Lung Cancer With Copanlisib and Durvalumab

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Zhonglin Hao
Study ID
NCT04895579
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
May 12, 2021
Status verified
Nov 2025
Primary completion
Nov 12, 2025
Completion
Nov 12, 2025

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Copanlisib (30-60mg iv)
    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).

Primary Outcome Measure

Dose Limiting Toxicity [ Time Frame: 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Markey Cancer CenterLexingtonKentucky40536-

Find similar trials in Lexington, KY

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Markey Cancer Center· Lexington, KY

Related Studies