Local Consolidative Therapy (LCT) and Durvalumab (MEDI4736) for Oligoprogressive and Polyprogressive Stage III NSCLC After Chemoradiation and Anti-PD-L1 Therapy (ENDURE)
M.D. Anderson Cancer Center
Summary
This phase II trial finds out the effect of local consolidative therapy and durvalumab in treating patients with stage III non-small cell lung cancer that has 3 or fewer lesions of progression (oligoprogressive) and greater than 3 lesions of progression (polyprogressive) after chemoradiation and anti-PD-l1 therapy. Local consolidative therapy, such as surgery and/or radiation, after initial treatment may kill any remaining tumor cells. Immunotherapy with durvalumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving local consolidative therapy and durvalumab may help to control the disease.
Description
PRIMARY OBJECTIVES: I. To determine the efficacy of local consolidative therapy (LCT) followed by durvalumab for oligoprogressive non-small cell lung cancer (NSCLC) compared to historical standard control in terms of progression-free survival (PFS). II. To determine the efficacy of LCT followed by chemotherapy and durvalumab for polyprogressive NSCLC compared to historical standard control in terms of PFS. SECONDARY OBJECTIVES: I. To determine the efficacy of LCT followed by durvalumab for oligoprogressive NSCLC compared to historical standard control in terms of overall survival (OS)1. I…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol * Stage III NSCLC (AJCC 7th and 8th edition) patients who received standard chemoradiation followed by durvalumab therapy with either progressive disease or persistent disease. Persistent disease defined as residual positron emission tomography (PET) avidity 6 months after completion of initial definitive therapy and confirmed with biopsy * For lung adenocarcinoma patients, patients must not harbor any E…
Interventions
- DrugCarboplatin
Given IV
- BiologicalDurvalumab
Given IV
- DrugGemcitabine
Given IV
- ProcedureLocal Consolidation Therapy
Undergo LCT
- DrugNab-paclitaxel
Given IV
- DrugPaclitaxel
Given IV
- DrugPemetrexed
Given IV
Location
- M D Anderson Cancer CenterHouston, Texas