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Proposal 1847

Title of the Proposed Research

Antiangiogenic Second line Lung cancer Meta-Analysis (ANSELMA) - A meta-analysis on antiangiogenic agents in advanced non-small cell lung cancer patients who failed first-line chemotherapy.

Lead Researcher

Benjamin Besse

Affiliation

University Paris-Sud and Gustave Roussy, Department of Medicine
114 Rue Edouard Vaillant, 94805 Villejuif Cedex, France
Phone: +33 (0)1 42 11 43 22
Fax: +33 (0)1 42 11 52 19

Funding Source

This is an independent and academic meta-analysis and funding will be from the academic center. The meta-analysis platform is supported by the French League against Cancer, a charity. A grant from ARC, a charity, has been requested.

Potential Conflicts of Interest

Summary for all Researchers and Statistician No personal financial disclosures.
Institutional grants for clinical and translational research:
AstraZeneca, BMS, Boehringer-Ingelheim, Lilly, Pfizer, Roche-Genentech, Sanofi-Aventis, Clovis, GSK, Servier, EOS, Onxeo, OncoMed, Inivata, OSE Pharma.No personal financial disclosures.
Institutional grants for clinical and translational research:
unrestricted research grant in 2015 from Bayer for a meta-analysis of radionuclide in prostate cancer.

Data Sharing Agreement Date

21 August 2017

Lay Summary

After failure of the initial treatment, only 20% of patients with advanced non-small cell lung cancer (NSCLC) appear to benefit from immune checkpoint inhibitors as second treatment. Those inhibitors allow the immune system to be unleashed on cancer cells.

Creation of new blood vessels (process called angiogenesis) by the tumor is critical for tumor 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 antiangiogenic agents in combination with chemotherapy or erlotinib (another drug) with inconsistent benefit, limiting its acceptance in daily clinical practice. Then, this treatment may be proposed to the 80% of patients who do not benefit from immune checkpoint inhibitors. 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 information available in articles will allow to study the variation of treatment effects and toxicities according to patients’ factors such as age or sex, and biological factors such as mutation of the Epidermal Growth Factor (a protein known to be involved in many cancers) or the time from the start of the first treatment until tumor re-growth. Results of this meta-analysis may allow to identify patients who will benefit from antiangiogenic treatment after failure of their first treatment. Those results will have important implications for clinical practice. In order to have valid and reliable results, all randomized studies testing antiangiogenic agents will be included in the meta-analysis.

Study Data Provided

SANOFI-D4200C00036: A Phase III, Randomized, Double-blinded, Parallel Group, Multi-centre Study to Assess the Efficacy and Safety of ZD6474 (ZACTIMA™) in Combination With Pemetrexed (Alimta®) Versus Pemetrexed Alone in Patients With Locally-Advanced or Metastatic NSCLC
SANOFI-D4200C00006: A Randomized, Double-blind, Multicenter, Phase II Study to Assess the Safety, Tolerability, and Efficacy of ZD6474 in Combination With Docetaxel (TAXOTERE™) in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) After Failure of Prior Platinum-based Chemotherapy.
SANOFI-D4200C00032: A Phase III, Randomized, Double-Blinded, Multi-Center, Study to Assess the Efficacy of Docetaxel (TAXOTERE™) in Combination With ZD6474 (ZACTIMA™) Versus Docetaxel (TAXOTERE™) With Placebo in Subjects With Locally Advanced or Metastatic NSCLC

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.