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

NCT ID: NCT07241819

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2028-11-30

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm1 PD-L1 TPS≥50%

Group Type: EXPERIMENTAL

Ivonescimab/surgery

Intervention Type: COMBINATION_PRODUCT

Ivonescimab monotherapy (4 cycles)→surgery→Ivonescimab(13 cycles)

Arm2 PD-L1 TPS≥50%

Group Type: ACTIVE_COMPARATOR

Ivonescimab/chemotherapy/surgery

Intervention Type: COMBINATION_PRODUCT

Ivonescimab + platinum-based chemotherapy (4 cycles)→surgery→Ivonescimab(13 cycles)

Arm3 PD-L1 TPS<50%

Group Type: EXPERIMENTAL

Ivonescimab/chemotherapy/surgery

Intervention Type: COMBINATION_PRODUCT

Ivonescimab + 1cycle of platinum-based chemotherapy followed by 3 cycles of Ivonescimab monotherapy→surgery→Ivonescimab(13 cycles)

Arm4 PD-L1 TPS<50%

Group Type: ACTIVE_COMPARATOR

Ivonescimab/chemotherapy/surgery

Intervention Type: COMBINATION_PRODUCT

Ivonescimab + platinum-based chemotherapy (4 cycles)→surgery→Ivonescimab(13 cycles)

Interventions

Ivonescimab/surgery

Ivonescimab monotherapy (4 cycles)→surgery→Ivonescimab(13 cycles)

Intervention Type: COMBINATION_PRODUCT

Ivonescimab/chemotherapy/surgery

Ivonescimab + 1cycle of platinum-based chemotherapy followed by 3 cycles of Ivonescimab monotherapy→surgery→Ivonescimab(13 cycles)

Intervention Type: COMBINATION_PRODUCT

Ivonescimab/chemotherapy/surgery

Ivonescimab + platinum-based chemotherapy (4 cycles)→surgery→Ivonescimab(13 cycles)

Intervention Type: COMBINATION_PRODUCT

Ivonescimab/chemotherapy/surgery

Ivonescimab + platinum-based chemotherapy (4 cycles)→surgery→Ivonescimab(13 cycles)

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

1. Voluntarily sign a written informed consent form;

2. Aged ≥ 18 years and ≤ 75 years , both males and females are eligible;

3. ECOG PS score of 0 or 1;

4. Patients with non-small cell lung cancer confirmed by histopathology or cytology, and with resectable clinical stage II-IIIB (T3N2) (according to the 8th edition of lung cancer TNM staging by the Union for International Cancer Control and the American Joint Committee on Cancer);

5. No prior anti-tumor treatment has been received;

6. No known EGFR sensitive mutations/ALK gene translocations;

Exclusion Criteria

1. Patients with large cell carcinoma, mixed-cell lung cancer, or those with small cell lung cancer components in the mixture;

2. Presence of locally advanced unresectable or metastatic disease;

3. Palliative local treatment for non-target lesions within 2 weeks before the first administration; receipt of non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, tumor necrosis factor, etc., excluding IL-11 used for the treatment of thrombocytopenia) within 2 weeks before the first administration; receipt of Chinese herbal medicines or proprietary Chinese medicines with anti-tumor indications within 1 week before the first administration.

4. Severe infection occurred within 4 weeks before the first administration, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; active infection treated with systemic anti-infective therapy within 2 weeks before the first administration (excluding antiviral therapy for hepatitis B or hepatitis C);

5. Major surgical operation or severe trauma occurred within 4 weeks before the first administration, or those with a plan for major surgical operation within 4 weeks after the first administration (determined by the researcher); minor local surgery performed within 3 days before the first administration (excluding peripherally inserted central catheterization and venous access port implantation);

6. History of severe bleeding tendency or coagulation dysfunction; presence of clinically significant bleeding symptoms within 1 month before the first administration, including but not limited to gastrointestinal bleeding, hemoptysis (defined as coughing up or expectorating ≥ 1 teaspoon of fresh blood or small blood clots, or coughing up only blood without sputum; those with blood-tinged sputum are allowed to enroll), nasal bleeding (excluding epistaxis and retrograde epistaxis); receipt of continuous antiplatelet or anticoagulant therapy within 10 days before the first administration.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Wu Nan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Nan Wu

Role: CONTACT

nanwu@bjmu.edu.cn

+86139 1015 4426

Other Identifiers

2025YJZ75-ZY01

Identifier Type: -

Identifier Source: org_study_id