Non Small Cell Lung CancerPhase 1LCDNCT04895579
Lung Cancer With Copanlisib and Durvalumab
A Phase 1 study testing Durvalumab and Copanlisib in people with Non Small Cell Lung Cancer, run by Zhonglin Hao at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Durvalumab and Copanlisib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2021to 12 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Boosting Immune Response With Copanlisib in Locally Advanced Unresectable Non-Small Cell Lung Cancer Receiving Durvalumab, A Phase Ib Study
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.
Read the 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 1500mg on D1 every 28 days. Copanlisib will be given as infusion intravenously on D1, D15 in a 28-day cycle (flat dose). The starting dose of Copalisib will be 60 mg D1 and D15. It will be reduced to 45 mg for the first dose reduction and to 30 mg for the second dose reduction. The Durvalumab dose will remain constant when Copanlisib is reduced.
Once the appropriate dose is determined, e.g. Copanlisib 60 mg iv d1, 15, q4w, in the dose-finding phase, this will become the recommended dose for the dose-expansion phase. Patients will be treated at the dose-expansion phase to increase our understanding of pharmacokinetics and to confirm safety as well as initial efficacy in this population.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Durvalumab, Copanlisib
- Keywords
- Stage 3A, 3B, Chemoradiation therapy, Durvalumab consolidation/maintenance, Copanlisib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Also called Imfinzi
Durvalumab will be delivered at 10mg/kg via IV infusion at days 1 and 15 every 28 days or 1500 mg on D1, q4w.
CopanlisibDrug
Also called Aliqopa
Copanlisib will be delivered at various doses (30-60mg/kg) via IV infusion at days 1 and 15 every 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Copanlisib (30-60mg iv) | Experimental | Patients in the group will receive Durvalumab at 10mg/kg (IV infusion on days 1 and 15, q28 days or 1500mg day 1 q28d). They will also receive Copanlisib ranging from 30mg to 60mg (IV infusion on days 1 and 15, q 28 days). Receives: Drug: Durvalumab; Drug: Copanlisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity
The number of dose limiting toxicities will be counted for each cohort.
Measured: 28 days
Secondary outcomes (3)
Objective Response Rate
The objective response rate is evaluated by iRECIST 1.1, which includes all patients with partial response (iPR) or complete response (iCR).
Measured: approximately 10 years
Progression-Free Survival
Progression-free survival (PFS) is defined as the time interval between the date patients are started on Copanlisib treatment to the date of disease progression, death or last follow-up, whichever occurs first. Patients who are intolerant to treatment and removed from study by the principal investigator or withdraw from the study will be treated as censored data for the PFS analysis.
Measured: approximately 10 years
Duration of Response
Duration of response (DOR) is defined as the time interval between the initial response to therapy and subsequent disease progression or relapse. Non-responders will be assigned a DOR equal to zero.
Measured: approximately 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start12 May 2021
- Primary completion12 Nov 2025
- Study completion12 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Dose finding cohort and dose expansion cohort up to 18 patients
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhonglin Hao
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor-investigator, Zhonglin Hao, University of Kentucky
- Investigators
- Zhonglin Hao, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895579
- Sponsor's protocol ID
- MCC-20-LUN-119-PMC
- Acronym
- LCD
- Status last verified
- Nov 2025
- First submitted
- 17 May 2021
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boosting Immune Response With Copanlisib in Locally Advanced Unresectable Non-Small Cell Lung Cancer Receiving Durvalumab, A Phase Ib Study
- ClinicalTrials.gov ID
- NCT04895579
- Acronym / sponsor ID
- LCD / MCC-20-LUN-119-PMC
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Stage 3A, 3B, Chemoradiation therapy, Durvalumab consolidation/maintenance, Copanlisib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Zhonglin HaoUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 12 May 2021 (actual)
- Primary completion
- 12 Nov 2025 (actual)
- Study completion
- 12 Nov 2025 (actual)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 1500mg on D1 every 28 days. Copanlisib will be given as infusion intravenously on D1, D15 in a 28-day cycle (flat dose). The starting dose of Copalisib will be 60 mg D1 and D15. It will be reduced to 45 mg for the first dose reduction and to 30 mg for the second dose reduction. The Durvalumab dose will remain constant when Copanlisib is reduced.
Once the appropriate dose is determined, e.g. Copanlisib 60 mg iv d1, 15, q4w, in the dose-finding phase, this will become the recommended dose for the dose-expansion phase. Patients will be treated at the dose-expansion phase to increase our understanding of pharmacokinetics and to confirm safety as well as initial efficacy in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose finding cohort and dose expansion cohort up to 18 patients
| Arm | Type | Receives |
|---|---|---|
| Copanlisib (30-60mg iv) | Experimental | Drug: Durvalumab, Drug: CopanlisibPatients in the group will receive Durvalumab at 10mg/kg (IV infusion on days 1 and 15, q28 days or 1500mg day 1 q28d). They will also receive Copanlisib ranging from 30mg to 60mg (IV infusion on days 1 and 15, q 28 days). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DurvalumabAlso: ImfinziDurvalumab will be delivered at 10mg/kg via IV infusion at days 1 and 15 every 28 days or 1500 mg on D1, q4w. | Drug | Copanlisib (30-60mg iv) |
| CopanlisibAlso: AliqopaCopanlisib will be delivered at various doses (30-60mg/kg) via IV infusion at days 1 and 15 every 28 days. | Drug | Copanlisib (30-60mg iv) |
Primary outcome
Dose Limiting Toxicity
Time frame: 28 days
The number of dose limiting toxicities will be counted for each cohort.
3 secondary outcomes
Objective Response Rate
Time frame: approximately 10 years
Progression-Free Survival
Time frame: approximately 10 years
Duration of Response
Time frame: approximately 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhonglin Hao, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Durvalumab and Copanlisib in people with Non Small Cell Lung Cancer, run by Zhonglin Hao at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.