A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
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Eligibility Criteria Expand/Collapse
a. Patients must have pathologically proven squamous cell carcinoma (SCCA) cancer of the lung confirmed by tumor biopsy and/or fine-needle aspiration. Disease must be Stage IV SCCA as defined in Section 4.0, or recurrent. The primary diagnosis of SCCA should be established using the current WHO/IASLC-classification of Thoracic Malignancies. The diagnosis is based on H&E stained slides with or without specific defined IHC characteristic (p40/p63 positive, TTF1 negative) if required for diagnosis. Mixed histologies are not allowed.
b. Patients must either be eligible to be screened at progression on prior treatment or to be pre-screened prior to progression on current treatment. Patients will either consent to the Screening consent or the Pre-Screening consent, not both. These criteria are:
1. 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 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), the prior systemic therapy must have been a platinum-based chemotherapy regimen and disease progression on the platinum-based chemotherapy must have occurred within one year from the last date that patient received that 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 checkpoint inhibitor therapy (e.g. Nivolumab or Pembrolizumab).
2. 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 checkpoint inhibitor therapy (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 S1400 Notice of Progression is submitted.
c. Patients must have adequate tumor tissue available, defined as >= 20% tumor cells and >= 0.2 mm3 tumor volume.
â€¢ The local interpreting pathologist must review the specimen.
â€¢ The pathologist must sign the S1400 Local Pathology Review Form confirming tissue adequacy prior to screening/pre-screening registration.
Patients must agree to have this tissue submitted to Foundation Medicine for common broad platform CLIA biomarker profiling and c-Met IHC (see Section 15.1). If archival tumor material is exhausted, then a new fresh tumor biopsy that is formalin-fixed and paraffin-embedded (FFPE) must be obtained. 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.
Patients must agree to have any tissue that remains after NGS testing retained for the use of the Translational Medicine (TM) studies (if such TM studies are defined) within any sub-study the patient is enrolled in.
d. Patients must not have a known EGFR mutation, or ALK fusion. EGFR/ALK testing is not required prior to registration and is included in the FMI testing for screening/prescreening.
e. Patients must have Zubrod performance status 0-1 (see Section 10.4) documented within 28 days prior to screening/pre-screening registration.
f. Patients must be >= 18 years of age.
g. Patients must also be offered participation in banking for future use of specimens as described in Section 15.0.
h. Patients must be willing to provide prior smoking history as required on the S1400 Onstudy Form.
i. As a part of the OPEN registration process (see Section 13.4 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.
j. 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.
k. U.S. patients who can complete the survey and the interview by telephone or email in English must be offered participation in the S1400GEN Survey Ancillary Study (see Sections 15.5 and 18.1f). NOTE: Patients enrolled to S1400 prior to Revision #12 are not eligible for the S1400GEN Survey Ancillary Study. Study physicians will provide participants with a hard copy of the survey (at the time of informed consent) to improve tracking and comprehension during the interview.
See substudies for individual substudy additional eligibility criteria.
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