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
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.
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
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.
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.
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
To evaluate Lung-MAP study physician attitudes and preferences about return of
somatic mutation findings suggestive of a germline mutation in the Lung-MAP
To evaluate Lung-MAP patients' and study physicians' knowledge of cancer genomics.
To evaluate Lung-MAP patients' and study physicians' knowledge of the design of the
Lung-MAP Screening Study.
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
Southwest Oncology Group
Last Modified on
17 November 2020
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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