Back to results

Lung Cancer With Copanlisib and Durvalumab (LCD)

Primary Purpose

Non Small Cell Lung Cancer

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Durvalumab

Copanlisib

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Stage 3A, 3B, Chemoradiation therapy, Durvalumab consolidation/maintenance, Copanlisib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Markey Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Copanlisib (30-60mg iv)

Arm Description

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).

Outcomes

Primary Outcome Measures

Dose Limiting Toxicity

The number of dose limiting toxicities will be counted for each cohort.

Secondary Outcome Measures

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).

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.

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.

Full Information

NCT ID

NCT04895579

First Posted

May 17, 2021

Last Updated

February 24, 2023

Sponsor

Zhonglin Hao

Collaborators

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT04895579

Brief Title

Lung Cancer With Copanlisib and Durvalumab

Acronym

LCD

Official Title

Boosting Immune Response With Copanlisib in Locally Advanced Unresectable Non-Small Cell Lung Cancer Receiving Durvalumab, A Phase Ib Study

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 12, 2021 (Actual)

Primary Completion Date

June 2031 (Anticipated)

Study Completion Date

June 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Zhonglin Hao

Collaborators

Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Small Cell Lung Cancer

Keywords

Stage 3A, 3B, Chemoradiation therapy, Durvalumab consolidation/maintenance, Copanlisib

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Model Description

Dose finding cohort and dose expansion cohort up to 18 patients

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Copanlisib (30-60mg iv)

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Durvalumab

Other Intervention Name(s)

Imfinzi

Intervention Description

Durvalumab will be delivered at 10mg/kg via IV infusion at days 1 and 15 every 28 days or 1500 mg on D1, q4w.

Intervention Type

Drug

Intervention Name(s)

Copanlisib

Other Intervention Name(s)

Aliqopa

Intervention Description

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

Primary Outcome Measure Information:

Title

Dose Limiting Toxicity

Description

The number of dose limiting toxicities will be counted for each cohort.

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Objective Response Rate

Description

The objective response rate is evaluated by iRECIST 1.1, which includes all patients with partial response (iPR) or complete response (iCR).

Time Frame

approximately 10 years

Title

Progression-Free Survival

Description

Time Frame

approximately 10 years

Title

Duration of Response

Description

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.

Time Frame

approximately 10 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yvonne Taul, RN

Phone

859-323-2354

Yvonne.Taul@uky.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhonglin Hao, MD

Organizational Affiliation

University of Kentucky

Official's Role

Principal Investigator

Facility Information:

Facility Name

Markey Cancer Center

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhonglin Hao, MD

Phone

859-218-6704

zhonglin.hao@uky.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Lung Cancer With Copanlisib and Durvalumab

We'll reach out to this number within 24 hrs