Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04499053 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv14
  2. Site contacts updated at 1 of 4 sitesv13
  3. Primary completion date: Dec 2025 to Feb 2027 Completion date: Dec 2025 to Dec 2027 · Site details revised at 1 of 4 sitesv12 Show 2 more changesShow less
    • Completion date: Dec 2025 to Dec 2027
    • Site details revised at 1 of 4 sites
  4. Primary and study completion dates: Dec 2024 to Dec 2025 Study sites: 3 to 4v11 Show 1 more changeShow less
    • Study sites: 3 to 4
  5. Eligibility criteria shortened, about 108 words Study description shortened, about 6 words · Site contacts updated at 1 of 3 sites · Study title revisedv10 Show 3 more changesShow less
    • Study description shortened, about 6 words
    • Site contacts updated at 1 of 3 sites
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

Show 8 earlier versionsHide 8 earlier versions
  1. Re-verified, no change to tracked fieldsv9
  2. Primary and study completion dates: Sep 2023 to Dec 2024v8
  3. Interventions: Durvalumab (Drug) to Durvalumab (Drug), Tremelimumab (Drug) Eligibility criteria expanded, about 95 words · Study description expanded, about 24 words · Study title expanded, about 2 wordsv7 Show 3 more changesShow less
    • Eligibility criteria expanded, about 95 words
    • Study description expanded, about 24 words
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Site contacts updated at 2 of 3 sitesv6
  5. Eligibility criteria expanded, about 8 words Secondary endpoints: 4 to 3 · Site details revised at 2 of 3 sitesv5 Show 2 more changesShow less
    • Secondary endpoints: 4 to 3
    • Site details revised at 2 of 3 sites

    See this version in full on ClinicalTrials.gov ↗

  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 3 · Start date changed from estimate of Nov 2020 to Dec 9, 2020v4 Show 2 more changesShow less
    • Study sites: 1 to 3
    • Start date changed from estimate of Nov 2020 to Dec 9, 2020
  7. Start date: Sep 2020 to Nov 2020v3
  8. Secondary endpoints revised (4)v2 See this version in full on ClinicalTrials.gov ↗
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04499053
Lead Sponsor Georgetown University
Collaborators: AstraZeneca
Conditions Carcinoma, Non-Small Cell Lung
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov