Lung Cancer With Copanlisib and Durvalumab

  • STATUS
    Recruiting
  • End date
    Jun 29, 2031
  • participants needed
    18
  • sponsor
    Zhonglin Hao
Updated on 29 May 2021
measurable disease
durvalumab
stage iii non-small cell lung cancer
lung carcinoma

Summary

The current study focuses on unresectable stage III non-small cell lung cancer (NSCLC) patients who have disease progression while on 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.

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). 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.

Details
Condition nsclc, Non-Small Cell Lung Cancer
Treatment durvalumab, Copanlisib
Clinical Study IdentifierNCT04895579
SponsorZhonglin Hao
Last Modified on29 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically confirmed NSCLC (e.g., adenocarcinoma, squamous cell) deemed unresectable or inoperable who have received concurrent chemoradiation followed by Durvalumab consolidation
Disease progression during or within 3 months of completion of Durvalumab treatment
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
Left ventricular ejection fraction less than 40%
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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