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Clinical Trial Summary

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.


Clinical Trial Description

Dose selection The required dose amount for Alectinib is based on a fixed dose of 600 mg, and the dose for Bevacizumab when preparing the solution is based on the subject's weight in kilograms (kg). Dose Modification The administration of Alectinib/Bevacizumab will be stopped in case of Grade 4 hematological toxicities or Grade 3 non-hematological drug-related toxicities, including severe or life-threatening abnormalities. The test treatment should be discontinued if toxicity does not resolve to grade 0-1 within 12 weeks after the last application. With an adverse laboratory event still graded two, after 12 weeks, they can continue treatment at trial only if the reaction is asymptomatic and controlled. Subjects who experience a recurrence of the same severe or life-threatening event to the same or greater degree with a re-challenge of alectinib/bevacizumab should discontinue the trial treatment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03779191
Study type Interventional
Source Instituto Nacional de Cancerologia de Mexico
Contact
Status Completed
Phase Phase 2
Start date April 8, 2020
Completion date October 30, 2022

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