Last updated on August 2019

Lung-MAP: A Master Screening Protocol for Previously-Treated Non-Small Cell Lung Cancer


Brief description of study

This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid Master Protocol (Lung-MAP). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes non-match sub-studies which will include all screened patients not eligible for any of the biomarker-driven sub-studies.

Detailed Study Description

Primary Objective of the Master Protocol (LUNGMAP)

The primary objective of this screening study is to test patient specimens to determine eligibility for participation in the biomarker-driven and non-matched sub-studies included within the Lung-MAP umbrella protocol.

Secondary Objectives

  1. Screening Success Rate Objective

To evaluate the screen success rate defined as the percentage of screened patients that register for a therapeutic sub-study. Screen success rates will be evaluated for the total screened population and by the subset of patients screened following progression on previous therapy or pre-screened on current therapy.

2. Translational Medicine Objectives

  1. To evaluate circulating tumor DNA (ctDNA) and compare to the FMI Foundation tissue molecular profiling results in patients who submit a new biopsy for screening.
  2. To establish a tissue/blood repository.

Ancillary Study S1400GEN Objectives

The Lung-MAP Screening Study includes an ancillary study evaluating patient and physician attitudes regarding the return of somatic mutation findings suggestive of a germline mutation. Participation in this study is optional.

  1. Primary Objective

To evaluate patient attitudes and preferences about return of somatic mutation findings suggestive of a germline mutation in the Lung-MAP Screening Study.

2. Secondary Objectives

  1. To evaluate Lung-MAP study physician attitudes and preferences about return of somatic mutation findings suggestive of a germline mutation in the Lung-MAP Screening Study.
  2. To evaluate Lung-MAP patients' and study physicians' knowledge of cancer genomics.
  3. To evaluate Lung-MAP patients' and study physicians' knowledge of the design of the Lung-MAP Screening Study.
  4. To explore whether physician and patient knowledge of cancer genomics and attitudes and preferences about return of genomic profiling findings are correlated.

Clinical Study Identifier: NCT03851445

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Jewish Hospital

Louisville, KY United States
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Saints Mary and Elizabeth Hospital

Louisville, KY United States
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