Phase 3 Study Sotorasib Vs Pembrolizumab in Nonsquamous Non–Small Cell Lung Cancers (CodeBreaK 202)

• Research type

  Research Study

• Full 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)

• IRAS ID

  1007818

• Contact name

  Matthew Rodaway

• Contact email

  UKRegClinical@amgen.com

• Sponsor organisation

  Amgen Inc.

• Eudract number

  2022-501863-41

• Clinicaltrials.gov Identifier

  NCT05920356

• Research summary

  This is a phase 3 study, the late stage of the development process of medicines for humans, where researchers want to learn about the effects of the anticancer drug sotorasib with platinum doublet chemotherapy, ie, carboplatin and pemetrexed (standard and widely used treatment) compared with pembrolizumab with platinum doublet chemotherapy in patients with Stage IV or advanced Stage IIIB/C nonsquamous programmed cell death ligand-1 (PD-L1) negative and KRAS p.G12C-mutation positive non-small cell lung cancer (NSCLC) and whether it causes any undesired effects. NSCLC is a disease in which increased growth of cancer cells form in the lung tissues, which can form tumours and spread (metastasize) to other body parts, becoming potentially deadly. KRAS mutations are common in many types of cancer. Knowing that the KRAS p.G12C mutation is present in your cancer allows the doctors to selectively target the mutation. The primary objective of the study is to compare progression-free survival (PFS) in subjects who receive sotorasib with platinum doublet chemotherapy versus subjects who receive pembrolizumab with platinum doublet chemotherapy. The study will be conducted at approx. 350 sites globally and will consist of a screening period, a treatment period, a safety follow up period and long term follow up period. Approximately 750 patients will be enrolled and randomised 1:1 to receive either sotorasib in combination with carboplatin and pemetrexed or pembrolizumab in combination with carboplatin and pemetrexed.
  Please see cover letter for remainder of response.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  23/LO/0883

• Date of REC Opinion

  16 Nov 2023

• REC opinion

  Further Information Favourable Opinion