A Phase 2, Multicenter, Open-label Study of Sotorasib (AMG 510) in Subjects with Stage IV NSCLC Whose Tumors Harbor a KRASG12C Mutation in Need of First-Line Treatment (CodeBreaK 201)

Phase 2

Withdrawn

• Conditions: Lung cancer; non small cell lung cancer; 10038666

• Registration Number: NL-OMON51994
• Lead Sponsor: Amgen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

• Untreated stage IV (per AJCC v8) NSCL
• Pathologically documented diagnosis of untreated metastatic stage IV NSCLC
with KRAS p.G12C mutation
• Aged over 18
• Life expectancy of at least 3 months
• A willingness to undertake the study procedures
• Subjects will undergo a pre-treatment tumor biopsy if medically feasible,
unless a sample is available within 3 months of enrollment. If a tumor biopsy
prior to treatment is not medically feasible and recent sample is not
available, subjects and investigators must be willing to provide archived tumor
tissue samples (formalin-fixed paraffin-embedded [FFPE]) sample collected
within 5 years.
• Measurable disease per investigator interpretation using RECIST 1.1
• Eastern Cooperative Oncology Group (ECOG) Performance Status of <= 1.

Refer to section 5.1 of the protocol.

Exclusion Criteria

• Must not have a history of mixed small cell and NSCLC
• Must not have a spinal cord compression or active brain metastases and/or
carcinomatous meningitis.
• Must not have HIV, hepatitis B and hepatitis C
• Myocardial infarction within 6 months of study day 1, symptomatic congestive
heart failure (New York Heart Association > Class II), unstable angina, or
cardiac arrythmia requiring medication.

Refer to section 5.2 of het protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Objective response (OR) (OR = complete response [CR] + partial response [PR]),<br /><br>measured by computed tomography (CT) or magnetic resonance imaging (MRI) and<br /><br>assessed per RECIST v1.1 per Blinded Independent Central Review (BICR)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Disease control (CR + PR + stable disease [SD])<br /><br>- Duration of response (DOR)<br /><br>- Time to response (TTR)<br /><br>- Progression-free survival (PFS)<br /><br>- Overall survival (OS)<br /><br><br /><br>- Treatment-emergent adverse events, treatment-related adverse events, and<br /><br>changes in vital signs, electrocardiogram [ECGs], and clinical laboratory<br /><br>tests.</p><br>