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Safety and Efficacy of NK510 to Treat NSCLC

StatusRecruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Jul 1, 2026 → Jul 1, 2027
See other at-risk trials from Base Therapeutics (Shanghai) Co., Ltd.

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv7
  2. Primary completion pushed from Jul 1, 2026 to Jul 1, 2027
    • Study completion pushed from Jul 1, 2026 to Jul 1, 2028
    v6
  3. Re-verified, no change to tracked fieldsv5
  4. Primary endpoints revised (2)v4 Show 7 more changesShow less
    • Enrollment target: 9 to 12
    • Interventions: NK510 (Drug), Tislelizumab，atezolizumab or sugemalimab (Drug) to NK510 (Drug), NK510 (Drug), Tislelizumab，atezolizumab or sugemalimab (Drug), systemic therapy as selected by the investigator (Drug)
    • Eligibility criteria shortened, about 224 words
    • Secondary endpoints: 1 to 6
    • Study site revised
    • Collaborator revised
    • Study arms: 3 to 5
  5. Primary and study completion dates: Jul 1, 2024 to Jul 1, 2026v3
  6. Interventions: NK510 (Drug), monoclonal anti-PD1 antibody (Drug) to NK510 (Drug), Tislelizumab，atezolizumab or sugemalimab (Drug)v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 assesses the safety and efficacy of NK510 combined with PD-(L)1 inhibitors for relapsed/refractory advanced NSCLC, with two administration routes: intravenous infusion and intrapleural perfusion for malignant pleural effusion. Eligible patients need confirmed measurable lesions; intravenous cohort requires EGFR/ROS1/ALK negativity and disease progression after PD-(L)1 inhibitor treatment, while intrapleural cohort accepts targeted therapy-resistant patients with ≥500ml pleural effusion, and the treatment's safety, efficacy and immune microenvironment changes will be evaluated.
Trial Details
NCT Number NCT06097962
Lead Sponsor Base Therapeutics (Shanghai) Co., Ltd.
Collaborators: Jinling Hospital, China
Conditions
(from sponsor)		 NSCLC
Related terms Pleural Effusion, Malignant
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov