BO44426
Research type
Research Study
Full title
A PHASE Ib/II, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE SAFETY, ACTIVITY, AND PHARMACOKINETICS OF GDC-6036 IN COMBINATION WITH OTHER ANTI-CANCER THERAPIES IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WITH A KRAS G12C MUTATION
IRAS ID
1007065
Contact name
Ramneet Jagdev
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2022-003048-28
Research summary
The purpose of this study is to evaluate the safety, pharmacokinetics, and activity of GDC-6036 combined with other anti-cancer therapies, such as pembrolizumab in patients with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC) which harbours a mutation called KRAS G12C.
GDC-6036 has been designed to block the KRAS G12C mutation which can promote the growth of cancer cells. Studies indicate that GDC-6036 is well-tolerated and may offer clinical benefit to patients with NSCLC. NSCLC remains an incurable disease with limited benefit from the available standard of care treatments, thus demonstrating an unmet medical need in this patient population.Pembrolizumab, alone or in combination with chemotherapy, is approved by the U.S. Food and Drug Administration and other health authorities worldwide as a treatment for several types of cancers including metastatic non-small cell lung cancer.
Approximately 60 people will take part in this study, and approximately 20 in the UK.
In this study participants will receive GDC-6036, given as a tablet once a day and pembrolizumab, given as an infusion every 3 weeks. If 200 mg dose of GDC-6036 in combination with pembrolizumab is determined to be safe and tolerable, newly enrolled participants may receive a higher dose of GDC-6036 in combination with pembrolizumab.
During this study, participants will have visits approximately every 3 weeks while they are receiving treatment and visits may last 2-6 hours. Participants will continue to take study treatment on a regular basis unless their lung cancer worsens. After the final dose, the study doctor will follow up each participant every 3 months. The total time in the study will depend on how each participants lung cancer responds to treatment. This could range from 1 day to more than 24 months.
The study is sponsored by F. Hoffman La Roche
Research Summary; Version Number 1.0 dated 12-Oct-2022
REC name
North East - York Research Ethics Committee
REC reference
23/NE/0026
Date of REC Opinion
14 Aug 2023
REC opinion
Further Information Favourable Opinion