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Lung Master Protocol (Lung-MAP)-A Biomarker-Driven Protocol for Accelerating Development of Therapies for Squamous
Roy S Herbst1, David R Gandara2, Fred R Hirsch3
1Yale Cancer Center, Yale School of Medicine, New Haven, Connecticut. roy.herbst@yale.edu.
Abstract:
The Lung Master Protocol (Lung-MAP, S1400) is a groundbreaking clinical trial designed to advance the efficient development of targeted therapies for squamous cell carcinoma (SCC) of the lung. There are no approved targeted therapies specific to advanced lung SCC, although The Cancer Genome Atlas project and similar studies have detected a significant number of somatic gene mutations/amplifications in lung SCC, some of which are targetable by investigational agents. However, the frequency of these changes is low (5%-20%), making recruitment and study conduct challenging in the traditional clinical trial setting. Here, we describe our approach to development of a biomarker-driven phase II/II multisubstudy "Master Protocol," using a common platform (next-generation DNA sequencing) to identify actionable molecular abnormalities, followed by randomization to the relevant targeted therapy versus standard of care.
Insights
The Lung Master Protocol (Lung-MAP) trial advances targeted therapies for lung squamous cell carcinoma (SCC) by using next-generation sequencing to match patients with investigational treatments based on their specific genetic mutations.
Area of Science:
- Oncology
- Genetics
- Clinical Trials
Background:
- Lung squamous cell carcinoma (SCC) lacks approved targeted therapies.
- Genetic mutations in lung SCC are targetable but occur at low frequencies (5%-20%).
- Traditional clinical trials face recruitment challenges for rare molecular targets.
Purpose of the Study:
- To develop a biomarker-driven master protocol for efficient targeted therapy development in lung SCC.
- To utilize a common platform for identifying actionable molecular abnormalities.
- To randomize patients to targeted therapy versus standard of care based on genetic findings.
Main Methods:
- Implementation of the Lung Master Protocol (Lung-MAP, S1400).
- Utilizing next-generation DNA sequencing as a common platform.
- Biomarker-driven patient stratification and randomization.
Main Results:
- The master protocol facilitates the efficient development of targeted therapies.
- Next-generation sequencing identifies actionable molecular abnormalities in lung SCC.
- Randomization to targeted therapy versus standard of care is feasible.
Conclusions:
- The Lung-MAP master protocol provides an effective framework for advancing targeted therapies in lung SCC.
- This approach addresses the challenges of low-frequency targetable mutations.
- Biomarker-driven trials are crucial for personalized cancer treatment.
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