Clinical Trials /

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

NCT03851445

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2/Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Lung-MAP: A Master Screening Protocol for Previously-Treated Non-Small Cell Lung Cancer
  • Official Title: LUNGMAP: A Master Protocol To Evaluate Biomarker-Driven Therapies And Immunotherapies In Previously-Treated Non-Small Cell Lung Cancer (Lung-Map Screening Study)

Clinical Trial IDs

  • ORG STUDY ID: LUNGMAP
  • SECONDARY ID: NCI-2018-01540
  • NCT ID: NCT03851445

Conditions

  • Previously Treated Non-Small Cell Lung Cancer

Interventions

DrugSynonymsArms
Screening PlatformLung-MAP Screening

Purpose

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 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.
    

Trial Arms

NameTypeDescriptionInterventions
Lung-MAP ScreeningOtherThis 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.
  • Screening Platform

Eligibility Criteria

        5.1 Registration

        Step 0:

          1. Patients who need the fresh biopsy must also submit whole blood for ctDNA testing (see
             Section 15.3). These patients must be registered to Step 0 to obtain a patient ID
             number for the submission.

             Patients registered to Step 0 are not registered to the LUNGMAP protocol. To
             participate in LUNGMAP, patients must be registered to Step 1 after evaluation of
             patient eligibility, including tumor tissue adequacy, per protocol Section 5.1, Step
             1.

             Patients registered at Step 0 must use the same SWOG patient ID for registration at
             Step 1.

             Step 1:

          2. 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.

          3. Patients must either be eligible to be screened at progression on prior treatment or
             to be pre-screened prior to progression on current treatment.

             These criteria are:

               1. Screening at progression on prior treatment:

                  To be eligible for screening at progression, patients must have received at least
                  one line of systemic therapy for any stage of disease (Stages I-IV) and must have
                  progressed during or following their most recent line of therapy.

                    -  For patients whose prior systemic therapy was for Stage I-III disease only
                       (i.e. patient has not received any treatment for Stage IV or recurrent
                       disease), disease progression on platinum-based chemotherapy must have
                       occurred within one year from the last date that patient received that
                       therapy. For patients treated with consolidation anti-PD-1 or anti-PD-L1
                       therapy for Stage III disease, disease progression on consolidation
                       anti-PD-1 or anti-PD-L1 therapy must have occurred within one year from the
                       date or initiation of such therapy.

                    -  For patients whose prior therapy was for Stage IV or recurrent disease, the
                       patient must have received at least one line of a platinum-based
                       chemotherapy regimen or anti-PD-1/PD-L1 therapy, alone or in combination
                       (e.g. Nivolumab or Pembrolizumab).

               2. Pre-Screening prior to progression on current treatment:

             To be eligible for pre-screening, current treatment must be for Stage IV or recurrent
             disease and patient must have received at least one dose of the current regimen.
             Patients must have previously received or currently be receiving a platinum-based
             chemotherapy regimen or anti-PD-1/PD-L1 therapy, alone or in combination (e.g.
             Nivolumab or Pembrolizumab). Patients on first-line treatment are eligible upon
             receiving Cycle 1, Day 1 infusion. Note: Patients will not receive their sub-study
             assignment until they progress and the LUNGMAP Notice of Progression is submitted.

          4. Patients must have adequate tumor tissue available, defined as ≥ 20% tumor cells and ≥
             0.2 mm3 tumor volume.

               -  The local interpreting pathologist must review the specimen.

               -  The pathologist must sign the LUNGMAP Local Pathology Review Form confirming
                  tissue adequacy prior to Step 1 registration.

             Patients must agree to have this tissue submitted to Foundation Medicine for common
             broad platform CLIA biomarker profiling, PD-L1, and c-MET IHC (see Section 15.2). If
             archival tumor material is exhausted, then a new fresh tumor biopsy that is
             formalin-fixed and paraffin-embedded (FFPE) must be obtained. Patients who need the
             fresh biopsy must also submit whole peripheral blood for ctDNA testing. A tumor block
             or FFPE slides 4-5 microns thick must be submitted. Bone biopsies are not allowed. If
             FFPE slides are to be submitted, at least 12 unstained slides plus an H&E stained
             slide, or 13 unstained slides must be submitted. However, it is strongly recommended
             that 20 FFPE slides be submitted. Note: Previous next-generation DNA sequencing (NGS)
             will be repeated if done outside this study for sub-study assignment.

             Patients must agree to have any tissue that remains after testing retained for the use
             of sub-study Translational Medicine (TM) studies at the time of consent the patient is
             enrolled in.

          5. Patients with known EGFR sensitizing mutations, EGFR T790M mutation, ALK gene fusion,
             ROS 1 gene rearrangement, or BRAF V600E mutation are not eligible unless they have
             progressed following all standard of care targeted therapy. EGFR/ALK/ROS/BRAF testing
             is not required prior to Step 1 registration, as it is included in the Foundation One
             testing for screening/pre-screening.

          6. Patients must have Zubrod performance status 0-1 (see Section 10.2) documented within
             28 days prior to Step 1 registration.

          7. Patients must be ≥ 18 years of age.

          8. Patients must also be offered participation in banking for future use of specimens as
             described in Section 15.0.

          9. Patients must be willing to provide prior smoking history as required on the LUNGMAP
             Onstudy Form.

         10. As a part of the OPEN registration process (see Section 13.4 for OPEN access
             instructions) the treating institution's identity is provided in order to ensure that
             the current (within 365 days) date of institutional review board approval for this
             study has been entered in the system.

         11. Patients must be informed of the investigational nature of this study and must sign
             and give written informed consent in accordance with institutional and federal
             guidelines.

         12. U.S. patients who can complete the survey and the interview by telephone or email in
             English must be offered participation in the S1400GEN Survey Ancillary Study if local
             institution's policies allow participants to receive the Amazon gift card (see
             Sections 15.7 and 18.5). Patients at institutions that cannot offer the survey must
             still participate in the main study.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Screening Success (Tissue Submission)
Time Frame:Up to 3 years
Safety Issue:
Description:The tissue submission will be measured by the proportion of patients who register to this screening study for whom a tissue sample is submitted.

Details

Phase:Phase 2/Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Southwest Oncology Group

Last Updated

August 11, 2020