A study to assess the efficacy and safety of standard of care with / without continuous bevacizumab treatment beyond progression of disease in patients with advanced lung cancer.
- Conditions
- ADVANCED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER (NSCLC)MedDRA version: 20.0Level: LLTClassification code 10066490Term: Progression of non-small cell lung cancerSystem Organ Class: 100000015833Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-022645-14-DE
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
- 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 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150
- Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
- History of pulmonary hemorrhage/hemoptysis greater than or equal to 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 (OS)<br><br>;Timepoint(s) of evaluation of this end point: Measured from randomization to occurrence of event (death)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The rate of 6-, 12-, and 18-month OS as measured from randomization at progression PD1<br>PFS and TTP from randomization at progressive disease 1 (PD1), to PD2 (Progression Free Survival 2, Time to disease progression 2), and to PD3 Response rates, disease control rates, and duration of response at PD2 and PD3;Timepoint(s) of evaluation of this end point: Measured from randomization and time of progressive disease 2 (PD2) to occurrence of event