Neoadjuvant PD-L1/VEGF Bispecific Antibody with Chemo versus Chemo plus PD-1 Monoclonal Antibody in Locally Advanced NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 trial compares two neoadjuvant regimens for stage II-III NSCLC. All participants receive standard chemotherapy with nab-paclitaxel and carboplatin; the experimental arm adds a bispecific antibody targeting PD-L1 and VEGF, while the control arm uses a PD-1 monoclonal antibody. The goal is to improve pathological response and potentially long-term outcomes while preparing for surgical resection. Eligible patients have localized disease without distant metastasis, adequate organ function, and good performance status. Primary endpoint(s) and detailed methodology are described in the protocol.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

1. Patients with lung adenocarcinoma with confirmed EGFR mutations or ALK rearrangements;
2. Histological evidence of small cell components;
3. Patients with other malignant tumors within five years prior to the start of this trial;
4. Having received any systemic anti-cancer treatment for NSCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment, and experimental treatment, etc.;
5. 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;
6. Active, known, or suspected autoimmune diseases, or autoimmune paraneoplastic syndromes requiring systemic treatment;
7. Allergy to the trial drug;
8. Currently diagnosed with interstitial lung disease;
9. Concomitant HIV infection or active hepatitis;
10. Pregnant or lactating women;
11. Patients with neurological or psychiatric disorders who are unable to cooperate;
12. Concurrently participating in another therapeutic clinical study;
13. Other situations deemed unsuitable for enrollment by the investigator.

Where it's running

• Shanghai Changzheng Hospital
  Shanghai, China, China Recruiting
• Huadong Hospital Affiliated to Fudan University
  Shanghai, China, China Recruiting
• Tongji Hospital of Tongji University
  Shanghai, China, China Not yet recruiting
• Shanghai Pulmonary Hospital
  Shanghai, China, China Not yet recruiting
• Shanghai General Hospital
  Shanghai, China, China Not yet recruiting

Study contacts

• Principal investigator: Peng Zhang, PhD — Shanghai Pulmonary Hospital, Shanghai, China
• Study coordinator: Peng Zhang, PhD
• Email: zhangpeng1121@tongji.edu.cn
• Phone: 02165115006

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Radiation-related heart damage in locally advanced NSCLC tested with PET-CT

  This study tests whether PET-CT imaging with 18F-Flurpiridaz can detect early radiation-related heart damage in adults with locally advanced non-small cell lung cancer receiving standard chemoradiation.

  Recruiting Phase 2 Indiana University · Indianapolis, Indiana · NCT07761910

• Targeted Induction Therapy for Stage III Unresectable EGFR Mutant NSCLC

  This trial tests a targeted induction approach using fumetinib with platinum-based chemotherapy and concurrent radiochemotherapy in adults with unresectable stage III EGFR-mutant NSCLC to see if this combo can improve outcomes before possible surgery.

  Recruiting Phase 2 Shanghai Pulmonary Hospital, Shanghai, China · Shanghai, Shanghai Municipality · NCT07742332

• DS-3939a in solid tumors and non-small cell lung cancer

  This study tests DS-3939a, alone or with other anticancer drugs, in adults with solid tumors including locally advanced or metastatic NSCLC to see if it is safe and helps control the disease.

  Recruiting at 3 sites Phase 1/2 Daiichi Sankyo · Fayetteville, Arkansas and 75 other locations · NCT07739966

• Induction chemoimmunotherapy plus chemoradiotherapy and consolidation immunotherapy in unresectable locally advanced NSCLC

  This trial tests induction chemoimmunotherapy followed by chemoradiotherapy and consolidation immunotherapy in adults with unresectable stage III NSCLC to see if it can improve outcomes compared with the standard PACIFIC approach.

  Recruiting Phase 1/2 Shanghai Chest Hospital · Shanghai, Xuhui · NCT07632365

• Neoadjuvant SBRT then sintilimab with chemotherapy for N3-positive locally advanced NSCLC

  This approach tests whether focused radiation to the primary lung tumor followed by two cycles of sintilimab plus platinum-based chemotherapy before surgery can shrink N3-positive locally advanced non-small cell lung cancer and enable curative surgery.

  Recruiting Phase 2 Sun Yat-sen University · Guangzhou, Guangdong · NCT07309952

• NBTXR3 with radiation for locally advanced non-small cell lung cancer

  This study will test whether adding NBTXR3 to radiation helps people with stage I–III non-small cell lung cancer who cannot have chemotherapy or surgery.

  Recruiting Phase 1/2 M.D. Anderson Cancer Center · Houston, Texas · NCT07224152

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.