Combination Study of RMC-4630 and Sotorasib for NSCLC Subjects

• Research type

  Research Study

• Full title

  A Phase 2, Open-Label, Multicenter Study of the Combination of RMC-4630 and Sotorasib for Non-Small Cell Lung Cancer Subjects with KRASG12C Mutation After Failure of Prior Standard Therapies

• IRAS ID

  1005206

• Contact name

  Chau Truong

• Contact email

  ctruong@RevMed.com

• Sponsor organisation

  Revolution Medicines, Inc.

• Eudract number

  2021-003254-23

• Clinicaltrials.gov Identifier

  NCT05054725

• Research summary

  Thе study is designed for patients with Non-Small Cell Lung Cancer Subjects with KRASG12C Mutation After Failure of Prior Standard Therapies. This study will test the safety and anti-tumour effects of тхе new drug called RMC 4630 and sotorasib when given together in patients with KRAS G12C-mutated locally advanced or metastatic NSCLC. Both RMC 4630 and sotorasib will be administered orally.
  The study will be conducted at approximately 40 clinical sites globally and is expected to enroll up to approximately 46 patients, with 40 efficacy-evaluable patients s at the final dose in the expansion period. In UK it is anticipated 3 patients to be enrolled in 2 sites.
  The subject will take RMC 4630 with sotorasib as long as they can tolerate the combination of the study drugs or until thei cancer worsens. Within 30 days after your last dose of study treatment, subjects will have a follow-up visit. After that they will be contacted every 3 months until the end of the study. The subject total participation in the study will depend on how well theytolerate the study treatment and how their cancer responds to study treatment. The total duration of the study is approximately 2 years. Subjects participation could range from 1 day to 2 years.
  This study has 3 periods:
  1. Screening period
  2. Study Treatment period
  3. Follow up period
  In addition, this study is divided into two parts:
  - Part A (safety run-in): up to 6 subjects will be enrolled during the safety run-in portion of the study, in which RMC-4630 will be administered at the starting dose of 140 mg on Day 1 and Day 2 of each week along with 960 mg of sotorasib daily. The decision to increase the RMC-4630 dose to 200 mg on Day1/DayD2 will be guided by an mTPI-2 algorithm and made by the Dose Committee.
  - Part B (dose expansion): A larger number of participants will be enrolled, and will receive the expansion dose of RMC-4630 and sotorasib. Once Part B has been initiated, all subjects will enroll into PartB

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  22/NW/0163

• Date of REC Opinion

  28 Jul 2022

• REC opinion

  Further Information Favourable Opinion