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NCT Number: NCT05920356

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)

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.

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Key information

Conditions

Non-small Cell Lung Cancer (NSCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Britanico de Buenos Aires, CABA, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sotorasib

Drug

Oral administration

Other names: AMG 510, LUMYKRAS ®, LUMAKRAS ®

Pembrolizumab

Drug

Intravenous administration

Primary outcomes

  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.

Secondary outcomes

  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 on RECIST 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, whichever occurs first.

  15. Time to Response

    Time frame: From Baseline up to EOS (approximately 5.5 years)

    Defined as the time from randomization to first evidence of PR or CR per BICR.

  16. Disease Control

    Time frame: From Baseline up to EOS (approximately 5.5 years)

    Defined as CR plus PR plus stable disease based on RECIST v1.1 per BICR.

  17. PFS

    Time frame: From Baseline up to EOS (approximately 5.5 years)

    Based on investigator tumor assessments per RECIST v1.1.

  18. Objective Response

    Time frame: From Baseline up to EOS (approximately 5.5 years)

    Based on investigator tumor assessments per RECIST v1.1.

  19. Number of Participants With Treatment-Emergent Adverse Events

    Time frame: From Baseline up to EOS (approximately 5.5 years)

  20. Number of Participants With Clinically Significant Changes in Vital Signs

    Time frame: From Baseline up to EOS (approximately 5.5 years)

  21. Number of Participants With Clinically Significant Changes in Clinical Laboratory Tests

    Time frame: From Baseline up to EOS (approximately 5.5 years)

  22. Maximum Plasma Concentration (Cmax) of Sotorasib

    Time frame: Pre-dose Day 1 up to Day 64

  23. Minimum Plasma Concentration (Cmin) of Sotorasib

    Time frame: Pre-dose Day 1 up to Day 64

  24. Area Under The Curve (AUC) of Sotorasib

    Time frame: Pre-dose Day 1 up to Day 64

Study contacts

Contact information is provided by the study sponsor or research team.

Amgen Call Center

CONTACT

[email protected]

866-572-6436

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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)

Important dates

Study start
2023
Primary completion
2027
Study completion
2032
First posted
Jun 27, 2023
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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