West Cancer Center

LUNG; Metastatic; NSCLC; Non-squamous; EGFR wt; 2nd Line; "MO22097"

_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_

Title

Hoffman-La Roche MO22097

Study Title

Site Link

NCT01351415

Malignancy

Lung Cancer, Lung Adenocarcinoma, Non-squamous

Stage

Stage 4

Disease Setting

Metastatic/palliative

Line Of Therapy

Investigational Agent

bevacizumab

Drug Class

angiogenesis inhibitor

Kurt Tauer, MD

Sponsor

Hoffman-La Roche

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

Key Eligibility Criteria Details

Non-squamous NSCLC___
PD following 1st line 4-6 cycles of platinum-doublet + bev, followed by at least 2 cycles of bev maintenance
No bev tx interruption more than 42 days
Randomization within 4 weeks of documented PD
ECOG PS 0-2
No mixed tumors (adenosquamous, NSCLC/SCLC)

Objective

__Primary- OS: Secondary: OS, PFS1, PFS2, TTP1, TTP2, ORR, DCR, DoR, safety, QOL, biomarker

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Once per 3 week cycle or less often

Path

Non squamous EGFR wild-type

Dosing Frequency

7.5 or 15 mg/kg q3 weeks

Control Agents

MD choice

Study Protocol

Randomized

Yes