2024-02-13T00:00:00.000+11:00
Ongoing

CODEBREAK-202

CODEBREAK-202
Lung cancer

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 Patients with Stage IV and Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Positive for KRAS G12C

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 Patients with Stage IV and Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Positive for KRAS G12C

Trial overview

Topic

Lung cancer

Eligibility 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
Study details

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.

Further information

Please click here for more information

Location
Northshore :::

Thank you for submitting.

We will be in touch within 24 hours

An unexpected error has occurred.

You will need to complete the form again, sorry for the inconvenience.

How can we help?

If you have a medical emergency please call 000. If you have an urgent request and would like to speak to our staff, please contact one of our centres directly.

* Indicates a required field.