Alliance A082002

Clinical Trial Title Randomized Phase II/III Trial of Modern Immunotherapy Based Systemic Therapy with or without Radiation Therapy for PD-L1-Negative, Advanced Non-small Cell Lung Cancer
Trial Status Open to Enrollment
Start Date 06/02/2025
Location All Hospitals
Trial Type Cancer - Adult Oncology
Specific Condition Lung Cancer
Description This phase II/III trial compares the addition of radiation therapy to the usual treatment (immunotherapy with or without chemotherapy) versus (vs.) usual treatment alone in treating patients with non-small cell lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic) whose tumor is also negative for a molecular marker called PD-L1. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The addition of radiation therapy to usual treatment may stop the cancer from growing and increase the life of patients with advanced non-small cell lung cancer who are PD-L1 negative.
Eligibility Criteria

Eligibility Criteria

  • Histologic or cytologic diagnosis of Stage IV NSCLC using version AJCC 8th edition (includes M1a, M1b, and M1c stage disease). Patients with Stage IIIB and IIIC disease are eligible if they are not a candidate for combined chemotherapy and radiation.
  • PD-L1 IHC: PD-L1 expression Tumor Proportion Score (TPS) <1% in tumor cells. If PD-L1 expression TPS is unevaluable or the testing could not be completed patients are not eligible. The assay must have been performed locally by a CLIA (or equivalent) certified laboratory. The type of assay will be recorded.
  • For non-squamous patients only (adenocarcinoma or adenosquamous): EGFR, ALK and ROS1 testing must be done locally. No patients with known actionable EGFR mutations (except exon 20 insertion), ALK or ROS1 mutations that can be treated with oral tyrosine inhibitors.
  • Measurable disease based on RECIST 1.1, including at least two cancerous deposits. At least one deposit must be RECIST measurable (and not to be irradiated) while at least one OTHER deposit (measurable or non-measurable) must meet criteria for three 8 Gy doses of radiation
  • Prior Treatment
  • No more than three weeks of treatment with systemic chemotherapy or immunotherapy for advanced NSCLC.
  • No more than three weeks of treatment with checkpoint inhibitors for metastatic lung cancer.
  • No treatment with chemotherapy or immunotherapy for non-metastatic disease (e.g., adjuvant therapy) within 6 months prior to registration.
  • Required Initial Laboratory Values:
  • Absolute Neutrophil Count (ANC) ≥ 1,500/mm3
  • Platelet Count ≥ 100,000/mm3
  • Calc. Creatinine Clearance ≥ 45 mL/min
  • Total Bilirubin ≤ 1.5 x upper limit of normal (ULN)
  • AST / ALT ≤ 2.5 x upper limit of normal (ULN)

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.
IRB Number Central IRB
Notes Study Details | Testing the Addition of Radiation Therapy to the Usual Treatment (Immunotherapy With or Without Chemotherapy) for Advanced Stage Non-small Cell Lung Cancer Patients Who Are PD-L1 Negative | ClinicalTrials.gov
Principal Investigator Mei Dong, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail oncologyresearch@lhs.org