NCT04499053

Durvalumab and Tremelimumab in Combination With Chemotherapy in HIV-infected Patients With Non-small Cell Lung Cancer

A Phase II Trial of Durvalumab (MEDI4736) and Tremelimumab in Combination With Chemotherapy in HIV-infected Patients With Non-small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II trial of durvalumab and tremelimumab in combination of platinum-based chemotherapy. Patients with stage IV Non-Small-Cell-Lung Cancer (NSCLC) with human immunodeficiency virus (HIV) infection will be eligible. Patients will receive standard platinum-based chemotherapy plus durvalumab for 4 cycles (every 3 weeks), followed by durvalumab (with or without pemetrexed for non-squamous NSCLC) maintenance therapy. It is hypothesized that Durvalumab and tremelimumab in combination with standard chemotherapy is safe and effective for the treatment of stage IV NSCLC in patients with HIV infection.

Detailed description

This is an open-label, non-randomized phase II trial of durvalumab and tremelimumab in combination with platinum-based doublet chemotherapy. Patients with stage IV NSCLC with HIV infection will be eligible. Patients will receive standard chemotherapy plus durvalumab (1500 mg) and tremelimumab (75 mg) every three weeks for 4 cycles, followed by maintenance treatment with durvalumab (1500 mg Q4W; with or without pemetrexed for non-squamous NSCLC per the discretion of the investigator). A dose of tremelimumab 75 mg will be given at week 16. Patient will be enrolled into the trial using an optimal two-stage phase II trial design. If 0 of the 7 achieved a response, no further patients will be enrolled in that cohort. If 1 or more of the first 7 patients has a response, accrual would continue until a total of 18 patients have been enrolled in that cohort. Objective response will be evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Safety and tolerability will be evaluated by assessing the incidence of treatment-related grade 3 or higher AEs. Treatment-related grade 3 or higher AEs will be defined as any grade 3 or higher AEs that occur during the first 42 days of treatment and are related to the study treatment. AEs will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Subjects will receive 4 cycles of combination treatment: durvalumab (1500 mg every 3 weeks) and tremelimumab (75 mg every 3 weeks) in combination with platinum-based doublet chemotherapy. The platinum-based doublet chemotherapies (carboplatin plus paclitaxel/nab-paclitaxel vs. pemetrexed plus carboplatin/cisplatin) are dependent on the tumor histology of the subject (squamous vs. non-squamous). Only subjects who achieve stable disease or better radiological response after 4 cycles of induction treatment will be eligible to continue study treatment in maintenance. The choice to treat non-squamous subjects with pemetrexed maintenance after the 4 induction cycles will be determined by the investigator.

Conditions

• Carcinoma, Non-Small Cell Lung

Interventions

Type	Name	Description
DRUG	Durvalumab	durvalumab 1500 mg, intravenous, every 3 weeks for 4 cycles, followed by 1500 mg, intravenous, every 4 weeks (maintenance treatment)
DRUG	Tremelimumab	tremelimumab 75 mg, intravenous, every 3 weeks for 4 cycles. A dose of tremelimumab 75 mg will be given at week 16.

Timeline

• Start date: 2020-12-09
• Primary completion: 2027-02-01
• Completion: 2027-12-01
• First posted: 2020-08-05
• Last updated: 2026-03-16

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study