Neoadjuvant PD-1 Antibody Plus Apatinib or Chemotherapy for Non-small Cell Lung Cancer
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- STATUS
- Recruiting
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- End date
- Dec 30, 2026
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- participants needed
- 99
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- sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
Summary
Immunotherapy with anti-programmed death 1 (PD-1) antibodies has revolutionized the treatment of metastatic and advanced NSCLC, but its application in neoadjuvant setting has not been well established. Results from a pilot clinical study reported the safety and feasibility of neoadjuvant PD-1 blockade. There are several neoadjuvant immunotherapy (NEOSTAR, LCMC3, NADIM, IMpower131) ongoing, and the preliminary results are reported in 2019 American Society of Clinical Oncology, which show promising therapeutic prospect. However, the therapeutic response rate (major pathologic response [MPR]) are not so good (20% - 45%) for PD-1 inhibitor monotherapy. To improve the therapeutic response, the investigators design a multiple-canter, open-label, phase II trial for stage II-IIIA resectable NSCLC. The participants will receive neoadjuvant PD-1 inhibitor (camrelizumab) combined with antiangiogenic drug (apatinib) or platinum-based chemotherapy.
Description
Detailed Description:
This is a multiple-canter, open-label, phase II trial, 2-4 cycles treatment will be planned as neo-adjuvant therapy for NSCLC participants in stage II-IIIA.
Study design:
Participants: Newly diagnosed Resectable II-IIIA NSCLC without EGFR/ALK/ROS1/BRAF mutation.
- Treatment
Group Acamrelizumab 200 mg q3w i.v. for 2-4 cycles, apatinib 250mg pd po 3w/cycle for 2-4 cycles before surgery; Group Bcamrelizumab 200 mg q3w i.v. for 2-4 cycles, platinum-based chemotherapy q3w i.v for 2-4 cycles before surgery.
- Endpoints
Primary objectives are to assess MPR and safety. Secondary objective is to assess 2-year overall survival (OS), disease-free survival (DFS), OS etc.
Exploratory end point is to explore biomarkers.
Details
| Condition | Non-Small Cell Lung Cancer, Non-Small Cell Lung Cancer |
|---|---|
| Age | 18years - 75years |
| Treatment | Camrelizumab |
| Clinical Study Identifier | NCT04379739 |
| Sponsor | Shanghai Pulmonary Hospital, Shanghai, China |
| Last Modified on | 19 February 2024 |
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