A phase IIIb trial for evaluating the efficacy and safety of standard treatment, with or without bevacizumab, in patients with advanced non-squamous non-small cell lung cancer (NSCLC) who progressed after first (1st)-line treatment with bevacizumab plus a platinum doublet-containing chemotherapy.

Phase 1

• Conditions: ocally recurrent or metastatic non-squamous NSCLC which has progressed beyond 1st-line treatment with bevacizumab plus a platinum doublet-containing chemotherapy regimen and bevacizumab (monotherapy) maintenance treatment.; MedDRA version: 14.1Level: LLTClassification code 10066490Term: Progression of non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-022645-14-IT
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-28
• Last Update Posted: 3 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

- Adult patients, age >/=18 years - Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC) - Documented progression of disease (locally recurrent or metastatic) per investigator assessment following firstline treatment 4-6 cycles of Avastin plus a platinum doublet-containing chemotherapy regimen and a minimum of 2 cycles of Avastin (monotherapy) maintenance treatment prior to first progression of disease - No treatment interruption of Avastin treatment greater than 2 consecutive cycles (42 days) between the start of first-line treatment to start of Cycle 1 of second line treatment - Randomization within 4 weeks of progression of disease - At least one unidimensionally measurable lesion meeting RECIST criteria - Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

Exclusion Criteria

- Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component - History of hemoptysis >/=grade 2 within 3 months of randomization - Major cardiac disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified