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Neoadjuvant and Adjuvant Therapy Studies of Sindilizumab in Resectable Lung Cancer

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 26, 2025 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 500 to confirmed 506 · Site details revisedv5 Show 2 more changesShow less
    • Enrollment target: estimated 500 to confirmed 506
    • Site details revised
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Mar 11, 2024 to Mar 15, 2024 · Site details revisedv4 Show 2 more changesShow less
    • Start date changed from estimate of Mar 11, 2024 to Mar 15, 2024
    • Site details revised
  3. Re-verified, no change to tracked fieldsv3
  4. Enrollment target: 800 to 500 Primary completion date: Aug 18, 2023 to Sep 30, 2026 · Start date: Nov 11, 2021 to Mar 11, 2024 · Primary endpoints revised (2) · 4 morev2 Show 7 more changesShow less
    • Primary completion date: Aug 18, 2023 to Sep 30, 2026
    • Start date: Nov 11, 2021 to Mar 11, 2024
    • Primary endpoints revised (2)
    • Completion date: Jun 20, 2026 to Oct 14, 2028
    • Interventions: Carboplatin (Drug), Cisplatin (Drug), Docetaxel (Drug), Gemcitabine (Drug), Nab-paclitaxel (Drug), Paclitaxel (Drug), Pemetrexed (Drug)… to Carboplatin (Drug), Cisplatin (Drug), Nab paclitaxel (Drug), Paclitaxel (Drug), Pemetrexed (Drug), Placebo (Drug), Sintilimab (Drug)
    • Eligibility criteria shortened, about 7 words
    • Secondary endpoints: 8 to 4

    See this version in full on ClinicalTrials.gov ↗

  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study is a randomized, double-blind Phase 3 study to compare the efficacy and safety of Sindilizumab combined with chemotherapy or placebo combined with chemotherapy for neoadjuvant and adjuvant therapy for Resectable Stage II to IIIB (resectable N2 only) non-small cell lung cancer (NSCLC).
Trial Details
NCT Number NCT05116462
Lead Sponsor Innovent Biologics (Suzhou) Co. Ltd.
Conditions Non-Small Cell Lung Cancer
Enrollment 506 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov