Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04499053

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

Led by Georgetown University · Updated on 2026-03-16

18

Participants Needed

4

Research Sites

364 weeks

Total Duration

On this page

Sponsors

G

Georgetown University

Lead Sponsor

A

AstraZeneca

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with stage IV NSCLC who have not received previous systemic therapy for stage IV disease
  • HIV-infected patients must be on effective combination anti-retroviral therapy for at least 4 weeks
  • Documented HIV viral load less than 400 copies/mL
  • No AIDS-defining opportunistic infections within the last 12 months
  • No concurrent incurable AIDS-defining malignancy
  • Age greater than 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Body weight greater than 30 kg
  • Adequate organ and marrow function defined by specific laboratory values including hemoglobin, neutrophil count, platelet count, CD4 T-cell count, bilirubin, liver enzymes, and creatinine clearance
  • Evidence of post-menopausal status or negative pregnancy test for pre-menopausal females with specific age-related criteria
  • Willingness and ability to comply with study protocol and visits
  • Life expectancy of at least 12 weeks
Not Eligible

You will not qualify if you...

  • Presence of sensitizing EGFR mutations or ALK translocations
  • Coinfection of HIV with HBV without appropriate antiviral therapy
  • Coinfection of HIV with HCV unless cured or on appropriate antiviral therapy
  • No measurable disease
  • Receipt of anticancer therapy within 21 days prior to study treatment
  • Unresolved grade 2 or higher toxicity from previous cancer therapy except alopecia or vitiligo
  • Whole brain radiation therapy within 2 weeks prior to treatment
  • Major surgery within 4 weeks prior to study drug or not recovered from surgery side effects
  • History of allogenic organ transplantation
  • Active or prior autoimmune or inflammatory disorders except specified exceptions
  • Uncontrolled intercurrent illness including active infection or significant cardiac or psychiatric conditions
  • Previously untreated CNS metastases or leptomeningeal disease
  • Active tuberculosis
  • Use of immunosuppressive medication within 7 days before durvalumab except specified exceptions
  • Receipt of live attenuated vaccine within 30 days prior to first dose
  • Pregnancy or breastfeeding or unwillingness to use effective birth control
  • Known allergy to study drugs or excipients
  • Prior anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy within 12 months
  • Investigator judgment of unsuitability or inability to comply with study requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Georgetown Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, United States, 20007

Actively Recruiting

2

Medstar Washington Hospital Center

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

3

Marlene and Stewart Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States, 21201

Actively Recruiting

4

Harry and Jeannette Weinberg Cancer Institute at Franklin Square

Baltimore, Maryland, United States, 21237

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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