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Master transcription regulators are regulatory proteins that are predominantly responsible for regulating the expression of multiple genes. Often these genes work in concert to drive a  complex process. Activation of a master transcription regulator can lead to a cascade of transcriptional activation necessary for that outcome. These regulators can directly bind to the regulatory sequences of the various genes involved, or they can indirectly regulate transcription by binding to regulatory...
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Master protocols in lung cancer: experience from Lung Master Protocol.

Vincent K Lam1, Vassiliki Papadimitrakopoulou

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|January 13, 2018
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Summary
This summary is machine-generated.

Master protocols like Lung-MAP accelerate biomarker-driven lung cancer therapies. While effective targeted treatments for lung squamous cell carcinoma (LUSC) remain challenging, these trials are crucial for advancing patient care.

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Area of Science:

  • Oncology
  • Clinical Trials
  • Biomarker Discovery

Background:

  • Metastatic lung cancer treatment is shifting towards personalized, biomarker-driven strategies.
  • Lung squamous cell carcinoma (LUSC) patients often lack effective targeted therapy options.
  • Master protocols offer innovative approaches to clinical trial design.

Purpose of the Study:

  • To review the role of master protocols, specifically the Lung-MAP trial, in advancing lung cancer treatment.
  • To assess the feasibility and adaptability of master protocols in evaluating novel biomarker-driven therapies for LUSC.
  • To highlight the challenges and successes in targeting LUSC with current therapeutic strategies.

Main Methods:

  • The Lung-MAP master protocol, an umbrella trial for advanced LUSC active since 2014.
  • Centralized, real-time biomarker screening.
  • Substudy modularity for protocol adaptability.

Main Results:

  • Centralized biomarker screening is feasible within a master protocol framework.
  • Substudy modularity is key for adapting trials to evolving treatment landscapes.
  • LUSC presents therapeutic challenges despite identified drivers, with limited success in targeted therapy.

Conclusions:

  • Master protocols are a feasible and efficient method for evaluating biomarker-driven lung cancer therapies.
  • Centrally coordinated trials like Lung-MAP are essential for delivering novel treatments rapidly.
  • These designs maximize research data quality while addressing less common genomic and immunotherapy subtypes.