Copanlisib + Durvalumab for Lung Cancer

(LCD Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Zhonglin Hao

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Zhonglin Hao

No Placebo Group

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Zhonglin Hao

Principal Investigator

University of Kentucky

Eligibility Criteria

This trial is for adults with stage III non-small cell lung cancer (NSCLC) that can't be removed by surgery. They should have received chemoradiation and are about to start Durvalumab therapy. Participants need at least one measurable lesion, good performance status, proper organ function, and must understand and sign consent forms. People with certain heart conditions, mixed lung cancers, specific gene mutations, or on prohibited medications cannot join.

Inclusion Criteria

My lung cancer is confirmed and cannot be removed by surgery, but I have had chemoradiation.

I will start Durvalumab as a follow-up treatment.

You have at least one spot that can be measured to see if the treatment is working.

Exclusion Criteria

I have not had any major surgeries in the last 28 days.

I have not had serious bleeding issues in the last month.

I have received chemotherapy and radiation therapy one after the other.

Treatment Details

Interventions

• Copanlisib (PI3K Inhibitor)
• Durvalumab (PD-L1 Inhibitor)

Trial Overview The study tests if adding Copanlisib to Durvalumab after chemoradiation improves outcomes in NSCLC patients aiming for a cure. It examines the safety of combining these drugs biweekly and whether this combination can help overcome resistance to Durvalumab alone.

Participant Groups

Group I: Copanlisib (30-60mg iv) Experimental Treatment 2 Interventions

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).

Durvalumab is already approved in Japan for the following indications:

Approved in Japan as Imfinzi for:

• Not specified in provided sources

Who Is Running the Clinical Trial?

Zhonglin Hao

Lead Sponsor

Trials

4

Recruited

50+

Bayer

Industry Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

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Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD