Phase I/II Trial of Alectinib and Bevacizumab in Patients With Advanced, Anaplastic Lymphoma Kinase (ALK)-Positive, Non-Small Cell Lung Cancer

Conditions

This research study is evaluating two drugs, alectinib and bevacizumab, as possible treatments for Advanced Non-Small Cell Lung Cancer (NSCLC).

Experimental: Phase I Dose Level 1: Alectinib 600 mg + Bevacizumab 15 mg/kg
Participants were administered Alectinib 600 mg twice daily by mouth, and Bevacizumab 15 mg/kg intravenously once every 3 weeks. DLTs will be monitored and evaluated throughout the first cycle (21 days).
Experimental: Phase I Dose Level -1: Alectinib 600 mg + Bevacizumab 7.5 mg/kg
Participants were administered Alectinib 600 mg twice daily by mouth, and Bevacizumab 7.5 mg/kg intravenously once every 3 weeks. DLTs will be monitored and evaluated throughout the first cycle (21 days).
Experimental: Phase I Dose Level -2: Alectinib 450 mg + Bevacizumab 7.5 mg/kg
Participants were administered Alectinib 450 mg twice daily by mouth, and Bevacizumab 7.5 mg/kg intravenously once every 3 weeks. DLTs will be monitored and evaluated throughout the first cycle (21 days).
Experimental: Phase II: RP2D
In the phase II portion of the study, all patients received alectinib plus bevacizumab at the RP2D determined in the phase I portion.

(Phase 1) Recommended Phase II Dose of Alectinib [ Time Frame: first cycle of treatment (21 days) ]

Facility	City	State	ZIP	Site coordinators
Massachusetts General Hospital	Boston	Massachusetts	02115	-

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