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An overview of the design and conduct of the BATTLE trials

Suyu Liu1, J Jack Lee2

  • 1Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.

Chinese Clinical Oncology
|September 27, 2015
PubMed

Insights

The Biomarker-integrated Approaches of Targeted Therapy for Lung Cancer Elimination (BATTLE) trials show that biomarker-based adaptive trials are feasible for developing personalized lung cancer therapies. These trials advance targeted treatment strategies for non-small cell lung cancer.

Area of Science:

  • Biomedicine
  • Genomics
  • Oncology

Background:

  • Advances in biomedicine and genomics are enabling personalized cancer medicine.
  • Lung cancer treatment has historically relied on broad approaches, necessitating more targeted strategies.

Purpose of the Study:

  • To describe the design and conduct of the BATTLE-1 and BATTLE-2 trials.
  • To summarize key findings and lessons learned from these biomarker-based adaptive trials.
  • To evaluate the feasibility and promise of novel clinical trial platforms for targeted cancer therapy.

Main Methods:

  • Prospective, biopsy-mandated, biomarker-based, adaptive randomized clinical trials.
  • Focus on patients with advanced non-small cell lung cancer (NSCLC).
  • Refinement of clinical trial design in the ongoing BATTLE-2 trial.

Main Results:

  • The BATTLE program demonstrated the feasibility of its adaptive trial design.
  • Biomarker-based approaches show promise for identifying effective targeted therapies.
  • The trials represent a step towards personalized medicine in lung cancer treatment.

Conclusions:

  • Biomarker-driven adaptive clinical trials are effective for advancing targeted lung cancer therapy.
  • The BATTLE program provides a successful model for personalized cancer medicine development.
  • Further refinement of trial design can enhance the discovery of novel targeted therapies.
Keywords:
Bayesian adaptive designspersonalized medicinepredictive biomarkerstargeted therapies

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