NCI Community Oncology Research Program - Kansas City (NCORP-KC)
NCI Community Oncology Research Program - Kansas City (NCORP-KC)




NCI Community Oncology Research Program - Protocol Summary

SWOG S1400 - "A Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer"(Lung-Map)

The summary below serves as a brief review of the treatment plan and eligibility for the protocol.


This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
 

Please follow the "Full Protocol" link or contact KCCOP for complete protocol information.



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Lung Clinical Trial

CANCER TYPE: Non-Small Cell - Stage IV
RESEARCH BASE: SWOG S1400
NCT NUMBER: NCT02154490
HIPPA FORM: DOWNLOAD HIPPA FORM

Consent Form: VIEW CONSENT FORM
Additional Consent Form: VIEW CONSENT FORM 2

BRIEF DESCRIPTION

Squamous cell lung ca, Stg IV or recurrent, 1 prior front-line platinum-based chemo regimen w/disease progression; CLIA Biomarker Profiling ---> sub-study assignments based on results. Mandatory tissue submission & Central Review of scans.  DCP-001 Eligible



NOTES


NOTES: 

1)  Mandatory online video training is available at: https://swog.org/Members/Training/S1400Training.asp.  At least 1 person from each site must complete training b/f enrolling patients.

2)  Tissue for biomarker profiling must be submitted within ONE working day of S1400 screening/pre-screening registration.

2)  Contact NCORP-KC with funding questions.

3)  Sub-study E is permanently closed

4)  Sub-study A is permanently closed

5)  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.

 

SCREENING/PRE SCREENING REGISTRATION

MANDATORY Common Broad Platform CLIA Biomarker Profiling (archival FFPE tumor, fresh core needle bx if needed)

SUB-STUDY ASSIGNMENT (S1400B, S1400C, S1400D, S1400I)

 

 

 

 

 

 

 

 

 



ELIGIBILITY

Screening/Pre-Screening

  • 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/IASLCclassification of Thoracic Malignancies. (9) 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.
  • 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:
    • 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).  At least one of these lines of therapy must have been a platinumbased chemotherapy regimen. Patients must have progressed following the 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 disease), disease progression on platinum-based chemotherapy must have occurred within one year from the last date that patient received that therapy.
    • Pre-Screening prior to progression on current treatment:
      To be eligible for pre-screening, current treatment must be for Stage IV 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. Patients on first-line platinum-based 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.
  • Patients must have adequate tumor tissue available, defined as ≥ 20% tumor cells and ≥ 0.2 mm3 tumor volume. The local interpreting pathologist must review and sign off on the S1400 Local Pathology Review Form prior to screening/prescreening registration. Patients must agree to have this tissue submitted to Foundation Medicine for common broad platform CLIA biomarker profiling (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 not have a known EGFR mutation or ALK fusion.
  • Patients must have Zubrod performance status 0-1 (see Section 10.4) documented within 28 days prior to screening/pre-screening registration.
  • Patients must be ≥ 18 years of age.
  • Patients must also be offered participation in banking for future use of specimens as described in Section 15.0.
  • Patients must be willing to provide prior smoking history as required on the S1400 Onstudy Form.
  • 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.

 






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