Study on Trametinib and Pembrolizumab for Treating Recurrent Non-small Cell Lung Cancer
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT03225664
This clinical trial is testing a combination of two drugs, trametinib and pembrolizumab, to see if they can effectively treat non-small cell lung cancer that has returned, spread, or cannot be removed by surgery. The study aims to find the best dose and evaluate the safety and effectiveness of this treatment.
Patient Parameters
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Program Overview
This study is exploring the use of two drugs, trametinib and pembrolizumab, to treat non-small cell lung cancer (NSCLC) that has come back, spread to other parts of the body, or cannot be surgically removed. Trametinib may help stop cancer cells from growing by blocking certain enzymes, while pembrolizumab is an immunotherapy that helps the immune system attack cancer cells. The study aims to determine the best dose of trametinib when used with pembrolizumab and to see how well this combination works in treating NSCLC.
Description
The study is divided into two parts: Phase Ib and Phase II. In Phase Ib, researchers will determine the safest dose of trametinib when combined with pembrolizumab. In Phase II, they will evaluate how well this combination works in treating patients with advanced non-small cell lung cancer (NSCLC) that has returned or spread after previous treatments.
Participants will take trametinib orally once a day for 14 days before starting the first cycle and then for 10 days in each cycle. Starting in the second cycle, they will also receive pembrolizumab through an IV infusion every three weeks. The treatment cycles will continue for up to two years unless the cancer progresses or side effects become unacceptable.
The study will monitor the overall response rate, safety, and tolerability of the treatment, as well as how long patients live without the cancer getting worse. Researchers will also study various biological markers to understand how the treatment affects the cancer and the immune system.
After completing the treatment, participants will have follow-up visits at 30 days and every three months for up to three years to monitor their health and any long-term effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of non-small cell lung cancer (NSCLC) that is metastatic, cannot be surgically removed, or has returned after treatment.
- Have a tumor that can be biopsied and agree to undergo a biopsy before starting the study treatment.
- Have been tested for specific genetic mutations (EGFR, ALK) and have received appropriate treatments if these mutations are present.
- Have measurable disease according to standard criteria.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have adequate blood cell counts and organ function as determined by specific blood tests.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 120 days after the last dose.
- Be able to swallow and retain oral medication.
- Have previously received certain cancer treatments, including MEK inhibitors and anti-PD-1 or anti-PD-L1 therapies, and meet specific criteria for resistance or progression on these treatments.
- Agree to provide written informed consent and comply with all study procedures.
Exclusion Criteria
- Have participated in another clinical trial or used an investigational device within four weeks of starting the study treatment.
- Have a diagnosis of immunodeficiency or are receiving systemic steroid therapy or other immunosuppressive treatments.
- Have had prior monoclonal antibody therapy within four weeks before starting the study.
- Have received previous immunomodulatory therapy and discontinued due to severe side effects.
- Have had recent chemotherapy, targeted therapy, or radiation therapy and have not recovered from side effects.
- Have another active cancer that requires treatment, except for certain non-threatening cancers.
- Have active brain metastases or cancer spread to the brain lining.
- Have active autoimmune disease requiring treatment in the past two years.
- Have lung disease or pneumonitis requiring systemic steroids.
- Have an active infection requiring treatment.
- Have symptomatic fluid buildup in the abdomen or around the lungs.
- Have a condition or treatment that might interfere with the study results or participation.
- Are pregnant or breastfeeding, or planning to become pregnant or father a child during the study.
- Have a history of HIV, active hepatitis B or C, or have received a live vaccine recently.
- Have a history of heart problems or are taking medications that affect heart rhythm.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Yale University | 06520 | New Haven | Connecticut |
| M D Anderson Cancer Center | 77030 | Houston | Texas |
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