Clinical Trial 20003

• Overview

  Study Title:

  LungMAP: A Master Protocol to Evaluate Biomarker-Driven Therapies And Immunotherapies In Previously-Treated Non-Small Cell Lung Cancer(Lung-MAP Screening Study)

  Objective:

  Master Protocol (LungMAP) PRIMARY OBJECTIVE 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 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. 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. 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. 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.

• Treatments

  Therapies:

  Therapy (NOS)

  Medications:

  ALT-803 (); AMG 510 (Sotorasib); Alimta (Pemetrexed); Dexamethasone (); Folic Acid (); Gemzar (gemcitabine); IMC-1121B (Ramucirumab); Pembrolizumab (Keytruda); Pemetrexed (); Ramucirumab (); Taxotere (docetaxel); Vitamin B12 (); docetaxel (); gemcitabine ()

• Inclusion Criteria

  > Patients must have pathologically or cytologically proven non-small cell lung cancer. Patients must have Stage IV disease, or recurrent progressive disease without a curative treatment option available. Mixed NSCLC histologies are acceptable, but any known component of small cell lung cancer is not allowed.
  • Patients must either have progression on prior systemic treatment or have received at least 1 dose of systemic treatment as defined below. These criteria are: (a) Screening at progression on prior treatment: To be eligible for screening at progression, patients must have received at least 1 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 therapy was for Stage IV or recurrent disease, the patient must have received at least one line of a platinum-based chemotherapy regimen and/or anti-PD-1/PD-L1 therapy, alone or in combination. For patients whose prior systemic therapy was for Stage I-III disease only (i.e. patient has not received any systemic treatment for Stage IV or recurrent/progressive disease), disease progression on platinum-based chemotherapy must have occurred within 1 year from the last date that patient received that therapy. For patients treated with anti-PD-1 or anti-PD-L1 therapy for Stage I-III disease, disease progression on consolidation anti-PD-1 or anti-PD-L1 therapy must have occurred within 1 year from the date or initiation of such therapy. If disease progression was greater than 1 year after prior therapy, patients must receive subsequent systemic therapy to be eligible. OR Pre Screening prior to progression on current treatment:
  • To be eligible for pre-screening, patients must have received at least 1 dose of a systemic regimen for Stage IV or recurrent/progressive disease and must be prior to progression on this regimen. Patients must have previously received or currently be receiving a platinum-based chemotherapy regimen and/or anti-PD-1/PD-L1 therapy alone or in combination. Note: Patients will not receive their sub-study assignment until the progress and the LUNGMAP Notice of Progression is submitted.
  • Patients must have adequate tumor tissue available to submit on-study or have a prior known commercial FoundationOne CDx tissue-based (not liquid) tumor test for biomarker profiling. All other previous next-generation DNA sequencing (NGS) results will not be accepted.
  • Patients must agree to have this tissue submitted to Foundation Medicine for common broad platform CLIA biomarker profiling. If archival tumor material is exhausted, then a new tumor must be obtained. Patients who need the fresh biopsy must also submit whole peripheral blood for ctDNA testing.
  • Must agree to have any leftover tissue (tissue that that remains after biomarker testing) retained for the use correlative studies outlined in the sub-study treatment consents. OR
  • Submitting commercial FoundationOne CDx results for reanalysis: Must have a FoundationOne CDx report available with the following information: Results done on solid tumor tissue (liquid test not allowed), Original report date on or after September 1, 2019, FMI Test Order number. Patient must consent to have their commercial FoundationOne CDx test results disclosed to SWOG Cancer Research Network.
  • 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 appropriate standard of care therapy/therapies (in the investigator's opinion). 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.
  • Must have Zubrod performance status 0-1 (see Section 10.2) documented within 28 days prior to Step 1 registration.
  • Additional Criteria Apply

• Exclusion Criteria

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