Adebrelimab or Retlirafusp Alfa Plus Recaticimab and Chemotherapy for Resectable NSCLC

Sponsor
Peking University Cancer Hospital & Institute
Study ID
NCT07567326
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Adebrelimab, Retlirafusp alfa, Recaticimab and chemotherapy — DRUG
    Adebrelimab/Retlirafusp alfa IV +Recaticimab SC + platinum-based chemotherapy IV, 21-day cycle

Study Details

Although phase III studies have confirmed the efficacy and safety of perioperative immunotherapy plus chemotherapy for resectable NSCLC, there remains room for improvement in both short-term efficacy and long-term survival. Preclinical evidence suggests that PCSK-9 inhibition may synergize with PD-1 inhibitors to suppress tumor growth in mouse models. To date, no data are available on neoadjuvant PCSK-9 inhibitor therapy combined with immunotherapy and chemotherapy in resectable NSCLC. Therefore, this phase II study aims to evaluate the efficacy and safety of neoadjuvant adebrelimab or retlirafusp alfa (SHR-1701) plus recaticimab and chemotherapy in patients with resectable NSCLC.

Key Dates

First listed
May 5, 2026
Start date
Jul 31, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Adebrelimab plus recaticimab and chemotherapy
  • Experimental: Arm B
    Retlirafusp alfa plus recaticimab and chemotherapy

Primary Outcome Measure

pCR rate [ Time Frame: four weeks after surgery ]

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