Biomarker-Driven Therapy and Immunotherapy in Screening Participants with Recurrent or Stage IV Non-Small Cell Lung Cancer (The Expanded Lung-MAP Screening Trial)
This expansion of the screening and multi-sub-study Lung-MAP trial is motivated by the changing landscape due to progress in the development of immunotherapies. The Lung-MAP trial was originally opened in June of 2014 for second-line treatment of participants with stage IV squamous lung cancer or squamous lung cancer that has come back (recurrent). The trial was amended to allow all participants with previously-treated stage IV or recurrent squamous lung cancer in 2015. The study is now expanding to allow participants with all types of previously-treated stage IV or recurrent non-small cell lung cancer. The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned in order to compare new targeted cancer therapy designed to block the growth and spread of cancer, 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 participants not eligible for any of the biomarker-driven sub-studies.
Eligibility
Inclusion Criterea
- Patients must have pathologically or cytologically proven non-small cell lung cancer (NSCLC; all histologic types). 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 one dose of systemic treatment as defined below. These criteria are:
* 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 screening patients with known RET fusion positive NSCLC see S1900F
*** For patients whose prior therapy was for Stage IV or recurrent disease, the patient must have received at least one line of a standard of care therapy for Stage IV or recurrent disease (See current NCCN guidelines)
*** For patients who received adjuvant chemotherapy, progression must have occurred within one year from last date that patient received that therapy. For patients receiving adjuvant osimertinib, disease progression must have occurred on osimertinib. 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 one year form the date of initiation of such therapy. If disease progression was greater than one year after prior therapy, patients much receive subsequent systemic therapy to be eligible.
*** 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 one 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 one year from the date of initiation of such therapy. If disease progression was greater than one 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 one dose of a systemic regimen for Stage IV or recurrent/progressive disease and must be prior to progression on this regimen.
*** Patients must have received or currently be receiving a first-line standard of care therapy.
*** It is strongly recommended that patients receiving osimertinib do not pre-screen due to the S1900G eligibility
**** Note: Patients will not receive their sub-study assignment until they progress and the LUNGMAP Notice of Progression is submitted.
* Patients must meet one of the following criteria:
** Patient has adequate tissue available to submit for on-study biomarker profiling
*** For patients with known EGFR mutation positive NSCLC that are screening for entry into S1900G, the tissue specimen must have been obtained after radiographic or clinical progression on osimertinib
** Patient has prior commercial FoundationOne CDx tissue-based (not liquid) tumor test results
*** Note: For patients with known EGFR mutation positive, MET amplification positive NSCLC that are screening for entry into S1900G, the tissue specimen must have been obtained after radiographic or clinical progression on osimertinib
** Patient has documentation of prior known EGFR mutation positive, MET amplification positive NSCLC
** Patient has documentation of prior known MET exon 14 skipping positive NSCLC
* Submitting tissue for on-study biomarker profiling:
** Patients must have adequate tumor tissue available, defined as >= 20% tumor cells and >= 0.2 mm^3 tumor volume.
Specimens from bone biopsy are not allowed unless the specimen is entirely soft tissue or has not been decalcified. All other sites of tumor are acceptable, given the specimen meets all requirements for tissue adequacy.
A formalin-fixed and paraffin-embedded (FFPE) tumor block or unstained FFPE slides 4-5 microns thick must be submitted. If slides are to be submitted, at least 12 unstained slides plus an H&E-stained slide, or 13 unstained slides must be submitted. However, if slides are to be submitted, it is strongly recommended that 20 unstained slides be submitted.
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 biopsy must be obtained.
Patients must agree to have any leftover tissue (tissue that remains after biomarker testing) retained for the use of correlative studies outlined in the sub-study consents.
* OR
** Submitting commercial FoundationOne CDx results for reanalysis:
*** Patients 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 # (e.g., ORD-1234567-01)
Patients must consent to have their commercial FoundationOne CDx test results disclosed to SWOG Cancer Research Network.
- Patients must meet one of the following criteria:
* Patient has adequate tissue available to submit for on-study biomarker profiling
** Note: For patients with known EGFR-mutant NSCLC that are screening for entry into S1900G, the tissue specimen must have been obtained after radiographic or clinical progression on osimertinib.
* Patient has prior commercial FoundationOne CDx tissue-based (not liquid) tumor test results
** Note: For patients with known EGFR-mutant, MET amplified NSCLC that are screening for entry into S1900G, the tissue specimen must have been obtained after radiographic or clinical progression on osimertinib.
* Patient has documentation of prior known EGFR-mutant, MET amplified NSCLC.
* Submitting tissue for on-study biomarker profiling:
** Patients must have adequate tumor tissue available, defined as >= 20% tumor cells and >= 0.2 mm^3 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 registration.
** Specimens from bone biopsy are not allowed unless the specimen is entirely soft tissue or has not been decalcified. All other sites of tumor are acceptable, given the specimen meets all requirements for tissue adequacy.
** A formalin-fixed and paraffin-embedded (FFPE) tumor block or unstained FFPE slides 4-5 microns thick must be submitted. If slides are to be submitted, at least 12 unstained slides plus a hematoxylin and eosin (H&E)-stained slide, or 13 unstained slides must be submitted. However, if slides are to be submitted, it is strongly recommended that 20 unstained slides be submitted.
** Patients must agree to have this tissue submitted to Foundation Medicine for common broad platform Clinical Laboratory Improvement Act (CLIA) biomarker profiling
** If archival tumor material is exhausted, then a new tumor biopsy must be obtained.
** Patients must agree to have any leftover tissue (tissue that remains after biomarker testing) retained for the use of correlative studies outlined in the sub-study consents.
* OR
* Submitting commercial FoundationOne CDx results for reanalysis:
** Patients 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 # (e.g., ORD-1234567-01)
*** Patients must consent to have their commercial FoundationOne CDx test results disclosed to SWOG Cancer Research Network
- Patients’ most recent Zubrod performance status must be 0-1 and be documented within 28 days prior to registration
- Patients must be >= 18 years of age
- Patients must also be offered participation in banking for future use of specimens
- Patients must be willing to provide prior smoking history as required on the LUNGMAP On-study Form
- As a part of the OPEN registration process, 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
- 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
Participating Clinics
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
GenesisCare USA - Henderson
Comprehensive Cancer Centers of Nevada-Horizon Ridge
OptumCare Cancer Care at MountainView
Hope Cancer Care of Nevada
Las Vegas Cancer Center-Medical Center
OptumCare Cancer Care at Charleston
Hope Cancer Care of Nevada-Pahrump
OptumCare Cancer Care at Seven Hills
Renown Regional Medical Center
Saint Mary's Regional Medical Center
Comprehensive Cancer Centers of Nevada - Central Valley
Comprehensive Cancer Centers of Nevada
Radiation Oncology Associates
Radiation Oncology Centers of Nevada Central
Comprehensive Cancer Centers of Nevada - Northwest
Radiation Oncology Centers of Nevada Southeast
GenesisCare USA - Fort Apache
GenesisCare USA - Vegas Tenaya
OptumCare Cancer Care at Fort Apache
HealthCare Partners Medical Group Oncology/Hematology-San Martin
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Comprehensive Cancer Centers of Nevada-Summerlin
Comprehensive Cancer Centers of Nevada - Henderson
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
GenesisCare USA - Las Vegas
Las Vegas Cancer Center-Henderson
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Comprehensive Cancer Centers of Nevada - Town Center
Kingman Regional Medical Center
Urology Specialists of Nevada - Southwest
Las Vegas Urology - Cathedral Rock
Urology Specialists of Nevada - Green Valley
Las Vegas Urology - Green Valley
Las Vegas Urology - Pebble
Las Vegas Urology - Sunset
Urology Specialists of Nevada - Northwest
Las Vegas Urology - Pecos
Urology Specialists of Nevada - Central