Protocol: Lung Map Sub Study – SWOG-S1800D
Please Note: Below is brief eligibility, for full eligibility requirements, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!
- Participants must have been assigned to S1800D by the SWOG Statistics and Data Management Center (SDMC). Assignment to S1800D is determined by the
LUNGMAP or S1400 protocol.
- Participants must have measurable or non-measurable disease documented by CT or MRI.
- Participants must have a CT or MRI scan of the brain to evaluate for CNS disease within 42 days prior to sub-study randomization.
- Participants with spinal cord compression or brain metastases must have received local treatment to these metastases and remained clinically controlled and
asymptomatic for at least 7 days following stereotactic radiation and/or 14 days following whole brain radiation, and prior to sub-study randomization.
- Participants must not have any history of organ transplant that requires use of immunosuppressives.
- Participants must not have an active or uncontrolled infection in the opinion of the treating investigator.
- Participants must not have a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of
the investigational regimen.
- Participants must have progressed (in the opinion of the treating investigator) following the most recent line of therapy for NSCLC.
- Participants with a known sensitizing mutation for which an FDA-approved targeted therapy for NSCLC exists (e.g. EGFR, ALK gene fusions, ROS1, BRAF,
RET, NTRK, and MET sensitizing mutations), must have previously received at least one of the approved therapy(s).
- Participants must have received exactly one line of anti-PD-1 or anti-PD-L1 therapy for advanced disease given alone or in combination with platinum-based
chemotherapy. Participants must have experienced disease progression during or after this regimen.
- Participants must not have received anti-CTLA4 therapy (e.g. ipilimumab, tremelimumab), or other immune-modulatory therapy (e.g. anti-TIM-3, anti-LAG-3,
anti-GITR, IL-2, IL-15).
- Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to substudy randomization.
- Participants must not have received any radiation therapy within 14 days prior to sub-study randomization.
- Participants must not have received nitrosoureas or mitomycin-c within 42 days prior to sub-study randomization.
- Participants must not have received systemic treatment with corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications
within 7 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.
- Participants must not have received a live attenuated vaccination within 28 days prior to sub-study randomization.
- Participants must not have had a major surgery within 14 days prior to sub-study randomization. Participant must have fully recovered from the effects of prior
surgery in the opinion of the treating investigator.
- Zubrod performance status must be 0-1.