Locally Advanced Non-Small Cell Lung CancerPhase 3NCT07863999
Neoadjuvant Chemotherapy Combined With Bispecific Antibody Versus Combined With Monoclonal Antibody in Locally Advanced NSCLC
A Phase 3 study testing PD-L1/VEGF Bispecific Antibody, PD-1 Monoclonal Antibody and Nab-paclitaxel in people with Locally Advanced Non-Small Cell Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China at 5 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Non-Small Cell Lung Cancer
- What is being tested?
- PD-L1/VEGF Bispecific Antibody, PD-1 Monoclonal Antibody and Nab-paclitaxel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 5 sitesChina
- Study dates
- 1 May 2026to 1 Dec 2033
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- Patients with lung adenocarcinoma with confirmed EGFR mutations or ALK rearrangements;
- Histological evidence of small cell components;
- 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;
- Active, known, or suspected autoimmune diseases, or autoimmune paraneoplastic syndromes requiring systemic treatment;
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- Allergy to the trial drug;
- Currently diagnosed with interstitial lung disease;
- Concomitant HIV infection or active hepatitis;
- Pregnant or lactating women;
- Patients with neurological or psychiatric disorders who are unable to cooperate;
- Concurrently participating in another therapeutic clinical study;
- Other situations deemed unsuitable for enrollment by the investigator.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Shanghai Changzheng Hospital
Shanghai, China, 200003
Hao Tang, PhD
- Recruiting
Huadong Hospital Affiliated to Fudan University
Shanghai, China, 200040
Xiaoyong, Shen
- Not yet recruiting
Tongji Hospital of Tongji University
Shanghai, China, 200333
Yongxin Zhou, PhD
- Not yet recruiting
Shanghai Pulmonary Hospital
Shanghai, China, 200433
Peng Zhang, PhD, zhangpeng1121@tongji.edu.cn
- Not yet recruiting
Shanghai General Hospital
Shanghai, China, 201620
Zheng Ruan, PhD
About this study
Official title: 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.
- Being tested
- PD-L1/VEGF Bispecific Antibody, PD-1 Monoclonal Antibody, Nab-paclitaxel, Carboplatin, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-L1/VEGF Bispecific AntibodyDrug
Specified dose on specified days.
PD-1 Monoclonal AntibodyDrug
Specified dose on specified days.
Nab-paclitaxelDrug
Specified dose on specified days.
CarboplatinDrug
Specified dose on specified days.
SurgeryProcedure or surgery
Patients with resectable tumor after neoadjuvant therapy will be treated with surgery.
| Study group | Role | What they receive |
|---|---|---|
| Bispecific Antibody | Experimental | Patients with locally advanced Non-small cell lung cancer will be randomized into this arm (145 patients) and receive 4 circles of neoadjuvant PD-L1/VEGF Bispecific Antibody combined with platinum-based doublet chemotherapy and those resectable after neoadjuvant therapy will be treated with surgery. Receives: Drug: PD-L1/VEGF Bispecific Antibody; Drug: Nab-paclitaxel; Drug: Carboplatin; Procedure: Surgery |
| Monoclonal Antibody | Active comparator | Patients with locally advanced Non-small cell lung cancer will be randomized into this arm (145 patients) and receive 4 circles of neoadjuvant PD-1 Monoclonal Antibody combined with platinum-based doublet chemotherapy and those resectable after neoadjuvant therapy will be treated with surgery. Receives: Drug: PD-1 Monoclonal Antibody; Drug: Nab-paclitaxel; Drug: Carboplatin; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response (PCR) rate
PCR rate is defined as the proportion of participants who have achieved pathologic complete response (on routine hematoxylin and eosin staining, no tumor cell can be found in tumor bed or lymph node) in all participants.
Measured: Up to 30 months
Secondary outcomes (6)
Event-free survival (EFS)
Event-free survival (EFS) is defined as the length of time (months) from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Measured: Up to 60 months
Overall survival (OS)
It is defined as the time (months) from enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date.
Measured: Up to 60 months
Major pathologic response (MPR) rate
MPR rate is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants.
Measured: Up to 30 months
Objective response rate (ORR)
ORR is defined according to the RECIST v1.1 criteria.
Measured: Up to 30 months
Treatment-related adverse event (TRAE)
TRAE is defined and classified according to NCI-CTCAE v5.0 in all participants.
Measured: Up to 30 months
Health related quality of life (HRQol) composite
The assessment is made according to the Quality of Life Scale for Lung Cancer Patients (EORTC-QLQ-C30 \& LC13, Version 3). EORTC's QLQ-C30 \& LC13 (V3.0) is a core scale for lung cancer patients, with a total of 43 items. Among them, Item 29 and 30 are divided into seven grades, which are assigned with 1 to 7 scores according to the answer options. The other items are divided into 4 grades: Not at All, A Little, Quite a Bit, and Very Much, assigned with 1 to 4 scores respectively. The higher score, the worse quality.
Measured: Up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start1 May 2026
- Primary completion1 Dec 2033 (estimated)
- Study completion1 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Zhang, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Peng Zhang, PhD, Principal investigator, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863999
- Sponsor's protocol ID
- LungMate-034
- Status last verified
- Oct 2025
- First submitted
- 7 May 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The researchers will consider whether IPD is available to other researchers only after the paper is published