Lung Cancer SWOG-1400

May 09, 2017

Sponsor: Southwest Oncology Group

Number: SWOG-1400

Eligible patients who enroll in the study will be randomly assigned (by chance) to this screening and multi-sub-study phase II/III trial (Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety. Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely) will establish a method for genomic screening (a type of medical test that identifies changes in chromosomes, genes, or proteins) of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid "Master Protocol" (S1400). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned. This study is used to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a "non-match" sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.

Who’s eligible:

• Patients must have pathologically proven squamous cell carcinoma (SCCA a histological subtype of non-small cell lung cancer) cancer of the lung confirmed by tumor biopsy and/or fine-needle aspiration. Disease must be stage IV (the development of secondary malignant growths at a distance from a primary site of cancer) SCCA, or recurrent (cancer that has returned).
• 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 I-IV, Click here for lung cancer staging definitions). At least one of these lines of therapy must have been a platinum-based 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.The patient’s doctor will be able to tell the patient what type of chemotherapy they are receiving, and whether the chemotherapy is platinum-based or not.
  • 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.
• This study is for patients age 18 and older.

Available at: The Hospital of Central Connecticut, Backus Hospital, MidState Medical Center, and Hartford Hospital.