A Phase IB/II Study of Alectinib Combined With Cobimetinib in Advanced ALK-Rearranged (ALK+) NSCLC (NCT03202940) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Phase IB/II Study of Alectinib Combined With Cobimetinib in Advanced ALK-Rearranged (ALK+) NSCLC
United States16 participantsStarted 2017-09-14
Plain-language summary
This research study is studying a drug combination as a possible treatment for anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer.
The drugs involved in this study are:
* Alectinib
* Cobimetinib
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Ability to understand and the willingness to sign a written informed consent document.
* Age ≥ 18 years.
* Histologically or cytologically confirmed diagnosis of metastatic NSCLC (Stage IV, AJCC v7.0) that carries an ALK rearrangement, as determined by the Food and Drug Administration (FDA)-approved fluorescence in-situ hybridization (FISH) test, using Vysis® ALK Break apart FISH Probe, or the Ventana® immunohistochemistry (IHC) test. Diagnosis using next generation sequencing (NGS) via a local diagnostic test will be accepted for enrollment but will need to be confirmed with either FISH or IHC.
* For the expansion cohort: Patients must have had disease progression on alectinib (including patients who received alectinib as first-line treatment). Subsequent anti-neoplastic therapy (including other ALK inhibitors or chemotherapy) after progression on alectinib is not permitted. Note: patients in the dose-finding portion of the study may have received other anti-neoplastic therapy after progression on alectinib.
* At least one measurable lesion as defined by RECIST version 1.1. Previously irradiated lesions are not measurable unless the lesion has demonstrated clear progression after radiation.
* Eastern Cooperative Group (ECOG) performance status ≤ 2 for patients treated in the expansion phase. ECOG PS ≤ 1 is required for participants in the dose-finding portion of the study.
* Life expectancy of greater than 12 weeks
* Patient willingness and disease acc…