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Hospital Clinico Universitario de Valencia | Nephrology Department

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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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Amgen

Status and phase

Enrolling
Phase 3

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Treatments

Drug: Sotorasib
Drug: Pembrolizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05920356
20190341
2022-501863-41 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

750 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

750 participants in 2 patient groups

Sotorasib combined with carboplatin and pemetrexed
Experimental group
Description:
Sotorasib administered in combination with carboplatin and pemetrexed.
Treatment:
Drug: Sotorasib
Pembrolizumab combined with carboplatin and pemetrexed
Active Comparator group
Description:
Pembrolizumab administered in combination with carboplatin and pemetrexed.
Treatment:
Drug: Pembrolizumab

Trial contacts and locations

250

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Central trial contact

Amgen Call Center

Data sourced from clinicaltrials.gov

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