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

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 H

Trial Details

NCT ID
NCT04499053
Phase
PHASE2
Sponsor
Georgetown University
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Durvalumab
  • Tremelimumab
Locations (sample)
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637
  • Baltimore, Maryland, United States|39.29038,-76.61219
  • Baltimore, Maryland, United States|39.29038,-76.61219

Key Eligibility Criteria

  • Patients with stage IV NSCLC who had undergone no previous systemic therapy for stage IV disease.
  • Patients with HIV must be on an effective combination anti-retroviral therapy (cART) regimen for ≥ 4 weeks. Also, patients need to meet the followi…
  • Documented HIV viral load \< 400 copies/mL
  • No AIDS-defining opportunistic infections within the last 12 months

For full eligibility, visit ClinicalTrials.gov.

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