Boosting Immune Response With Copanlisib in Locally Advanced Unresectable Non-Small Cell Lung Cancer Receiving Durvalumab, A Phase Ib Study

MCC-20-LUN-119-PMC

The current study focuses on unresectable stage III non-small cell lung cancer (NSCLC) patients who are starting Durvalumab consolidation after concurrent chemoradiation with a goal of cure. The overall hypothesis of this study is that the addition of Copanlisib to Durvalumab will be well-tolerated at a biweekly schedule. It will test whether the addition of Copanlisib to Durvalumab can overcome resistance to Durvalumab.

2021-05-12

2025-06-01

2025-06-01

Active (not recruiting)

Early phase I

11

Inclusion Criteria: * Histologically confirmed NSCLC (e.g., adenocarcinoma, squamous cell) deemed unresectable or inoperable who have received concurrent chemoradiation. * Durvalumab will be started as consolidation therapy * Have at least one measurable lesion. * ECOG performance status ≤2. * Adequate organ and marrow function. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Mixed Non-small cell and small cell histology; known EGFR and/or ALK driver mutations. * Treated with sequential chemoradiation therapy. * Autoimmune disease, such as rheumatoid arthritis, systemic lupus erythematosus, requiring systemic treatment with immunosuppressant in the past two years. * Patients who are receiving any other investigational agents orally or intravenously. * Systemic steroid for other purpose exceeding 10 mg prednisone a day except local injection at the discretion of the investigator. * Solid organ or bone marrow transplant recipients. * History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function. * Patients with uncontrolled inter-current illness. * Patients with psychiatric illness/social situations that would limit compliance with study requirements and patients with seizure disorder not well controlled. * Received live vaccine in the past 4 weeks. * Pregnant or breast-feeding/lactating women. * Receiving medications prohibited by the study. * New York Heart Association Class 3 or above. * Myocardial infarction within the last 6 months. * Unstable angina. * Venous thromboembolism within last 3 months. * Evidence or history of bleeding diathesis. Any hemorrhage or bleeding event ≥ CTCAE Grade 3 within 4 weeks. * Proteinuria of ≥ CTCAE Grade 3 or estimated by urine protein: creatinine ratio \> 3.5 * Major surgeries within the last 28 days. * Any illness or medical conditions that are unstable or could jeopardize the safety of patients and their compliance in the study.

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2024-02-13