Ivonescimab Monotherapy or in Combination With Chemotherapy as Neoadjuvant/Adjuvant Therapy for Resectable Non-small Cell Lung Cancer

Sponsor
Peking University Cancer Hospital & Institute
Study ID
NCT07241819
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • II-IIIB (T3N2) Resectable Non-small Cell Lung Cancer
  • Perioperative

Eligibility Criteria

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

Interventions

  • Ivonescimab/surgery — COMBINATION_PRODUCT
    Ivonescimab monotherapy (4 cycles)→surgery→Ivonescimab(13 cycles)
  • Ivonescimab/chemotherapy/surgery — COMBINATION_PRODUCT
    Ivonescimab + 1cycle of platinum-based chemotherapy followed by 3 cycles of Ivonescimab monotherapy→surgery→Ivonescimab(13 cycles)
  • Ivonescimab/chemotherapy/surgery — COMBINATION_PRODUCT
    Ivonescimab + platinum-based chemotherapy (4 cycles)→surgery→Ivonescimab(13 cycles)
  • Ivonescimab/chemotherapy/surgery — COMBINATION_PRODUCT
    Ivonescimab + platinum-based chemotherapy (4 cycles)→surgery→Ivonescimab(13 cycles)

Study Details

This study is a prospective, II Phase clinical trial designed to evaluate the efficacy and safety of ivonescimab as monotherapy or in combination with platinum-based chemotherapy in the perioperative treatment of resectable non-small cell lung cancer (NSCLC). Patients are stratified by PD-L1 expression level (TPS ≥50% vs. \<50%) and randomized in a 2:1 ratio to differentiated neoadjuvant treatment arms: PD-L1≥50% subgroup: Ivonescimab monotherapy (4 cycles) vs. ivonescimab + platinum-based chemotherapy (4 cycles); PD-L1\<50% subgroup: Ivonescimab + 1 cycle of chemotherapy followed by 3 cycles of monotherapy vs. ivonescimab + platinum-based chemotherapy (4 cycles). All patients subsequently receive 13 cycles of ivonescimab as adjuvant maintenance therapy postoperatively. As the first study to explore a PD-L1-directed chemotherapy de-escalation strategy, this trial aims to reduce treatment toxicity while maintaining efficacy, thereby providing a novel personalized precision therapy pathway for resectable NSCLC.

Key Dates

Start date
Nov 30, 2025
Status verified
Nov 2025
Primary completion
Nov 30, 2027
Completion
Nov 30, 2028

Study Design

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

Arms

  • Experimental: Arm1 PD-L1 TPS≥50%
  • Active Comparator: Arm2 PD-L1 TPS≥50%
  • Experimental: Arm3 PD-L1 TPS<50%
  • Active Comparator: Arm4 PD-L1 TPS<50%

Primary Outcome Measure

Pathological Complete Response（pCR）rate [ Time Frame: At the time of postoperative pathological assessment，Up to approximately 2 years ]

Central Contacts