Lung Cancer With Copanlisib and Durvalumab

• Status: Recruiting
• Trial end date: 2031-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The current study focuses on unresectable stage III non-small cell lung cancer (NSCLC) patients who have disease progression while on 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhonglin Hao
• Collaborator: Bayer
• Treatments: Durvalumab

Criteria

Inclusion Criteria:

• Histologically confirmed NSCLC (e.g., adenocarcinoma, squamous cell) deemed unresectable or inoperable who have received concurrent chemoradiation followed by Durvalumab consolidation.

• Disease progression during or within 3 months of completion of Durvalumab treatment.

• 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.

• Left ventricular ejection fraction less than 40%.

• 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.