An open-label, randomized, Phase IIIb trial evaluating the efficacy and safety of standard of care +/- continuous bevacizumab treatment beyond progression of disease (PD) in patients with advanced non-squamous non-small cell lung cancer (NSCLC) after first (1st)-line treatment with bevacizumab plus a platinum doublet-containing chemotherapy

Phase 1

• Conditions: ADVANCED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER (NSCLC); MedDRA version: 13.1Level: LLTClassification code 10066490Term: Progression of non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-17
• Study Completion: 2016-06-24
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 485

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 first-line 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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of continuous bevacizumab treatment beyond PD1 as measured by overall survival (OS).;Secondary Objective: • To assess the efficacy as measured by rate of 6-, 12-, and 18-month OS as measured from randomization at 1st progression of disease (PD1).<br>• To assess the efficacy as measured by progression free survival (PFS) and time to progression (TTP) from randomization at PD1, to second (2nd) PD (PD2) (PFS2, TTP2), and to third (3rd) PD (PD3)<br>• To assess the efficacy as measured by response rates (RRs), disease control rates, and duration of response at PD2 and PD3.<br>• To assess the efficacy in the subgroup of adenocarcinoma patients.<br>• To assess the safety of bevacizumab treatment across multiple lines of treatment.;Primary end point(s): Overall survival <br><br>