrates

• Therapeutic or palliative radiation therapy within 2 weeks of study day 1

• Unable to take oral medication

• Unable to receive both iodinated contrast for computed tomography (CT) scans and gadolinium contrast for magnetic resonance imagine (MRI) scans