NCT04895579CompletedPhase 1
Lung Cancer With Copanlisib and Durvalumab
Boosting Immune Response With Copanlisib in Locally Advanced Unresectable Non-Small Cell Lung Cancer Receiving Durvalumab, A Phase Ib Study
Source: ClinicalTrials.gov · Last updated 18 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 11 (actual)
- First submitted
- 17 May 2021
- Start date
- 12 May 2021
- Primary completion date
- 12 Nov 2025
- Lead sponsor
- Zhonglin Hao
- Diseases
- Lung cancer
- NCT number
- NCT04895579
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 11
- From 12 May 2021 to the primary completion date, 12 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Received live vaccine in the past 4 weeks.
- Receiving medications prohibited by the study.
Other illness
- 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.
- 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.
- Any illness or medical conditions that are unstable or could jeopardize the safety of patients and their compliance in the study.
Lab values
- Mixed Non-small cell and small cell histology; known EGFR and/or ALK driver mutations.
- Proteinuria of ≥ CTCAE Grade 3 or estimated by urine protein: creatinine ratio \> 3.5
Other
- Pregnant or breast-feeding/lactating women.
- Major surgeries within the last 28 days.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Markey Cancer Center Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.