Comparison of Neoadjuvant Cadonilimab Versus Chemotherapy Combined With PD-1 in the Treatment of Resectable Non-Small Cell Lung Cancer With High PD-L1 Expression: A Single-Center, Randomized, Exploratory Clinical Study

NCT06946836 | Not Yet Recruiting Phase 2

• 1 other identifier: LungMate-027
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The advent of immunotherapy has changed the treatment landscape for patients with non-small cell lung cancer. It has become the mainstay of perioperative treatment for patients with resectable non-small cell lung cancer。 Cadonilimab is the world's first bispecific antibody drug targeting PD-1 and CTLA-4. Previous studies on AK104 have demonstrated preliminary efficacy in both treatment-naïve advanced NSCLC patients and immunotherapy-resistant patients, showing a favorable safety and tolerability profile. This study aims to evaluate the effectiveness of neoadjuvant bispecific antibody AK104 compared with neoadjuvant chemotherapy combined with a PD-1 inhibitor in the treatment of resectable non-small cell lung cancer (NSCLC) with high PD-L1 expression.

Conditions

Resectable Non-small Cell Lung Cancer; Bispecific Antibody; Neoadjuvant Therapy

Keywords

Resectable non-small cell lung cancer; bispecific antibody; Neoadjuvant therapy

Outcome Measures

Primary Outcomes (1)

• PCR

  a complete absence of viable tumor cells in the primary tumor site and surgically removed lymph nodes after neoadjuvant treatment

  up to 60 months

Secondary Outcomes (7)

• MPR

  up to 60 months

• ORR

  up to 60 months

• OS

  up to 60 months

• EFS

  up to 60 months

• Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0

  up to 60 months

Study Arms (1)

AK104 monotherapy PD-1 combined with chemotherapy

EXPERIMENTAL

Enrolled patients will receive 3 cycles of AK104 monotherapy as neoadjuvant treatment, administered every 21 days.

Drug: AK104

Interventions

AK104 DRUG

Eligible patients will be randomly assigned in a 1:1 ratio to either the PD-1 combined with chemotherapy group or the AK104 monotherapy group. Treatment will be administered every 3 weeks, with patients undergoing three preoperative treatment cycles before surgery.

Also known as: PD-1 combined with chemotherapy

AK104 monotherapy PD-1 combined with chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient shall sign the Informed Consent Form.
• Aged 18 ≥ years.
• Histological or cytological diagnosis of NSCLC by needle biopsy, and stage IB-IIIA confirmed by imageological examinations (CT, PET-CT or EBUS) and Treatment-naïve for relevant antitumor therapy .
• Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
• Life expectancy is at least 12 weeks.
• At least 1 measurable lesion according to RECIST 1.1.
• Patients with good function of other main organs (liver, kidney, blood system, etc.)
• Patients with lung function can tolerate surgery;
• Without systematic metastasis (including M1a, M1b and M1c);
• Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of serplulimab (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.
• Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of serplulimab (whichever is later).

You may not qualify if:

• Histology suggestive of small cell component and Participants who have received any systemic anti-cancer treatment for thymic epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment; 2. Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (\>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases; 3. With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment; 4. Participants who are allergic to the test drug or any auxiliary materials; 5. Participants with Interstitial lung disease currently; 6. Participants with active hepatitis B, hepatitis C or HIV; 7. Pregnant or lactating women; 8. Participants suffering from nervous system diseases or mental dieases that cannot cooperate; 9.Participated in another therapeutic clinical study; Other factors that researchers think it is not suitable for enrollment.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Peng Zhang Peng Zhang, PhD

CONTACT

02165115006; zhangpeng1121@tongji.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shanghai Pulmonary Hospital, Shanghai, China

Model Details: Eligible patients will be randomly assigned in a 1:1 ratio to either the immunotherapy-combined chemotherapy group or the AK104 monotherapy group. Treatment will be administered every 3 weeks, with patients undergoing three preoperative treatment cycles before surgery.

Study Record Dates

• First Submitted: April 19, 2025
• First Posted: April 27, 2025
• Study Start: April 21, 2025
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): May 11, 2031
• Last Updated: April 27, 2025

Record last verified: 2025-04