NCT05387109

Penpulimab Combined With Anlotinib in Neoadjuvant Treatment of Resectable Non-small Cell Lung Cancer

An Exploratory Study of Penpulimab Combined With Anlotinib in Neoadjuvant Treatment of Resectable Stage II-IIIB Non-small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sponsor: Tang-Du Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Neoadjuvant therapy with penpulimab combined with anlotinib;with surgery within 4-6 weeks after drug withdrawal;Adjuvant therapy within 4-12 weeks after surgery

Detailed description

1. Neoadjuvant therapy with penpulimab combined with anlotinib penpulimab: fixed dose of 200 mg, administered on the first day of each cycle, repeated every 3 weeks; Anlotinib: 12 mg, administered on days 1-14, orally once a day, about half an hour before breakfast (the daily dose should be as much as possible), taken with warm water, and repeated every 3 weeks. 2. operation treatment: Each subject will receive 3 cycles of study treatment, with surgery within 4-6 weeks after drug withdrawal. 3. Suggested dosing regimen in the adjuvant therapy phase: It is recommended to give patients corresponding adjuvant therapy after surgery, and the specific adjuvant therapy plan will be formulated by the investigator according to the individual situation of the patient. The postoperative adjuvant therapy in this protocol is for reference only: complete pre-dose examination within 4-12 weeks after surgery, and conduct pre-administration evaluation of adjuvant therapy; use platinum-based chemotherapy (cisplatin: 75mg/m2, d1, Q3W, 4 cycles; in combination with docetaxel: 75mg/m2, d1, Q3W, 4 cycles, or in combination with pemetrexed: 500mg/m2, d1, Q3W, 4 cycles (for non-squamous cell carcinoma only) row 4 cycle of adjuvant therapy; then continued adjuvant single-agent penicillimab (200 mg, day 1, Q3W) for 1 year or until disease progression. If the following conditions occur during the treatment, such as the subject's disease progression, drug toxicity and side effects intolerable, withdrawal of informed consent, etc., the patient will terminate the treatment. During the trial, the efficacy indicators and safety indicators were observed.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	penpulimab combined with anlotinib	penpulimab: fixed dose of 200 mg, administered on the first day of each cycle, repeated every 3 weeks; Anlotinib: 12 mg, administered on days 1-14, orally once a day, about half an hour before breakfast (the daily dose should be as much as possible), taken with warm water, and repeated every 3 weeks

Timeline

• Start date: 2022-06-30
• Primary completion: 2023-04-20
• Completion: 2024-04-20
• First posted: 2022-05-24
• Last updated: 2022-05-24