Lung-MAP--framework, overview, and design principles

Area of Science:

• Oncology
• Clinical Trials
• Genomics

Background:

• Metastatic lung squamous cell carcinoma (SCC) presents limited treatment options and poor prognoses.
• Traditional clinical trials often fail to benefit most patients due to heterogeneity.
• Biomarker-matched targeted therapies offer potential but face challenges with low-frequency alterations and high screen-failure rates.

Purpose of the Study:

• To introduce the Lung-MAP (Lung Cancer Master Protocol) umbrella protocol for recurrent or metastatic lung SCC.
• To describe Lung-MAP's innovative structure for efficient patient allocation to biomarker-matched trials.
• To highlight the protocol's goal of improving treatment efficacy and patient outcomes.

Main Methods:

• Lung-MAP utilizes a central genomic profiling platform for patient screening.
• Patients are assigned to biomarker-matched phase II/III targeted therapy trials or a non-matched arm.
• An adaptive design allows sub-studies to progress from phase II to phase III based on efficacy, incorporating prior patients.

Main Results:

• The protocol ensures all screened eligible patients receive treatment under the protocol.
• The adaptive structure facilitates efficient progression of promising treatments.
• The design aims to expedite FDA approval for novel lung SCC therapies.

Conclusions:

• Lung-MAP provides an efficient and adaptable framework for lung SCC research.
• The protocol optimizes patient enrollment and treatment matching.
• The ultimate goal is to significantly improve the quality and length of life for lung SCC patients.