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Lung Cancer With Copanlisib and Durvalumab (LCD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04895579
Recruitment Status : Recruiting
First Posted : May 20, 2021
Last Update Posted : March 9, 2022
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Zhonglin Hao, University of Kentucky

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 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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: Durvalumab Drug: Copanlisib Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Dose finding cohort and dose expansion cohort up to 18 patients
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Boosting Immune Response With Copanlisib in Locally Advanced Unresectable Non-Small Cell Lung Cancer Receiving Durvalumab, A Phase Ib Study
Actual Study Start Date : May 12, 2021
Estimated Primary Completion Date : June 2031
Estimated Study Completion Date : June 2031

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Copanlisib (30-60mg iv)
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).
Drug: Durvalumab
Durvalumab will be delivered at 10mg/kg via IV infusion at days 1 and 15 every 28 days or 1500 mg on D1, q4w.
Other Name: Imfinzi

Drug: Copanlisib
Copanlisib will be delivered at various doses (30-60mg/kg) via IV infusion at days 1 and 15 every 28 days.
Other Name: Aliqopa




Primary Outcome Measures :
  1. Dose Limiting Toxicity [ Time Frame: 28 days ]
    The number of dose limiting toxicities will be counted for each cohort.


Secondary Outcome Measures :
  1. Objective Response Rate [ Time Frame: approximately 10 years ]
    The objective response rate is evaluated by iRECIST 1.1, which includes all patients with partial response (iPR) or complete response (iCR).

  2. Progression-Free Survival [ Time Frame: approximately 10 years ]
    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.

  3. Duration of Response [ Time Frame: approximately 10 years ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04895579


Contacts
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Contact: Yvonne Taul, RN 859-323-2354 Yvonne.Taul@uky.edu

Locations
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United States, Kentucky
Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Zhonglin Hao, MD    859-218-6704    zhonglin.hao@uky.edu   
Sponsors and Collaborators
Zhonglin Hao
Bayer
Investigators
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Principal Investigator: Zhonglin Hao, MD University of Kentucky
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Responsible Party: Zhonglin Hao, Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT04895579    
Other Study ID Numbers: MCC-20-LUN-119-PMC
First Posted: May 20, 2021    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhonglin Hao, University of Kentucky:
Stage 3A, 3B
Chemoradiation therapy
Durvalumab consolidation/maintenance
Copanlisib
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Durvalumab
Antineoplastic Agents, Immunological
Antineoplastic Agents