Trametinib and Pembrolizumab in Treating Patients With Recurrent Non-small Cell Lung Cancer That … (NCT03225664) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Trametinib and Pembrolizumab in Treating Patients With Recurrent Non-small Cell Lung Cancer That Is Metastatic, Unresectable, or Locally Advanced
United States37 participantsStarted 2018-02-03
Plain-language summary
This phase Ib/II trial studies the side effects and best dose of trametinib when given together with pembrolizumab and to see how well they work in treating patients with non-small cell lung cancer that has come back and spread to other places in the body, cannot be removed by surgery, or spread to nearby tissues or lymph nodes. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving trametinib and pembrolizumab may work better in treating patients with non-small cell lung cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of metastatic or unresectable, locally advanced, recurrent NSCLC that has been previously treated (subjects who have failed adjuvant or locally advanced therapy within 6 months are also eligible to participate in the study)
* The subject has biopsy accessible tumor and is willing to undergo biopsy prior to planned protocol treatment
* Confirmation of the presence or absence of EGFR mutations and ALK gene fusions prior to study enrollment in all subjects except for patients with histologies other than adenocarcinoma and NSCLC, not otherwise specified (NOS), as the frequency of these alterations is exceedingly rare in this histology. Subjects with known EGFR sensitizing mutational status or ALK fusion must have been treated and progressed on EGFR TKIs or ALK-directed therapy, or with tumors harboring EGFR T790M mutation to have received and progressed on therapy directed at the T790M mutation (e.g. osimertinib). Subjects with known ROS1 translocation must have been treated and progressed on ROS1-directed therapy
* Measurable disease according to RECIST 1.1 and irRECIST. At least one lesion of at least 1.0 cm in the long-axis diameter for a non-lymph node or at least 1.5 cm in the short-axis diameter for a lymph node which is serially measurable according to RECIST 1.1 and irRECIST using either computed tomography (CT) or magnetic resonance imaging (MRI). If there is only one target lesion and it is a non…
What they're measuring
1
Overall objective response rate evaluated according to modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1 and immune related [ir]RECIST)