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
- Registration Number
- NCT04933695
- Lead Sponsor
- Amgen
- Brief Summary
The main objective of this study is to evaluate the tumor objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in participants who receive sotorasib at either 960 mg daily or 240 mg daily 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 participants with PD-L1 \< 1% and in a subgroup of participants with STK11 co-mutation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- Adult (= or > 18 years old) with NSCLC
- Untreated Stage IV metastatic disease. Participants who received adjuvant or neoadjuvant anti-tumor therapy are eligible if the adjuvant/neoadjuvant therapy was completed greater than 12 months prior to the development of metastatic stage IV 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
- Mixed small-cell lung cancer and NSCLC histology
- 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
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sotorasib: 240 mg Daily Sotorasib Participants with metastatic non-small cell lung cancer (NSCLC) with Kirsten rat sarcoma (KRAS) p.G12C mutation whose tumors express \< 1% programmed death-ligand 1 (PD-L1) and/or serine/threonine kinase 11 (STK11) mutation in need of first line treatment will be administered sotorasib 240 mg daily. Participants will be stratified by known presence of STK11 mutation. Sotorasib: 960 mg Daily Sotorasib Participants with metastatic non-small cell lung cancer (NSCLC) with Kirsten rat sarcoma (KRAS) p.G12C mutation whose tumors express \< 1% programmed death-ligand 1 (PD-L1) and/or serine/threonine kinase 11 (STK11) mutation in need of first line treatment will be administered sotorasib 960 mg daily. Participants will be stratified by known presence of STK11 mutation.
- Primary Outcome Measures
Name Time Method Objective Response Rate (OR) Up to 6 years OR is defined as the total of Complete Response (CR) and Partial Response (PR).
- Secondary Outcome Measures
Name Time Method Number of Participants with a Treatment-emergent Adverse Event (TEAE) Day 1 up to Month 13 Number of Participants with a Treatment-related Adverse Event Day 1 up to Month 13 Number of Participants with a Clinically Significant Change from Baseline in Vital Signs Baseline (Screening; up to 28 days pre-dose) up to Month 13 Disease Control Rate Up to 6 years Duration of Reponse (DOR) Up to 6 years Time to Response (TTR) Up to 6 years Number of Participants with a Clinically Significant Change from Baseline in Electrocardiograms (ECGs) Baseline (Screening; up to 28 days pre-dose) up to Month 13 Number of Participants with a Clinically Significant Change from Baseline in Clinical Laboratory Tests Baseline (Screening; up to 28 days pre-dose) up to Month 13 Maximum Plasma Concentration (Cmax) of Sotorasib Day 1 up to Month 3 Time to Reach Maximum Plasma Concentration (tmax) of Sotorasib Day 1 up to Month 3 Area Under the Plasma Concentration-time Curve (AUC) of Sotorasib Day 1 up to Month 3 Progression-free Survival (PFS) Up to 6 years Overall Survival (OS) Up to 6 years
Trial Locations
- Locations (67)
Alabama Oncology
🇺🇸Birmingham, Alabama, United States
Arizona Oncology Associates Professional Corporation
🇺🇸Tucson, Arizona, United States
City of Hope at Long Beach Elm
🇺🇸Duarte, California, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
Baptist MD Anderson Cancer Center
🇺🇸Jacksonville, Florida, United States
Northwest Georgia Oncology Centers PC
🇺🇸Marietta, Georgia, United States
Indiana University Melvin and Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
Frederick Memorial Hospital
🇺🇸Frederick, Maryland, United States
Englewood Hospital and Medical Center
🇺🇸Englewood, New Jersey, United States
Scroll for more (57 remaining)Alabama Oncology🇺🇸Birmingham, Alabama, United States