Lung Cancer With Copanlisib and Durvalumab

NCT04895579 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: MCC-20-LUN-119-PMC
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Dose Limiting Toxicity

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

  28 days

Secondary Outcomes (3)

• Objective Response Rate

  approximately 10 years

• Progression-Free Survival

  approximately 10 years

• Duration of Response

  approximately 10 years

Study Arms (1)

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).

Drug: Durvalumab; Drug: Copanlisib

Interventions

Durvalumab DRUG

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

Also known as: Imfinzi

Copanlisib (30-60mg iv)

Copanlisib DRUG

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

Also known as: Aliqopa

Copanlisib (30-60mg iv)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhonglin Hao: lead
• Bayer: collaborator

Study Sites (1)

Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

durvalumab; copanlisib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Zhonglin Hao, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Dose finding cohort and dose expansion cohort up to 18 patients

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 20, 2021
• Study Start: May 12, 2021
• Primary Completion: November 12, 2025
• Study Completion: November 12, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)