Clinical Study Data Request
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Proposal 1684

Title of the Proposed Research

Antiangiogenic agents in advanced non-small cell lung cancer patients who failed first-line chemotherapy: an individual patient data meta-analysis

Lead Researcher

Benjamin Besse


Gustave Roussy

Funding Source


Potential Conflicts of Interest


Data Sharing Agreement Date

13 April 2017

Lay Summary

Only 20% of patients with advanced non-small cell lung cancer (NSCLC) appear to benefit from the new immunotherapy treatment called immune checkpoint inhibitors after failure of the initial treatment as second-line treatment.

Creation of new vessels (or angiogenesis) by tumor is critical for tumor progression (i.e. growth). Antiangiogenic agents are used in combination with chemotherapy as a therapeutic strategy as first treatment in advanced NSCLC patients.

Several randomized studies have tested the efficacy of the combination of anti-angiogenic drugs plus chemotherapy or erlotinib with inconsistent benefit, limiting its acceptance in daily clinical practice.

A synthesis (or meta-analysis) of these studies using individual patient data (i.e. data of each patient included in these studies with preservation of their anonymity) instead of the summary data of each study will allow to study the variation of treatment effect and its toxicity according to patient factors such age or sex and biological factors such as Epidermal Growth factor mutation or the time from the start of the first treatment until progression. Results of this meta-analysis may allow us to identify patients that will benefit from anti-angiogenic treatment after failure of their first treatment and then have important implication for clinical practice.

Study Data Provided

ROCHE-OSI3364G: A Phase III, Multi-Center, Open Label, Randomized Clinical Trial to Evaluate The Efficacy of Avastin (BEVACIZUMAB) in Combination with Tarceva (Erlotinib Hydrochloride) Compared with Tarceva Alone for Treatment of Recurrent or Refractory Stage IIIB/IV Non Small Cell Lung Cancer
ROCHE-OSI2950G: A Phase II Randomized, Double-Blind, Multi-Center Study of Avastin Plus Docetaxel or Tarceva versus Docetaxel or Tarceva Alone in Patients with Recurrent or Refractory Non-Small Cell Lung Carcinoma

Statistical Analysis Plan

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.