Copanlisib + Durvalumab for Lung Cancer (LCD Trial)

Palo Alto (17 mi)

Overseen byZhonglin 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.

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 can take care of myself but might not be able to do heavy physical work.

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.

My lung cancer has both non-small and small cell types with known EGFR or ALK mutations.

My heart condition severely limits my physical activity.

I am not taking any medications that the study does not allow.

I take more than 10 mg of prednisone daily for a condition other than my cancer.

I have received a solid organ or bone marrow transplant.

I have a lung condition or severe breathing problems.

I have unstable chest pain.

Treatment Details

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.

1Treatment groups

Experimental Treatment

Group I: Copanlisib (30-60mg iv)Experimental Treatment2 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 European Union, United States, Japan for the following indications:

🇪🇺 Approved in European Union as Imfinzi for: