Clinical Trial Information
PROTOCOL: SWOG-S1800A (Lung Map Non-Matched Sub-Study)
Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.
- Patients must have been assigned to S1800A by the SWOG Statistics and Data Management Center (SDMC). Patients who were screened under S1400 (legacy screening/pre-screening study) must have had prior PD-L1 testing by the Dako 22C3 PharmDx IHC assay, and must have results available for stratification purposes.
- Patients must not have EGFR sensitizing mutations, EGFR T790M mutation, ALK gene fusion, ROS 1 gene rearrangement, and BRAF V600E mutation unless they have progressed following all standard of care targeted therapy.
- Patients must not have an active autoimmune disease that has required systemic treatment in past two years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g.,thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is
- Patients must not have any history of primary immunodeficiency.
- Patients must not have undergone major surgery within 28 days prior to sub-study randomization, or subcutaneous venous access device placement within 7 days prior to randomization. Any patient with postoperative bleeding complications or wound complications from a surgical procedure performed in the last two months should be excluded. The patient must not have elective or planned major surgery to be performed during the course of the clinical trial.
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years.
- Patients must have received at least one line of anti-PD-1 or anti-PD-L1 therapy for Stage III, IV or recurrent disease and at most one line of anti-PD-1 or anti-PDL1 therapy for Stage IV or recurrent disease, given alone or in combination with platinum-based chemotherapy, an anti-CTLA4 therapy, or other immunemodulatory therapy. Patients must have experienced disease progression during or after this regimen. Disease progression during or after anti-PD-1 or anti-PD-L1 therapy must have occurred more than (>) 84 days following initiation (Cycle 1 Day 1) of anti-PD-1 or PD-L1 therapy (combination or monotherapy).
- Patients who received consolidation anti-PD-1 or anti-PD-L1 therapy following concurrent chemoradiation for Stage III disease as their only line of anti-PD-1 or anti-PD-L1 therapy, are eligible if they experienced disease progression more than (>) 84 days but less than (<) 365 days from their first date of anti-PD-1 or anti-PDL1 therapy.
- Patients must have been exposed to platinum-based chemotherapy. Patients who did not receive platinum-based chemotherapy in combination with anti-PD-1 or anti-PD-L1 therapy must have received platinum-based chemotherapy separately and experienced disease progression during or after this regimen.
- For patients who only received prior adjuvant platinum-based therapy post-surgical resection for Stage I-III disease (i.e. the patient has not received platinum-based chemotherapy for Stage IV or recurrent disease), disease progression on platinumbased chemotherapy must have occurred within one year from the last dose that the patient received that therapy.
- Prior tyrosine kinase inhibitor therapy for patients with targetable alterations is allowed if criteria above is also met.
- Patients must have progressed (in the opinion of the treating investigator) following the most recent line of therapy.
- Patients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to substudy randomization. Patients must have recovered (≤ Grade 1) from any side effects of prior therapy, except for alopecia. Patients must not have received any radiation therapy within 14 days prior to sub-study randomization.
- Patients must not have received nitrosoureas or mitomycin-c within 42 days prior to sub-study randomization.
- Patients must not have received systemic treatment with corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within seven days prior to sub-study randomization. Inhaled or topical steroids, and
adrenal replacement doses ≤ 10 mg daily prednisone or equivalent are permitted in the absence of active autoimmune disease.
- Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study. Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable.
- tients must have Zubrod performance status 0-1.