Lung Cancer With Copanlisib and Durvalumab
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Nov 18, 2025 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Zhonglin Hao
- Interventions being studied
- Drug: Durvalumab; Drug: Copanlisib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.
- 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Markey Cancer CenterLexington, Kentucky
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 18, 2025. Always confirm current availability with the study team.