Status:
COMPLETED
Lung Cancer With Copanlisib and Durvalumab
Lead Sponsor:
Zhonglin Hao
Collaborating Sponsors:
Bayer
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 overa...
Detailed Description
Treatment will be administered in outpatient settings. Durvalumab will be administered as infusion intravenously once every two weeks on D1 and D15, every 28 days (10 mg/Kg based on body weight) or 15...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2025
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04895579
Start Date
May 12 2021
End Date
November 12 2025
Last Update
November 18 2025
Active Locations (1)
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1
Markey Cancer Center
Lexington, Kentucky, United States, 40536