Lung Cancer With Copanlisib and Durvalumab

Completed · Phase 1

Conditions studied: Non Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT04895579

Run by

Zhonglin Hao

People needed

11

Starts

2021-05-12

Expected to finish

2025-11-12

Last updated by the study team

2025-11-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Markey Cancer Center — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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