Trial Details

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

NCT04895579

ACTIVE_NOT_RECRUITING

DESCRIPTION

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.

CONDITIONS

ELIGIBILITY CRITERIA

• 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.