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Related Concept Videos

Clinical Trials01:16

Clinical Trials

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Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
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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.

Clinical Pharmacology and Therapeutics
|February 14, 2015
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Summary
This summary is machine-generated.

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.

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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.