Clinical study to investigate the safety, efficacy and pharmacokinetics of sotorasib in Subjects with Non-Small Cell Lung Cancer

Phase 1

• Conditions: KRAS p.G12C mutant untreated stage IV Non-Small Cell Lung Cancer (NSCLC); MedDRA version: 21.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-002638-18-DK
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-10
• Last Update Posted: 9 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 170

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) 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 investigator interpretation using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

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 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 tomography (CT) scans and gadolinium contrast for magnetic resonance imagine (MRI) scans

Study & Design

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