NCT03779191

Alectinib in Combination With Bevacizumab in ALK Positive NSCLC

Phase II, Open Label, Single Arm Trial of Alectinib in Combination With Bevacizumab in Untreated and Previously Treated Patients With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) With Positive ALK Driver Mutation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Instituto Nacional de Cancerologia de Mexico · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• ALK Gene Rearrangement Positive
• Non-Squamous Non-Small Cell Neoplasm of Lung

Interventions

Type	Name	Description
DRUG	Alectinib	Alectinib dosed 600 mg twice a day (BID) with meals until disease progression, unacceptable toxicity, or other reasons specified in the protocol
DRUG	Bevacizumab	Bevacizumab 15 mg/kg intravenously every 3 weeks until disease progression, unacceptable toxicity, or other reasons specified in the protocol

Timeline

• Start date: 2020-04-08
• Primary completion: 2022-08-01
• Completion: 2022-10-30
• First posted: 2018-12-19
• Last updated: 2023-07-06

Locations

1 site across 1 country: Mexico

Regulatory

• FDA-regulated drug study