Study on Adagrasib, Pembrolizumab, and Chemotherapy vs. Placebo, Pembrolizumab, and Chemotherapy for Untreated Non-Squamous Non-Small Cell Lung Cancer with KRAS G12C Mutation
Sponsor: Mirati Therapeutics Inc.
ClinicalTrials ID:NCT06875310
This clinical trial is testing a new combination of drugs, including Adagrasib and Pembrolizumab, with chemotherapy to see if it is more effective than a placebo with Pembrolizumab and chemotherapy in treating patients with advanced non-squamous non-small cell lung cancer (NSCLC) that has a specific KRAS G12C mutation.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to evaluate how well a new treatment combination works and how safe it is for patients with advanced non-squamous non-small cell lung cancer (NSCLC) that has not been treated before and has a specific genetic mutation called KRAS G12C. The study compares the effects of adding Adagrasib to Pembrolizumab and chemotherapy against using a placebo with Pembrolizumab and chemotherapy.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with non-squamous non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation, confirmed by lab tests.
- Cancer must be advanced or has spread to other parts of the body.
- Must have at least one tumor that can be measured by a CT or MRI scan.
- Have not received any previous treatment for advanced or metastatic cancer.
- Not suitable for treatments like chemoradiation or complete surgical removal of the cancer.
- Can have brain metastases if they are not causing symptoms and do not need immediate treatment. Any untreated brain metastases must be 20 mm or smaller.
- Any level of PD-L1 expression is acceptable, as determined by specific lab tests.
Exclusion Criteria
- Have an active or known autoimmune or inflammatory disease.
- Have serious heart conditions that are not controlled, occurring within the last 6 months.
- Have poor bone marrow or liver function or abnormal heart rhythms.
- Taking medications that affect heart rhythm and cannot be changed before starting the study.
- Have received treatments targeting the KRAS G12C mutation before.
- Have other serious medical or mental health conditions that could increase risks during the study.
- Other specific criteria may apply as defined by the study protocol.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Local Institution - 0347 | 35294-3300 | Birmingham | Alabama |
| Local Institution - 0581 | 92835 | Fullerton | California |
| Local Institution - 0202 | 90805 | Long Beach | California |
| Local Institution - 0643 | 92663 | Newport Beach | California |
| Local Institution - 0666 | 92868 | Orange | California |
| Local Institution - 0623 | 93105 | Santa Barbara | California |
| Local Institution - 0442 | 80206 | Denver | Colorado |
| Local Institution - 0651 | 32610 | Gainesville | Florida |
| Local Institution - 0621 | 32901 | Palm Bay | Florida |
| Local Institution - 0377 | 33321 | Tamarac | Florida |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.
