New drug combo aims to overcome resistance in lung cancer treatment
NCT ID NCT04895579
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tested whether adding copanlisib to the standard immune therapy durvalumab is safe for people with stage III non-small cell lung cancer that cannot be removed by surgery. The study enrolled 11 participants who had already received chemotherapy and radiation. The main goal was to check for side effects and find the best dose, with a secondary look at how well the tumors responded.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Copanlisib (Aliqopa) and Durvalumab (Imfinzi)
- What this could lead to
- If this combination is safe and effective, it could offer a new option to improve outcomes for people with advanced lung cancer who are already on durvalumab.
- What could go wrong
- This is a very early phase 1 trial with only 11 participants, so results may not apply to everyone. The main goal is safety, not yet proof of benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
11 people
The number who actually took part.
- Started
-
May 2021
- Finished
-
Nov 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Markey Cancer Center
Lexington, Kentucky, 40536, United States
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Other studies related to the condition(s) this trial covers.
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