NCI ID NCI-2018-01540
NCT ID NCT03851445
CTEP ID LUNGMAP
Primary Purpose SCREENING
Anatomic Sites Lung
Minimum Age 18 Years
Maximum Age 999 Years
Gender BOTH
Lead Org SWOG
Principal Investigator Hossein Borghaei
NCI Site View on ClinicalTrials.gov

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 patients with a known RET fusion screening for entry to S1900F: **** Patients must have received and developed disease progression during or after an anti-RET inhibitor treatment. The anti-RET inhibitor therapy must be the most recent therapy. **** For patients with Stage IV or recurrent disease, the patient must not have received a platinum-based chemotherapy regimen. **** 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 not have occurred within one year (365 days) from the last date that the patient received that therapy. Prior anti-PD-1/PD-L1 therapy, alone or in combination (e.g., Nivolumab, Pembrolizumab, or Durvalumab) is allowed. *** For patients with a known EGFR mutation that are screening for entry on S1900G: **** Submitting prior known MET amplification results: ***** Patient must have documentation of a sensitizing EGFR mutation and MET amplification as determined by ****** A tissue-based next generation sequencing (NGS) assay OR ****** Blood-based [circulating tumor deoxyribonucleic acid (DNA) (ctDNA)] assay ***** EGFR documentation does not need to be from the same timepoint as MET amplification, however MET amplification must be present in the tumor or blood sample taken at the time of disease progression on osimertinib. ***** The testing must be done within within a laboratory with CLIA, International Organization for Standardization/International Electrotechnical Commission (ISO/IEC), College of American Pathologists (CAP), or similar certification. ***** Tissue or blood must be obtained after radiographic or clinical disease progression on osimertinib (alone or in combination with another agent(s)), as the most recent line of therapy. ***** Patients must submit tumor tissue if available. The tissue must be from a biopsy performed at the time of disease progression on the most recent line of therapy. An additional biopsy is not required to obtain this tissue if it is not already available. Note: Patients with prior commercial FoundationOne CDx tissue-based (not liquid) tumor test results [obtained after radiographic or clinical disease progression on osimertinib (alone or in combination with another agent(s)), as the most recent line of therapy ] do not need to submit tumor tissue **** 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 National Comprehensive Cancer Network [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 ** 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

Exclusion Criterea


Participating Clinics

North Star Lodge Cancer Center at Yakima Valley Memorial Hospital


808 North 39th Avenue
Yakima, WA 98902
Map

509-574-3535
Memorial-ClinicalTrials@yvmh.org

Comprehensive Cancer Centers of Nevada - Northwest


7445 Peak Drive
Las Vegas, NV 89128
Map

702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada-Horizon Ridge


2460 West Horizon Ridge Parkway
Henderson, NV 89052
Map

702-384-0013
research@sncrf.org

Kingman Regional Medical Center


3269 Stockton Hill Road
Kingman, AZ 86401
Map

702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada - Town Center


653 North Town Center Drive
Suite 402 Las Vegas, NV 89144
Map

702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada - Henderson


10001 South Eastern Avenue
Suite 108 Henderson, NV 89052
Map

702-384-0013
research@sncrf.org

Ann M Wierman MD LTD


3150 Tenaya Way
Suite 200 Las Vegas, NV 89128
Map

702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada-Southeast Henderson


1505 Wigwam Parkway
Suite 130 Henderson, NV 89074
Map

702-384-0013
research@sncrf.org

HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills


6850 North Durango Drive
Suite 120 Las Vegas, NV 89149
Map

702-384-0013
research@sncrf.org

OptumCare Cancer Care at MountainView


3150 North Tenaya Way
Suite 510 Las Vegas, NV 89128
Map

702-384-0013
research@sncrf.org

Radiation Oncology Centers of Nevada Southeast


3980 South Eastern Avenue
Las Vegas, NV 89119
Map

702-384-0013
research@sncrf.org

GenesisCare USA - Fort Apache


6160 South Fort Apache Road
Las Vegas, NV 89148
Map

702-384-0013
research@sncrf.org

GenesisCare USA - Vegas Tenaya


2851 North Tenaya Way
Suite 100 Las Vegas, NV 89128
Map

702-384-0013
research@sncrf.org

OptumCare Cancer Care at Fort Apache


6190 South Fort Apache Road
Las Vegas, NV 89148
Map

702-384-0013
research@sncrf.org

HealthCare Partners Medical Group Oncology/Hematology-San Martin


8285 West Arby Avenue
Suite 100 Las Vegas, NV 89113
Map

702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada-Summerlin


655 North Town Center Drive
Las Vegas, NV 89144
Map

702-384-0013
research@sncrf.org

Hope Cancer Care of Nevada


6827 West Tropicana Avenue
Suite 110 Las Vegas, NV 89103
Map

702-384-0013
research@sncrf.org

Radiation Oncology Associates


6630 B South McCarran
Suite 18 Reno, NV 89509
Map

702-384-0013
research@sncrf.org

PCR Oncology


584 Camino Mercado
Arroyo Grande, CA 93420
Map

702-384-0013
research@sncrf.org

OptumCare Cancer Care at Charleston


2300 West Charleston Boulevard
Las Vegas, NV 89102
Map

702-384-0013

Radiation Oncology Centers of Nevada Central


624 South Tonopah Drive
Las Vegas, NV 89106
Map

702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada


9280 West Sunset Road
Suite 100 Las Vegas, NV 89148
Map

702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada - Central Valley


3730 South Eastern Avenue
Las Vegas, NV 89169
Map

702-384-0013
research@sncrf.org

Saint Mary's Regional Medical Center


235 West Sixth Street
Reno, NV 89503
Map

702-384-0013
research@sncrf.org

HealthCare Partners Medical Group Oncology/Hematology-Tenaya


2851 North Tenaya Way
Suite 101 Las Vegas, NV 89128
Map

702-384-0013
research@sncrf.org

GenesisCare USA - Las Vegas


3006 South Maryland Parkway
Suite 100 Las Vegas, NV 89109
Map

702-384-0013
research@sncrf.org

Renown Regional Medical Center


1155 Mill Street
Reno, NV 89502
Map

702-384-0013
research@sncrf.org

Hope Cancer Care of Nevada-Pahrump


2340 East Calvada Boulevard
Suite 7 Pahrump, NV 89048
Map

702-384-0013
research@sncrf.org

Las Vegas Cancer Center-Medical Center


6450 Medical Center Street
Las Vegas, NV 89148-2405
Map

702-384-0013
research@sncrf.org

OptumCare Cancer Care at Seven Hills


3175 Saint Rose Parkway
Suite 200 Henderson, NV 89052
Map

702-384-0013
research@sncrf.org

GenesisCare USA - Henderson


52 North Pecos Road
Henderson, NV 89074
Map

702-384-0013
research@sncrf.org

Las Vegas Cancer Center-Henderson


2904 West Horizon Ridge Parkway
Suite 200 Henderson, NV 89052
Map

702-384-0013
research@sncrf.org

Urology Specialists of Nevada - Southwest


8410 West Warm Springs Road
Suite 10 Las Vegas, NV 89113
Map


research@sncrf.org

Las Vegas Urology - Pecos


9053 South Pecos Road
Suite 2900 Las Vegas, NV 89074
Map


research@sncrf.org

Las Vegas Urology - Green Valley


1701 North Green Valley Parkway
Suite 10C Henderson, NV 89074
Map


research@sncrf.org

Urology Specialists of Nevada - Northwest


3150 North Tenaya Way
Suite 165 Las Vegas, NV 89128
Map


research@sncrf.org

Urology Specialists of Nevada - Central


2010 Wellness Way
Suite 200 Las Vegas, NV 89106
Map


research@sncrf.org

Urology Specialists of Nevada - Green Valley


58 North Pecos Road
Henderson, NV 89074
Map


research@sncrf.org

Las Vegas Urology - Cathedral Rock


7200 Cathedral Rock Drive
Suites 180 and 210 Las Vegas, NV 89128
Map


research@sncrf.org

Las Vegas Urology - Sunset


7150 West Sunset Road
Suite 201A and 202B Las Vegas, NV 89113
Map


research@sncrf.org

Las Vegas Urology - Pebble


8915 South Pecos Road
Suite 19A Henderson, NV 89074
Map


research@sncrf.org

Valley Medical Center


400 South 43rd Street
Renton, WA 98055
Map

425-228-3440
research@valleymed.org