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

Launched by SHANGHAI PULMONARY HOSPITAL, SHANGHAI, CHINA · Apr 19, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at two different treatment options for patients with a type of lung cancer called non-small cell lung cancer (NSCLC) that can be surgically removed. Researchers want to compare a new drug called Cadonilimab, which is a special type of treatment known as a bispecific antibody, to standard chemotherapy combined with another drug that helps the immune system called a PD-1 inhibitor. The goal is to see which treatment works better before surgery in patients whose cancer has a high level of a specific protein called PD-L1.

To join the study, participants need to be adults aged 18 or older who have been diagnosed with NSCLC and have not received any treatment yet. They should also be in good overall health, be able to tolerate surgery, and have a life expectancy of at least 12 weeks. Participants will be monitored closely during the trial and will have the opportunity to contribute to important research that could improve lung cancer treatments in the future. It's important to note that this trial is not yet recruiting participants, so those interested will need to wait until it starts.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • The patient shall sign the Informed Consent Form.
• • 1. Aged 18 ≥ years.
• • 2. 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 .
• • 3. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
• • 4. Life expectancy is at least 12 weeks.
• • 5. At least 1 measurable lesion according to RECIST 1.1.
• • 6. Patients with good function of other main organs (liver, kidney, blood system, etc.)
• • 7. Patients with lung function can tolerate surgery;
• • 8. Without systematic metastasis (including M1a, M1b and M1c);
• • 9. 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.
• • 10. 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).
• Exclusion Criteria:
• • 1.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.