Study on Trametinib and Docetaxel for Treating Advanced KRAS Mutation Positive Non-small Cell Lung Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02642042
This clinical trial is testing a combination of two drugs, trametinib and docetaxel, to see if they can effectively treat patients with advanced non-small cell lung cancer that has a specific KRAS mutation and has either returned or not responded to previous treatments.
Patient Parameters
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Program Overview
This study is exploring how well the drugs trametinib and docetaxel work together to treat patients with advanced non-small cell lung cancer (NSCLC) that has a KRAS mutation. Trametinib may help stop cancer cells from growing by blocking certain enzymes, while docetaxel is a chemotherapy drug that can kill cancer cells or stop them from spreading. The goal is to see if using these drugs together is more effective than using them separately.
Description
The main goal of this study is to see how well the combination of trametinib and docetaxel works in patients with advanced non-small cell lung cancer (NSCLC) that has a KRAS mutation. Researchers want to know if this combination can shrink tumors in patients who have already tried one or two other treatments.
Secondary goals include:
- Checking if the combination works well in patients with a specific type of KRAS mutation called G12C.
- Seeing how long patients live without the cancer getting worse.
- Evaluating the safety and side effects of the treatment.
- Understanding how long patients live overall after receiving the treatment.
The study also aims to collect samples for future research and to see how other genetic changes in the cancer might affect treatment outcomes.
Participants will take trametinib by mouth for 21 days and receive docetaxel through an IV on the first day of each 21-day cycle. This will continue as long as the cancer does not progress and side effects are manageable. After finishing the treatment, patients will have follow-up visits every six months for three years.
Eligibility Criteria
Inclusion Criteria
- Have advanced non-small cell lung cancer (NSCLC) with a confirmed KRAS mutation.
- Cancer must be measurable by scans and not have spread to the brain or spinal cord unless treated and stable.
- Have tried one or two previous treatments for lung cancer, including a platinum-based chemotherapy.
- Be in good overall health with a performance status score of 0 to 2.
- Have adequate blood counts and organ function based on specific lab tests.
- Be able to swallow pills and not have digestive issues that affect absorption.
- Not have significant heart or lung diseases or other serious health conditions.
- Not be pregnant or breastfeeding and agree to use effective birth control during the study and for four months after.
- Agree to provide informed consent and participate in optional specimen banking for future research.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| CHI Saint Vincent Cancer Center Hot Springs | 71913 | Hot Springs | Arkansas |
| NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro | 72401 | Jonesboro | Arkansas |
| PCR Oncology | 93420 | Arroyo Grande | California |
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