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 3

Completed

• Conditions: Lungcancer; non-small lung cancer; Non-squamous; 10027656; 10029107

• Registration Number: NL-OMON39879
• Lead Sponsor: Roche Nederland B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 25

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>2. OBJECTIVES<br /><br><br /><br>2.1 Primary Objective<br /><br>* To assess the efficacy of continuous bevacizumab treatment beyond PD1 as<br /><br>measured by OS.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>2.2 Secondary Objectives<br /><br>* To assess the efficacy as measured by rate of 6-, 12-, and 18-month OS as<br /><br>measured from randomization at PD1.<br /><br>* To assess the efficacy as measured by PFS and TTP from randomization at PD1<br /><br>to PD2 (PFS2, TTP2), and to PD3<br /><br>* To assess the efficacy as measured by RR, disease control rates, and duration<br /><br>of response at PD2 and PD3.<br /><br>* To assess the efficacy in the subgroup of adenocarcinoma patients.<br /><br>* To assess the safety of bevacizumab treatment across multiple lines of<br /><br>treatment.<br /><br><br /><br>2.3 Exploratory Objectives<br /><br>* To assess QoL through multiple lines of treatment.<br /><br>* To compare the efficacy between Asian and non-Asian patients.</p><br>