A Master Protocol to Evaluate Biomarker-Driven Therapies and Immunotherapies in Previously-Treated Non-Small Cell Lung Cancer (Lung Map Screening Study)

PROTOCOL: Lung Map

SCHEMA LUNG MAP

Please Note: Below is partial list of eligibility, for full eligibility requirement’s, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!

ELIGIBILITY:

Step 0:

1. Patients with adequate archival tissue should be registered directly to Step 1, without registering to Step 0. Patients who need a fresh biopsy to obtain adequate tumor tissue must also submit whole blood for ctDNA testing. These patients must be registered to Step 0 to obtain a patient ID number for the submission.
2. 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.

Step 1:

1. 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 or recurrent. All histologies, including mixed, are allowed.
2. Patients must either be eligible to be screened at progression on prior treatment or to be pre-screened prior to progression on current treatment.
3. 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 IIV) and must have progressed during or following their most recent line of therapy.
   1. 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-PD1 or anti-PD-L1 therapy must have occurred within one year from
      the date of initiation of such therapy.
   2. 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).
4. 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/PDL1 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.
5. 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.
6. Patients must agree to have this tissue submitted to Foundation Medicine for common broad platform CLIA biomarker profiling and PD-L1. 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.
7. Patients must agree to have any leftover tissue (tissue that remains after biomarker testing) retained for the use of correlative studies outlined in the substudy treatment consents.
8. 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/prescreening.
9. Patients must have Zubrod performance status 0-1.
10. Patients must be ≥ 18 years of age.