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

Conditions

• Previously Treated Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Screening Platform — DRUG
  The screening study tests patient specimens to determine eligibility for participation in the biomarker-driven and non-matched sub-studies included within the Lung-MAP umbrella protocol.

Study Details

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.

Key Dates

Start date

Feb 6, 2019

Status verified

May 2026

Primary completion

Jan 28, 2029

Completion

Jan 28, 2029

Study Design

Enrollment

10,000 participants (estimated)

Allocation

NA

Intervention model

SEQUENTIAL

Primary purpose

SCREENING

Arms

• Other: Lung-MAP Screening
  This is a screening study and does not have an intervention. LUNGMAP is an overarching umbrella study to which patients are screened and then assigned to a treatment sub-study. The treatment sub-studies are standalone trials and have their own NCT numbers. The Lung-MAP Study is considered a single study under one IND, consisting of the Screening Protocol and multiple sub-studies. Each sub-study protocol operates independently and has its own version date.

Primary Outcome Measure

Screening Success (Tissue Submission) [ Time Frame: Up to 3 years ]

Central Contacts

• Jennifer Beeler
  2106148808
  [email protected]
• SWOG Protocols
  210-614-8808
  [email protected]

Locations (1229)