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)

A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2061230078

Enrollment

750

Registered

2023-12-06

Start date

2023-11-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Interventions

- Experimental: Sotorasib combined with carboplatin and pemetrexed Sotorasib administered in combination with carboplatin and pemetrexed. Intervention: Drug: Sotorasib - Active Comparator: Pembro

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 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 2. No history of systemic anticancer therapy in metastatic/non-curable settings 3. Eastern Cooperative Oncology Group (ECOG) <= 1

Exclusion criteria

Exclusion criteria: 1. Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology 2. Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved as a front-line therapy 3. Symptomatic (treated or untreated) brain metastases 4. Gastrointestinal (GI) tract disease causing the inability to take oral medication 5. Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina 6. Prior therapy with a KRAS G12C inhibitor

Design outcomes

Primary

Measure	Time frame
1. Progression-free Survival (PFS) [Time Frame: Approximately 2.5 years] PFS is defined as the time from randomization until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first. Progression will be based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, per Blinded Independent Central Review (BICR). 2. Overall Survival (OS) [Time Frame: Approximately 2.5 years] OS is defined as the time from randomization until death due to any cause.	—

Measure

Time frame

1. Progression-free Survival (PFS) [Time Frame: Approximately 2.5 years] PFS is defined as the time from randomization until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first. Progression will be based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, per Blinded Independent Central Review (BICR). 2. Overall Survival (OS) [Time Frame: Approximately 2.5 years] OS is defined as the time from randomization until death due to any cause.

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Secondary

Measure	Time frame
1. Objective Response Rate (ORR) [Time Frame: From Baseline up to end of study (EOS) (approximately 5.5 years)] Objective response is defined as the best overall response of complete response (CR) or partial response (PR), based onRECIST v1.1, per BICR. 2. Change in Quality-of-Life Questionnaire Core 30 (QLQ-C30) Dyspnea Domain Score [Time Frame: From Baseline to Week 12] 3. Change in Quality-of-Life Questionnaire Lung Cancer 13 (QLQ-LC13) Symptoms of Dyspnea Subscale [Time Frame: From Baseline to Week 12] 4. Change in QLQ-LC13 Symptoms of Cough Subscale [Time Frame: From Baseline to Week 12] 5. Change in QLQ-LC13 Symptoms of Chest Pain Subscale [Time Frame: From Baseline to Week 12] 6. Change in Physical Function as Measured by QLQ-C30 [Time Frame: From Baseline to Week 12] 7. Change in Global Health Status as Measured by QLQ-C30 [Time Frame: From Baseline to Week 12] 8. Progression-free Survival 2 (PFS2) [Time Frame: From Baseline up to EOS (approximately 5.5 years)] PFS2 is defined as the time from randomization to progression per investigator after initiation of new anticancer therapy or death from any cause, whichever occurs first. 9. Change in QLQ-LC13 Subscale Scores [Time Frame: From Baseline up to EOS (approximately 5.5 years)] 10. Change in QLQ-C30 Subscale Scores [Time Frame: From Baseline up to EOS (approximately 5.5 years)] 11. Time to Deterioration in QLC-LC13 Subscale Scores [Time Frame: From Baseline to Week 12] 12. Time to Deterioration in QLC-C30 Subscale Scores [Time Frame: From Baseline to Week 12] 13. Change in Summary Scores and Visual Analogue Scale (VAS) Scores [Time Frame: From Baseline up to EOS (approximately 5.5 years)] Measured by EuroQol-5 Dimension (EQ-5D-5L). 14. Duration of Response [Time Frame: From Baseline up to EOS (approximately 5.5 years)] Duration of response is defined as the time from the first documentation of objective response until the first documentation of disease progression per BICR or death due to any cause,	—

Measure

Time frame

1. Objective Response Rate (ORR) [Time Frame: From Baseline up to end of study (EOS) (approximately 5.5 years)] Objective response is defined as the best overall response of complete response (CR) or partial response (PR), based onRECIST v1.1, per BICR. 2. Change in Quality-of-Life Questionnaire Core 30 (QLQ-C30) Dyspnea Domain Score [Time Frame: From Baseline to Week 12] 3. Change in Quality-of-Life Questionnaire Lung Cancer 13 (QLQ-LC13) Symptoms of Dyspnea Subscale [Time Frame: From Baseline to Week 12] 4. Change in QLQ-LC13 Symptoms of Cough Subscale [Time Frame: From Baseline to Week 12] 5. Change in QLQ-LC13 Symptoms of Chest Pain Subscale [Time Frame: From Baseline to Week 12] 6. Change in Physical Function as Measured by QLQ-C30 [Time Frame: From Baseline to Week 12] 7. Change in Global Health Status as Measured by QLQ-C30 [Time Frame: From Baseline to Week 12] 8. Progression-free Survival 2 (PFS2) [Time Frame: From Baseline up to EOS (approximately 5.5 years)] PFS2 is defined as the time from randomization to progression per investigator after initiation of new anticancer therapy or death from any cause, whichever occurs first. 9. Change in QLQ-LC13 Subscale Scores [Time Frame: From Baseline up to EOS (approximately 5.5 years)] 10. Change in QLQ-C30 Subscale Scores [Time Frame: From Baseline up to EOS (approximately 5.5 years)] 11. Time to Deterioration in QLC-LC13 Subscale Scores [Time Frame: From Baseline to Week 12] 12. Time to Deterioration in QLC-C30 Subscale Scores [Time Frame: From Baseline to Week 12] 13. Change in Summary Scores and Visual Analogue Scale (VAS) Scores [Time Frame: From Baseline up to EOS (approximately 5.5 years)] Measured by EuroQol-5 Dimension (EQ-5D-5L). 14. Duration of Response [Time Frame: From Baseline up to EOS (approximately 5.5 years)] Duration of response is defined as the time from the first documentation of objective response until the first documentation of disease progression per BICR or death due to any cause,

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Countries

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Denmark, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Peru, Poland, Portugal, Puerto Rico, Romania, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States

Contacts

Public ContactContact Local

Amgen K.K.

clinicaltrials_japan@amgen.com+81-80-7217-8592

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026