Under construction – not a live service
Sign in
Taking people in BrazilPhase 3

Tests sotorasib with chemotherapy against pembrolizumab with chemotherapy in lung cancer

Tests sotorasib with chemotherapy in adults with advanced KRAS G12C lung cancer.

Plain-language title generated from the registry record
Registry title: 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)

Key facts

Where
Barretos, Belém, Belo Horizonte, Brasília, Cachoeiro de Itapemirim, Canoas, Itajaí, Natal, Porto Alegre, Recife, Rio de Janeiro, Salvador, Santa Cruz do Sul, Santos, São José do Rio Preto, and São Paulo, BrazilSee the 24 sites
Phase
Phase 3

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 100 years old?
  • Which best describes your lung cancer?
  • Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
  • What was the PD-L1 result of your tumour test?
  • Has your cancer spread to the brain?

Source: NCT05920356, who can take part

Where in Brazil

  • Fundacao pio xII BarretosBarretos, BrazilTaking people
  • Centro de Tratamento Oncologico - CtoBelém, BrazilNo longer taking part
  • Cenantron Centro Avançado de Tratamento Oncologico LtdaBelo Horizonte, BrazilTaking people
  • Nucleo de Ensino Pesquisa e Inovacao Mario PennaBelo Horizonte, BrazilNo longer taking part
  • Hospital Sirio Libanes BrasiliaBrasília, BrazilNo longer taking part
  • Oncoclinicas Onco Vida Distrito FederalBrasília, BrazilNo longer taking part
  • Hospital Evangelico de Cachoeiro de ItapemirimCachoeiro de Itapemirim, BrazilNo longer taking part
  • Associação Beneficente de CanoasCanoas, BrazilNo longer taking part
  • Clínica de Neoplasias LitoralItajaí, BrazilNo longer taking part
  • Liga Norte Riograndense Contra o CancerNatal, BrazilTaking people
  • Hospital Nossa Senhora da ConceiçãoPorto Alegre, BrazilTaking people
  • Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do SulPorto Alegre, BrazilTaking people
  • Irmandade Da Santa Casa de Misericordia de Porto AlegrePorto Alegre, BrazilTaking people
  • Instituto Medicina Integral ImipRecife, BrazilTaking people
  • Oncoclinicas Rio de Janeiro S ARio de Janeiro, BrazilTaking people
  • Nucleo de Oncologia da BahiaSalvador, BrazilNo longer taking part
  • Centro de pesquisa em oncologia Hospital Ana NerySanta Cruz do Sul, BrazilTaking people
  • Santa Casa de Misericordia de Santos - IscmsSantos, BrazilNo longer taking part
  • Hospital de Base de Sao Jose do Rio PretoSão José do Rio Preto, BrazilNo longer taking part
  • Fundacao Antonio PrudenteSão Paulo, BrazilTaking people
  • Instituto Cancer Sao Paulo IcespSão Paulo, BrazilTaking people
  • Sociedade Beneficente Israelita Brasileira Hospital Albert EinsteinSão Paulo, BrazilTaking people
  • Beneficencia Portuguesa de Sao Paulo - BpSão Paulo, BrazilNo longer taking part
  • Instituto de Ensino e Pesquisa Sao Lucas Iep Sao LucasSão Paulo, BrazilNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Amgen
Trial code
NCT05920356EU 2022-501863-41-00
Record updated
6 November 2026
Original description
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.Read full original descriptionShow less

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)

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.

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

ClinicalTrials.gov NCT05920356 · EU CTIS 2022-501863-41-00