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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)

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ClinicalTrials.gov Identifier: NCT05920356
Recruitment Status : Recruiting
First Posted : June 27, 2023
Last Update Posted : April 30, 2024
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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Brief Summary:
The primary objective of this study is to compare progression-free survival (PFS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer (NSCLC) Drug: Sotorasib Drug: Pembrolizumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : November 16, 2023
Estimated Primary Completion Date : February 28, 2026
Estimated Study Completion Date : March 1, 2031

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Sotorasib combined with carboplatin and pemetrexed
Sotorasib administered in combination with carboplatin and pemetrexed.
 Drug: Sotorasib
Oral administration
Other Names:
  • AMG 510
  • LUMYKRAS ®
  • LUMAKRAS ®
Active Comparator: Pembrolizumab combined with carboplatin and pemetrexed
Pembrolizumab administered in combination with carboplatin and pemetrexed.
 Drug: Pembrolizumab
Intravenous administration


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: From Baseline up to end of study (EOS) (approximately 5.5 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).


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: From Baseline up to 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. Overall Survival (OS) [ Time Frame: From Baseline up to EOS (approximately 5.5 years) ]
    OS is defined as the time from randomization until death due to any cause.

  3. Change in Quality-of-Life Questionnaire Core 30 (QLQ-C30) Dyspnea Domain Score [ Time Frame: From Baseline to Week 12 ]
  4. Change in Quality-of-Life Questionnaire Lung Cancer 13 (QLQ-LC13) Symptoms of Dyspnea Subscale [ Time Frame: From Baseline to Week 12 ]
  5. Change in QLQ-LC13 Symptoms of Cough Subscale [ Time Frame: From Baseline to Week 12 ]
  6. Change in QLQ-LC13 Symptoms of Chest Pain Subscale [ Time Frame: From Baseline to Week 12 ]
  7. Change in Physical Function as Measured by QLQ-C30 [ Time Frame: From Baseline to Week 12 ]
  8. Change in Global Health Status as Measured by QLQ-C30 [ Time Frame: From Baseline to Week 12 ]
  9. 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 treatment beyond progression (ie, second progression) or death from any cause, whichever occurs first.

  10. Change in QLQ-LC13 Subscale Scores [ Time Frame: From Baseline up to EOS (approximately 5.5 years) ]
  11. Change in QLQ-C30 Subscale Scores [ Time Frame: From Baseline up to EOS (approximately 5.5 years) ]
  12. Time to Deterioration in QLC-LC13 Subscale Scores [ Time Frame: From Baseline to Week 12 ]
  13. Time to Deterioration in QLC-C30 Subscale Scores [ Time Frame: From Baseline to Week 12 ]
  14. 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).

  15. 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.

  16. 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.

  17. 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.

  18. PFS [ Time Frame: From Baseline up to EOS (approximately 5.5 years) ]
    Based on investigator tumor assessments per RECIST v1.1.

  19. Objective Response [ Time Frame: From Baseline up to EOS (approximately 5.5 years) ]
    Based on investigator tumor assessments per RECIST v1.1.

  20. Number of Participants With Treatment-Emergent Adverse Events [ Time Frame: From Baseline up to EOS (approximately 5.5 years) ]
  21. Number of Participants With Clinically Significant Changes in Vital Signs [ Time Frame: From Baseline up to EOS (approximately 5.5 years) ]
  22. Number of Participants With Clinically Significant Changes in Clinical Laboratory Tests [ Time Frame: From Baseline up to EOS (approximately 5.5 years) ]
  23. Maximum Plasma Concentration (Cmax) of Sotorasib [ Time Frame: Pre-dose Day 1 up to Day 64 ]
  24. Minimum Plasma Concentration (Cmin) of Sotorasib [ Time Frame: Pre-dose Day 1 up to Day 64 ]
  25. Area Under The Curve (AUC) of Sotorasib [ Time Frame: Pre-dose Day 1 up to Day 64 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05920356


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
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Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT05920356    
Other Study ID Numbers: 20190341
2022-501863-41 ( EudraCT Number )
First Posted: June 27, 2023    Key Record Dates
Last Update Posted: April 30, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
URL: http://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
Oncology
Lung Cancer
PD-L1
KRAS p.G12C
Sotorasib
Pembrolizumab
Carboplatin
 Pemetrexed
CodeBreaK 202
NSCLC
PD-L1 Negative
AMG 510
LUMAKRAS ®
LUMYKRAS ®
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Pembrolizumab
Sotorasib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action