Title
A Master Protocol to Evaluate Biomarker-Driven Therapies and Immunotherapies in Previously-Treated Non-Small Cell Lung Cancer

Description
A Master Protocl to Evaluate Biomarker-Driven Therapies and Immunotherapies in Previously treated Non-Small Cell Lung Cancer

Objective
We are doing this study because we want to find out if a targeted or immunotherapy treatment will have an effect on specific genes and proteins in your tumor

Treatment 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

Key Eligibility
Step 0: Patients who need the fresh biopsy must also submit whole blood for ctDNA testing: To participate in LungMAP, patients must be registered to Step 1 after evaluation of patient eligibility, including tumor tissue adequacy, per protocol

Step 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.
The primary diagnosis of non-small cell lung cancer should be established using the current WHO/IASLC-classification of Thoracic Malignancies

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

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

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 platinumbased 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 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)

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

Patients must have adequate tumor tissue available as defined by the protocol, and must agree to have this tissue submitted to Foundation Medicine

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

Patients must have Zubrod performance status 0-1

Patients must be 18 years of age or older

Patients must be willing to provide prior smoking history

Applicable Disease Sites
Lung

Participating Institutions
Mercy Health Systems, Janesville ; Mercy Health, Javon Bea - Rockford; UW Health 1 S. Park Medical Center; UW Health Eastpark Medical Center; UW Health University Hospital