A Phase II Randomized Trial of Neoadjuvant Ivonescimab or Penpulimab Plus Chemotherapy in Resectable NSCLC

Sponsor
Yang Fan, MD
Study ID
NCT07086326
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • AK112
  • Bispecific Antibody
  • Immunotherapy
  • NSCLC
  • Neoadjuvant Therapy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ivonescimab+Chemo — DRUG
    Ivonescimab (AK112) + platinum-based doublet chemotherapy
  • Penpulimab+Chemo — DRUG
    Penpulimab (AK105) + platinum-based doublet chemotherapy

Study Details

This is a randomized, open-label, multicenter phase II study. The trial plans to enroll 164 subjects with resectable stage IIA-IIIB (N2) NSCLC. Participants will be randomized 1:1 into either the ivonescimab plus chemotherapy or penpulimab plus chemotherapy treatment arm. After 3-4 cycles of neoadjuvant therapy, surgical resection will be performed. The primary objective is to compare the pathological complete response (pCR) rate assessed by local pathologists between ivonescimab-based and penpulimab-based chemo-immunotherapy regimens in the neoadjuvant treatment of resectable NSCLC.

Key Dates

Start date
Jul 31, 2025
Status verified
Jul 2025
Primary completion
Dec 30, 2026
Completion
Dec 30, 2027

Study Design

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

Arms

  • Experimental: Ivonescimab+Chemo
    Ivonescimab (AK112) + platinum-based doublet chemotherapy as neoadjuvant treatment, administered every 3 weeks (Q3W) for 3-4 cycles. Surgical resection should be performed 4-6 weeks after the last dose, followed by safety follow-up and survival surveillance.
  • Active Comparator: Penpulimab+Chemo
    Penpulimab (AK105) + platinum-based doublet chemotherapy as neoadjuvant treatment, administered every 3 weeks (Q3W) for 3-4 cycles. Surgical resection should be performed 4-6 weeks after the last dose, followed by safety follow-up and survival surveillance.

Primary Outcome Measure

Pathologic Complete Response (pCR) Rate [ Time Frame: Within 1 month after surgery ]

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