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Alectinib in Combination With Bevacizumab in ALK Positive NSCLC

NCT03779191 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2023-07-06

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Instituto Nacional de Cancerologia de Mexico

    lead OTHER

Principal Investigators

  • Oscar G Arrieta Rodriguez, M.D., M.Sc. · Instituto Nacional de Cancerología de México

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-08
Primary Completion
2022-08-01
Completion
2022-10-30
FDA Drug
Yes

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03779191 on ClinicalTrials.gov