A Phase 2 Study of MRTX849 and Pembrolizumab in Advanced NSCLC
Research type
Research Study
Full title
A Phase 2 Trial of Adagrasib Monotherapy and in Combination with Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination with Pembrolizumab versus Pembrolizumab in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation
IRAS ID
1004279
Contact name
Vicky Kang
Contact email
Sponsor organisation
Mirati Therapeutics, Inc.
Eudract number
2020-003101-58
ISRCTN Number
ISRCTN13464104
Clinicaltrials.gov Identifier
Research summary
Study 849-007 is an open label, randomised or partly randomised depending on the cohort assigned, Phase 2 clinical trial evaluating the effectiveness of the investigational medication MRTX849, administered alone or in combination with the cancer therapy called pembrolizumab in patients with non-small cell lung cancer who have a specific change in a tumour gene (KRAS G12C mutation). Other objectives of the study include assessing side effects and how often they occur, how quickly MRTX849 is absorbed into the blood stream, and how fast it is removed by the body.
During the screening period of the study, results of previous genetic testing are required to determine if the participant has the KRAS G12C Mutation. If previous results are not available, tumour tissue samples or blood may need to be collected from participants to complete this testing prior to enrolment. Participants who pass the screening period, will also be required to submit tumour tissue to complete further genetic tests. If tumour tissue is not already available from a previous surgery or biopsy tissue may need to be collected from participants at the time of enrolment.
Eligible participants will be assigned to one of three treatment groups that will receive either MRTX849 and pembrolizumab or MRTX849 alone, based on their Tumour Proportion score (TPS). Participants with a TPS value of less than 1 will be randomised to receive either MRTX849 and pembrolizumab or MRTX849 alone, whereas participants with a TPS of more than or equal to 1 will receive treatment with both MRTX849 and pembrolizumab. Several laboratory tests will be performed using samples of tumour tissue or blood. Study treatment will be administered in 21-day cycles until disease progression, unacceptable adverse reaction(s) or receipt of the maximal number of cycles per local standard-of-care.
This study is expected to be conducted at approximately 204 study sites globally and approximately 250 patients.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
22/EE/0062
Date of REC Opinion
13 Apr 2022
REC opinion
Further Information Favourable Opinion