Two Antibody Drugs With Chemotherapy Before Surgery for Locally Advanced Lung Cancer
Compares two antibody drugs given with chemotherapy before surgery in non-small cell lung cancer.
Plain-language title generated from the registry record
Registry title: Neoadjuvant Chemotherapy Combined With Bispecific Antibody Versus Combined With Monoclonal Antibody in Locally Advanced NSCLC
Key facts
- Where
- Shanghai, ChinaSee the 5 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with stage II-III non-small cell lung cancer who have not yet had any cancer treatment and can have surgery.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Non-small cell lung cancer, stage II-III, confirmed by biopsy and imaging, with at least 1 measurable tumour and no spread to other parts of the body
- Earlier treatment
- No earlier anti-cancer treatment of any kind
Main reasons for not taking part
- Lung adenocarcinoma with a known EGFR mutation or ALK rearrangement
- Small cell cancer cells found in the tumour
- Another cancer within the last five years
- Active autoimmune disease or interstitial lung disease
- HIV infection, active hepatitis, or being pregnant or breastfeeding
Read by machine on 12 November 2026.
Where in China
- Huadong Hospital Affiliated to Fudan UniversityShanghai, ChinaContact: Xiaoyong, ShenTaking people
- Shanghai Changzheng HospitalShanghai, ChinaContact: Hao Tang, PhDTaking people
- Shanghai General HospitalShanghai, ChinaContact: Zheng Ruan, PhDNot yet recruiting
- Shanghai Pulmonary HospitalShanghai, ChinaContact: Peng Zhang, PhDNot yet recruiting
- Tongji Hospital of Tongji UniversityShanghai, ChinaContact: Yongxin Zhou, PhDNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Shanghai Pulmonary Hospital, Shanghai, China
- Trial code
- NCT07863999
- Record updated
- 7 October 2026
- Original description
Surgical intervention remains the primary treatment option for early-stage lung cancer. With the proven efficacy of immunotherapy in the treatment of advanced non-small cell lung cancer (NSCLC), neoadjuvant immunotherapy has increasingly become a focal point of research. Blocking vascular endothelial growth factor (VEGF) not only inhibits the proliferation of vascular endothelial cells and the formation of new blood vessels but also improves the tumor microenvironment and enhances the infiltration of cytotoxic T lymphocytes within it. Simultaneously targeting the VEGF and PD-L1 pathways can create a synergistic anti-cancer effect. PM8002 injection is a bispecific antibody drug that targets both PD-L1 and VEGF, functioning as a dual-action agent that combines immune suppression and anti-angiogenesis. In patients with locally advanced stage II-III NSCLC, neoadjuvant therapy that concurrently targets PD-L1/VEGF in combination with chemotherapy can improve pathological response rates, provided that the safety of the drug combination is maintained. This approach offers additional benefits to patients, prolongs event-free survival (EFS), and improves prognosis.Read full original descriptionShow less
Neoadjuvant Chemotherapy Combined With PD-L1/VEGF Bispecific Antibody Versus Combined With PD-1 Monoclonal Antibody in Locally Advanced Non-Small Cell Lung Cancer: A Multicenter, Randomized Controlled Clinical Trial
Surgical intervention remains the primary treatment option for early-stage lung cancer. With the proven efficacy of immunotherapy in the treatment of advanced non-small cell lung cancer (NSCLC), neoadjuvant immunotherapy has increasingly become a focal point of research. Blocking vascular endothelial growth factor (VEGF) not only inhibits the proliferation of vascular endothelial cells and the formation of new blood vessels but also improves the tumor microenvironment and enhances the infiltration of cytotoxic T lymphocytes within it. Simultaneously targeting the VEGF and PD-L1 pathways can create a synergistic anti-cancer effect. PM8002 injection is a bispecific antibody drug that targets both PD-L1 and VEGF, functioning as a dual-action agent that combines immune suppression and anti-angiogenesis. In patients with locally advanced stage II-III NSCLC, neoadjuvant therapy that concurrently targets PD-L1/VEGF in combination with chemotherapy can improve pathological response rates, provided that the safety of the drug combination is maintained. This approach offers additional benefits to patients, prolongs event-free survival (EFS), and improves prognosis.
Inclusion: The patient shall sign the Informed Consent Form; Aged 18 ≥ years; Histological or cytological diagnosis of NSCLC by needle biopsy, and stage II-III confirmed by imageological examinations (CT, PET-CT or EBUS)，and have not previously received anti-tumor treatment; 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 toripalimab (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 toripalimab (whichever is later).
Exclusion: Patients with other malignant tumors within five years prior to the start of this trial; Having received any systemic anti-cancer treatment for NSCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment, and experimental treatment, etc; Concomitant unstable systemic diseases, including active infections, uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg), unstable angina, angina that started within the last 3 months, congestive heart failure (≥New York Heart Association [NYHA] Class II), myocardial infarction (within 6 months prior to enrollment), severe arrhythmias requiring drug treatment, liver, kidney, or metabolic diseases; Concomitant HIV infection or active hepatitis; Active, known, or suspected autoimmune diseases, or autoimmune paraneoplastic syndromes requiring systemic treatment; Allergy to the trial drug; Currently diagnosed with interstitial lung disease; Patients with neurological or psychiatric disorders who are unable to cooperate; Patients with lung adenocarcinoma with confirmed EGFR mutations or ALK rearrangements; Histological evidence of small cell components; Pregnant or lactating women; Concurrently participating in another therapeutic clinical study; Other situations deemed unsuitable for enrollment by the investigator.