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Trial Summary


Protocol No.CTO-LUNGMAP
StatusOPEN TO ACCRUAL
Principal InvestigatorJalal, Shadia
ScopeNational
PhasePhase II/III
Age GroupAdult
TitleA MASTER PROTOCOL TO EVALUATE BIOMARKER-DRIVEN THERAPIES AND IMMUNOTHERAPIES IN PREVIOUSLY-TREATED NON-SMALL CELL LUNG CANCER (Lung-MAP Screening Study)
DescriptionThis 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 Eligibility

In order to be eligible to take part in this trial, patients must meet the following criteria:

  • Patients must have pathologically proven non-small cell lung cancer (all histologic types) confirmed by tumor biopsy and/or fine-needle aspiration. Disease must be Stage IV as defined in Section 4.0, or recurrent. The primary diagnosis of non-small cell lung cancer should be established using the current WHO/IASLC-classification of Thoracic Malignancies. All histologies, including mixed, are allowed.
  • Patients must have adequate tumor tissue available, defined as ≥ 20% tumor cells and ≥ 0.2 mm3 tumor volume.

For a full list of participation criteria, please visit clinicaltrials.gov.

Applicable Disease SitesLung
Participating InstitutionsIndiana University (IU)
    Roudebush VA Medical Center
      Treatment TypeTreatment
      ContactPhone: (317) 278-5632
      Email: iutrials@iu.edu