IRB Study Number LUNGMAP-Mercy
Status Recruiting
Institute Taussig Cancer Institute
Description
1.1 Primary Objective of the Master Protocol (LUNGMAP)
To test patient specimens to determine eligibility for participation in the biomarker-driven and non-matched substudies included within the Lung-MAP umbrella protocol.
1.2 Secondary Objectives
a. 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.
b. Translational Medicine Objectives
- To establish a tissue/blood repository.
Inclusion Criteria
5.1 Disease Related and General Criteria
a. Participants must have pathologically or cytologically proven non-small cell lung cancer (NSCLC). Mixed histologic subtypes of NSCLC are acceptable, but any known component of small cell lung cancer is not allowed.
b. Participants must have Stage IV NSCLC, or recurrent or progressive NSCLC without a curative treatment option available.
c. Participants must be ≥ 18 years of age.
d. Participants’ most recent Zubrod/ECOG performance status must be 0–2 and be documented within 28 days prior to registration.
e. Participants must be eligible to be Pre-Screened prior to progression (see Section 5.2) or Screened at Progression (see Section 5.3).
5.2 Pre-Screening Eligibility Criteria
a. To be eligible to be pre-screened, participants must have tumor tissue available for on-study biomarker profiling and must meet both of the following criteria:
1) Participants must be prior to progression on their current or most recent systemic treatment for Stage IV or recurrent/progressive NSCLC, AND
2) Participants must have previously received or currently be receiving a first-line standard of care therapy for Stage IV or recurrent/progressive NSCLC.
Participants may have received multiple lines of therapy for Stage IV or recurrent/progressive NSCLC.
NOTE: Participants using previously completed biomarker test are not eligible to be Pre-Screened and must only register to be Screened at Progression. See Section 5.3.
Sub-study assignments are provided for Pre-Screened participants when the LUNGMAP Notice of Progression Form is submitted in RAVE.
Participants receiving osimertinib interested in participating in S1900G must not be pre-screened and will need a post-progression assessment of MET amplification status (on tissue or blood) due to the S1900G eligibility (see S1900G section 5.1.c).
5.3 Screening at Progression Eligibility Criteria
a. To be eligible to be screened at progression, participants must meet the following criteria for prior treatment of NSCLC. Specifically, participants:
1) Must have received at least one line of systemic standard of care therapy for Stage I-IV NSCLC, AND
2) Must have progressed during or following their most recent line of systemic therapy for NSCLC, AND
3) If participant has not received any prior systemic therapy for Stage IV or recurrent/progressive NSCLC, disease progression on prior systemic therapy for Stage I-III disease must have occurred within (≤) 180 days from the last date that participant received that therapy.
If disease progression was greater than (>) 180 days after the last dose of therapy for stage I-III disease, participants must receive standard-of-care therapy for stage IV or recurrent/progressive disease and experience disease progression during or after this therapy to be eligible.
b. To be eligible to be screened at progression, participants must meet one of the following criteria for biomarker testing:
1) have tumor tissue available for on-study biomarker profiling, OR
2) have documentation of a previously completed Next Generation Sequencing (NGS) test on the list of approved tests (see the LUNGMAP NGS Testing Reference Page at http://www.swog.org/lung-map-resources), OR
3) have documentation of a previously completed NGS test not on the list of approved tests, have submitted a report to LUNGMAPNGS@swog.org for review, and have an e-mail documenting the test is acceptable (see Section 15.4), OR
4) Have documentation of the presence of a specific biomarker (or set of biomarkers) for one of the biomarker-driven sub-studies open at the time of registration and have submitted a report to LUNGMAPNGS@swog.org with an e-mail documenting that the test is acceptable (see Section 15.4).
NOTE: For participants 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.
5.4 Specimen Submission for On-Study Biomarker Profiling Criteria
a. For participants submitting tissue for on-study biomarker profiling, all of the following criteria must be met:
• A formalin-fixed and paraffin-embedded (FFPE) tumor block, or at least 12 unstained slides plus an H&E-stained slide or 13 unstained FFPE slides 4-5 microns thick must be available for submission, AND
• Participants must agree to have this tissue submitted to Foundation Medicine for common broad platform CLIA biomarker profiling (see Section 15.3a), AND
• Participants must agree to have any leftover tissue (tissue that remains after biomarker testing) retained for the use of future correlative studies, AND
• The tumor sample must have ≥ 20% tumor cells and ≥ 0.2 mm3 tumor volume, AND
• The tumor sample must not be from a bone biopsy 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.
NOTE: Liquid specimens like pleural fluid are acceptable if they meet cellularity requirements and are mounted on an FFPE block.
5.5 Prior Biomarker Test Submission Criteria
a. For participants providing documentation of a previously completed test on the list of approved tests/laboratories, ALL of the following criteria must be met:
• The full biomarker report must be available to upload as source documentation in RAVE.
• The report must provide documentation of the following:
O That the test was done on solid tumor tissue or blood (indicating which)
O That the original report date on or after September 1, 2019.
• The participant must have consented to have these test results disclosed to SWOG Cancer Research Network (see Section 15.4).
b. For participants providing documentation of a previously completed test NOT on the list of approved labs, the test and associated documentation must meet ALL the following criteria:
• The full biomarker report must be available to upload as source documentation in RAVE.
• The test must have been performed within a laboratory with CLIA, ISO/IEC, CAP, or similar certification.
• The report must show that the test was done on solid tumor tissue or blood (indicating which).
• The full list of genes included in the test must either be documented on the report or documented separately.
• The report must show that the original report date was on or after September 1, 2019
• The report and associated documentation must have been submitted to LUNGMAPNGS@swog.org for review and an e-mail response must have been received documenting that the test is acceptable (see Section 15.4)
• The participant must have consented to have these test results disclosed to SWOG Cancer Research Network (see Section 15.4).
c. For participants with a previously completed NGS test based on blood only, the test must provide documentation of the presence of at least one of the alterations listed on the LUNGMAP Genomic Alterations Form.
If the report for blood-based NGS does not document the presence of at least one of these alterations, the participant is not eligible. To be eligible, the participant must either submit documentation of an approved tissue-based NGS test or submit tissue for on-study biomarker testing.
5.6 Regulatory Criteria
a. Participants 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.
NOTE: As a part of the OPEN registration process (see Section 13.3 for OPEN access instructions) 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.
Exclusion Criteria
Exclusion Criteria Not Available
