Sotorasib (AMG 510) in Subjects with NSCLC with KRASG12C Mutation in Need of First-Line Treatment

Phase 1

• Conditions: on-small cell lung cancer (NSCLC); MedDRA version: 21.1Level: PTClassification code: 10029522Term: Non-small cell lung cancer stage IV Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2024-511189-36-00
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-19
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

Adult 18 years or older with NSCLC, Untreated Stage IV metastatic disease. Participants who received adjubant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed greter than 12 months prior to the deveolpment of metastatic disease, Pathologically documented metastatic NSCLC with KRAS G12C mutation (local confirmation), Programmed death-ligand 1 (PD0L1) TPS Score less than 1 percent and or serine threonine kinase 11 (STK11) co-mutation (local confirmation), Eastern Cooperatiove Oncology Group (ECOG) score of 0 or 1, No active brain metastases, ?Measurable disease per investigator interpretation using 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, Use of proton-pump inhibitors (PPIs), histamine (H2) receptor antagonistes (H2RA), strong inducers of cytochrome P450 (CYP) 3A4 (CYP3A4) or known CYP3A4 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 tomorgraphy (CT) scans and gadolinium contrast for magnetic resonance imagine (MRI) scans, Myocardial infarction within 6 months of study day 1

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified