Alectinib in Combination With Bevacizumab in ALK Positive NSCLC
- Sponsor
- Instituto Nacional de Cancerologia de Mexico
- Study ID
- NCT03779191
- Phase
- PHASE2
- Status
- Completed
Conditions
- ALK Gene Rearrangement Positive
- Non-Squamous Non-Small Cell Neoplasm of Lung
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Alectinib — DRUGAlectinib dosed 600 mg twice a day (BID) with meals until disease progression, unacceptable toxicity, or other reasons specified in the protocol
- Bevacizumab — DRUGBevacizumab 15 mg/kg intravenously every 3 weeks until disease progression, unacceptable toxicity, or other reasons specified in the protocol
Study Details
This single-arm, open-label, phase II clinical study aims to evaluate the progression-Free Survival (PFS) of the combination of Alectinib plus Bevacizumab in untreated and first and second-line chemotherapy failed subjects with stage IIIB/IV or recurrent disease after receiving radiation therapy or surgical resection. The main question to be answered is: Whether the combination of Alectinib plus Bevacizumab will improve PFS in untreated and previously treated subjects with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) and positive ALK translocation. Participants will be treated with Alectinib and Bevacizumab every three weeks until disease progression, unacceptable toxicity, or patient withdrawal of consent.
Key Dates
- First listed
- Dec 19, 2018
- Start date
- Apr 8, 2020
- Status verified
- Jul 2023
- Primary completion
- Aug 1, 2022
- Completion
- Oct 30, 2022
Study Design
- Enrollment
- 41 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: InterventionPatients in this intervention arm will receive the therapeutic combination of Alectinib dosed PO 600 mg bis in die (BID) with meals and Bevacizumab 15 mg/kg intravenously every 3 weeks until disease progression, unacceptable toxicity, or other reasons specified in the protocol
Primary Outcome Measure
Progression-free survival [ Time Frame: Through study completion, an average of 18 months ]