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Recruiting
Sponsor ID
20190341

A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non–Small Cell Lung Cancers (CodeBreaK 202)

Sponsor ID
20190341
Clinicaltrials.gov ID
NCT05920356
EUCTIS ID
2022-501863-41-00
EudraCT ID
N/A
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Study Details

The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.

Additional Study Details

Phase
Phase 3
Product
AMG 510
Type
Interventional
Masking
None (Open Label)
Enrollment
750
Additional Study Details

Protocol Summary

Primary Outcome Measures

Progression-free Survival (PFS)

Timeframe: Approximately 2.5 years

Overall Survival (OS)

Timeframe: Approximately 2.5 years

Secondary Outcome Measures

Objective Response Rate (ORR)

Timeframe: From Baseline up to end of study (EOS) (approximately 5.5 years)

Change in Quality-of-Life Questionnaire Core 30 (QLQ-C30) Dyspnea Domain Score

Timeframe: From Baseline to Week 12

Change in Quality-of-Life Questionnaire Lung Cancer 13 (QLQ-LC13) Symptoms of Dyspnea Subscale

Timeframe: From Baseline to Week 12

Change in QLQ-LC13 Symptoms of Cough Subscale

Timeframe: From Baseline to Week 12

Change in QLQ-LC13 Symptoms of Chest Pain Subscale

Timeframe: From Baseline to Week 12

Change in Physical Function as Measured by QLQ-C30

Timeframe: From Baseline to Week 12

Change in Global Health Status as Measured by QLQ-C30

Timeframe: From Baseline to Week 12

Progression-free Survival 2 (PFS2)

Timeframe: From Baseline up to EOS (approximately 5.5 years)

Change in QLQ-LC13 Subscale Scores

Timeframe: From Baseline up to EOS (approximately 5.5 years)

Change in QLQ-C30 Subscale Scores

Timeframe: From Baseline up to EOS (approximately 5.5 years)

Time to Deterioration in QLC-LC13 Subscale Scores

Timeframe: From Baseline to Week 12

Time to Deterioration in QLC-C30 Subscale Scores

Timeframe: From Baseline to Week 12

Change in Summary Scores and Visual Analogue Scale (VAS) Scores

Timeframe: From Baseline up to EOS (approximately 5.5 years)

Duration of Response

Timeframe: From Baseline up to EOS (approximately 5.5 years)

Time to Response

Timeframe: From Baseline up to EOS (approximately 5.5 years)

Disease Control

Timeframe: From Baseline up to EOS (approximately 5.5 years)

PFS

Timeframe: From Baseline up to EOS (approximately 5.5 years)

Objective Response

Timeframe: From Baseline up to EOS (approximately 5.5 years)

Number of Participants With Treatment-Emergent Adverse Events

Timeframe: From Baseline up to EOS (approximately 5.5 years)

Number of Participants With Clinically Significant Changes in Vital Signs

Timeframe: From Baseline up to EOS (approximately 5.5 years)

Number of Participants With Clinically Significant Changes in Clinical Laboratory Tests

Timeframe: From Baseline up to EOS (approximately 5.5 years)

Maximum Plasma Concentration (Cmax) of Sotorasib

Timeframe: Pre-dose Day 1 up to Day 64

Minimum Plasma Concentration (Cmin) of Sotorasib

Timeframe: Pre-dose Day 1 up to Day 64

Area Under The Curve (AUC) of Sotorasib

Timeframe: Pre-dose Day 1 up to Day 64

Locations

Location
Status
Contact Us
Location
Asan Medical Center
Seoul, Republic of Korea, 05505
Status
Recruiting
Location
Korea University Anam Hospital
Seoul, Republic of Korea, 02841
Status
Terminated
Location
The Alfred Hospital
Melbourne, VIC, Australia, 3004
Status
Completed
Location
GenesisCare -North Shore Oncology
St Leonards, NSW, Australia, 2065
Status
Completed
Location
Gachon University Gil Medical Center
Incheon, Republic of Korea, 21565
Status
Recruiting
Location
National Cancer Center
Goyang-si Gyeonggi-do, Republic of Korea, 10408
Status
Recruiting
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Study Info
Age
18 - 100 Years
Condition
  • Lung Cancer - Non-Small Cell
    • Sex
    All
    Trial Dates
    Nov 2023 - Jun 2027
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing • No history of systemic anticancer therapy in metastatic/non-curable settings • Eastern Cooperative Oncology Group (ECOG) ≤ 1
    Exclusion Criteria:
    • Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology • Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved as a front-line therapy • Symptomatic (treated or untreated) brain metastases • Gastrointestinal (GI) tract disease causing the inability to take oral medication • Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina • Prior therapy with a KRAS G12C inhibitor