Adding Certolizumab to Chemotherapy + Nivolumab in People Who Have Lung Cancer That Can Be Treated With Surgery

StatusRecruiting
PhasePhase 2
Started

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Record History

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  1. Interventions modified
    • Eligibility criteria expanded, about 70 words
  2. Primary and study completion dates: Oct 2025 to Oct 2026v19
  3. Re-verified, no change to tracked fieldsv18
  4. Primary and study completion dates: Oct 2024 to Oct 2025
    • Site details revised at 1 of 7 sites
    v17
  5. Site details revised at 1 of 7 sitesv16
Show 14 earlier versionsHide 14 earlier versions
  1. 2 versions Re-verified since Jun 12, 2024, no change to tracked fieldsv14-v15
  2. Eligibility criteria expanded, about 491 wordsv13
  3. Eligibility criteria shortened, about 898 wordsv12
  4. Trial status: Not Yet Recruiting to Recruitingv11 Show 8 more changesShow less
    • Primary and study completion dates: Oct 2023 to Oct 2024
    • Primary endpoint revised
    • Start date changed from estimate of Sep 2022 to Oct 19, 2022
    • Interventions: Carboplatin (Drug), Certolizumab (Drug), Cisplatin (Drug), Gemcitabine (Drug), Pemetrexed (Drug) to Carboplatin (Drug), Certolizumab (Drug), Cisplatin (Drug), Gemcitabine (Drug), Nivolumab (Drug), Pemetrexed (Drug)
    • Eligibility criteria expanded, about 1,306 words
    • Site details revised at 7 of 7 sites
    • Study title revised
    • Study arms: 1 to 2
  5. Start date: Aug 2022 to Sep 2022v10
  6. Start date: Jul 2022 to Aug 2022v9
  7. Start date: Jun 2022 to Jul 2022v8
  8. Start date: Apr 2022 to Jun 2022v7
  9. Start date: Feb 2022 to Apr 2022v6
  10. Start date: Dec 2021 to Feb 2022v5
  11. Start date: Nov 2021 to Dec 2021v4
  12. Start date: Oct 2021 to Nov 2021v3
  13. Start date: Aug 2021 to Oct 2021
    • Primary and study completion dates: Aug 2023 to Oct 2023
    v2
  1. Study First Submitted
  • 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.
The purpose of the study is to explore adding the study drug certolizumab to standard chemotherapy as it may reduce the inflammation caused by the cancer and make the chemotherapy more effective in shrinking the cancer. This study will examine whether adding certolizumab to the usual treatment approach is better than, the same as, or worse than the usual approach alone.
Trial Details
NCT Number NCT04991025
Lead Sponsor Memorial Sloan Kettering Cancer Center
Conditions
(from sponsor)		 Lung Cancer, Lung Cancer Stage II, Lung Cancer Stage III
Related terms Lung Neoplasms
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov