Description:
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.
Title
- Brief Title: 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
- Official Title: A Phase 2, Multicenter, Open-label Study of Sotorasib (AMG 510) in Subjects With Stage IV NSCLC Whose Tumors Harbor a KRAS G12C Mutation in Need of First-line Treatment (CodeBreaK 201)
Clinical Trial IDs
- ORG STUDY ID:
20190288
- NCT ID:
NCT04933695
Conditions
- Non-small Cell Lung Cancer
Interventions
| Drug | Synonyms | Arms |
|---|
| Sotorasib | AMG 510 | Sotorasib: Dose A |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Sotorasib: Dose A | Experimental | Participants with metastatic non-small cell lung cancer (NSCLC) with 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 dose A. Participants will be stratified by known presence of STK11 mutation. | |
| Sotorasib: Dose B | Experimental | Participants with metastatic non-small cell lung cancer (NSCLC) with 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 dose B. Participants will be stratified by known presence of STK11 mutation. | |
Eligibility 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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Objective Response Rate (OR) |
| Time Frame: | Up to 6 years |
| Safety Issue: | |
| Description: | OR is defined as the total of Complete Response (CR) and Partial Response (PR). |
Secondary Outcome Measures
| Measure: | Disease Control Rate |
| Time Frame: | Up to 6 years |
| Safety Issue: | |
| Description: | |
| Measure: | Duration of Reponse (DOR) |
| Time Frame: | Up to 6 years |
| Safety Issue: | |
| Description: | |
| Measure: | Time to Response (TTR) |
| Time Frame: | Up to 6 years |
| Safety Issue: | |
| Description: | |
| Measure: | Progression-free Survival (PFS) |
| Time Frame: | Up to 6 years |
| Safety Issue: | |
| Description: | |
| Measure: | Overall Survival (OS) |
| Time Frame: | Up to 6 years |
| Safety Issue: | |
| Description: | |
| Measure: | Number of Participants with a Treatment-emergent Adverse Event (TEAE) |
| Time Frame: | Day 1 up to Month 13 |
| Safety Issue: | |
| Description: | |
| Measure: | Number of Participants with a Treatment-related Adverse Event |
| Time Frame: | Day 1 up to Month 13 |
| Safety Issue: | |
| Description: | |
| Measure: | Number of Participants with a Clinically Significant Change from Baseline in Vital Signs |
| Time Frame: | Baseline (Screening; up to 28 days pre-dose) up to Month 13 |
| Safety Issue: | |
| Description: | |
| Measure: | Number of Participants with a Clinically Significant Change from Baseline in Electrocardiograms (ECGs) |
| Time Frame: | Baseline (Screening; up to 28 days pre-dose) up to Month 13 |
| Safety Issue: | |
| Description: | |
| Measure: | Number of Participants with a Clinically Significant Change from Baseline in Clinical Laboratory Tests |
| Time Frame: | Baseline (Screening; up to 28 days pre-dose) up to Month 13 |
| Safety Issue: | |
| Description: | |
| Measure: | Maximum Plasma Concentration (Cmax) of Sotorasib |
| Time Frame: | Day 1 up to Month 3 |
| Safety Issue: | |
| Description: | |
| Measure: | Time to Reach Maximum Plasma Concentration (tmax) of Sotorasib |
| Time Frame: | Day 1 up to Month 3 |
| Safety Issue: | |
| Description: | |
| Measure: | Area Under the Plasma Concentration-time Curve (AUC) of Sotorasib |
| Time Frame: | Day 1 up to Month 3 |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Not yet recruiting |
| Lead Sponsor: | Amgen |
Trial Keywords
- Non-small cell lung cancer
- KRAS p.G12C
- Sotorasib
- AMG 510
Last Updated
June 22, 2021
