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Innovative Clinical Trials: The LUNG-MAP Study
C E Steuer1, V Papadimitrakopoulou, R S Herbst
1Winship Cancer Institute, Emory University, Atlanta, Georgia, USA.
Abstract:
Although the proportion of patients with squamous cell carcinoma of the lung has declined over the last two decades, the disease is still fatal for tens of thousands of patients each year. The treatment of non-small cell lung cancer has advanced rapidly over the past decade, providing novel, targeted therapeutic options to patients, but has mostly been limited to the adenocarcinoma histology. Efforts are currently underway to bring squamous cell carcinoma of the lung into this new era of targeted therapy. This article reviews the rationale and trial design for the "LUNG-MAP: S1400 Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy of Squamous Cell Lung Cancer" study. This multi-institutional, multi-cooperative group trial aims to individualize treatment for patients with metastatic squamous cell carcinoma to one of five arms based on the genomic profile of the tumor. The goal of this clinical trial is to rapidly identify new active drugs and bring them as soon as possible through a registration process for patients with squamous cell lung cancer by utilizing a novel trial design and involving all key stakeholders in drug development in a national effort. This could serve as a paradigm for drug development for malignancies with wide molecular heterogeneity.
Insights
The LUNG-MAP study individualizes treatment for squamous cell lung cancer using genomic profiling. This biomarker-driven approach aims to accelerate the development of targeted therapies for patients with this fatal disease.
Area of Science:
- Oncology
- Clinical Trials
- Genomics
Background:
- Squamous cell carcinoma of the lung remains a fatal disease, with limited targeted therapy options compared to adenocarcinoma.
- Recent advancements in non-small cell lung cancer treatment have primarily benefited adenocarcinoma histology.
- There is a critical need to develop targeted therapies for squamous cell lung cancer.
Purpose of the Study:
- To review the rationale and design of the LUNG-MAP (S1400) study.
- To individualize treatment for metastatic squamous cell lung cancer based on tumor genomic profiles.
- To accelerate the identification and registration of new drugs for squamous cell lung cancer.
Main Methods:
- The LUNG-MAP study employs a biomarker-driven master protocol for second-line therapy.
- It is a multi-institutional, multi-cooperative group Phase II/III clinical trial.
- Treatment is assigned to one of five arms based on the patient's tumor genomic profile.
Main Results:
- The study is designed to rapidly identify new active drugs for squamous cell lung cancer.
- It utilizes a novel trial design involving key stakeholders in drug development.
- The trial aims to establish a paradigm for developing therapies in molecularly heterogeneous malignancies.
Conclusions:
- The LUNG-MAP study represents a novel approach to targeted therapy development for squamous cell lung cancer.
- This biomarker-driven master protocol has the potential to expedite drug registration.
- The trial design could serve as a model for future drug development in similar cancers.
