NCT05360979

A Clinical Study of Immunotherapy Combined With Chemotherapy and Anti-angiogenic Therapy in Operable NSCLC

A Prospective, Single-arm Clinical Study of Envafolimab Combined With Chemotherapy and Recombinant Human Endostatin in Patients With Operable Stage II, IIIA, and IIIB (T3N2) Non-small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Second Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The objective of this prospective, single-arm, single-center clinical study is to evaluate the efficacy and safety of envafolimab combined with platinum-containing dual-drug chemotherapy and recombinant human endostatin regimens for treating patients with operable II, IIIA, and IIIB (T3N2) stage NSCLC.

Detailed description

Patients with stage II, IIIA, and IIIB (T3N2) NSCLC that did not previously receive systemic treatment and can be treated with surgery were recruited. After signing the informed consent, eligible subjects who meet the inclusion criteria will receive neoadjuvant therapy comprising envafolimab combined with platinum-containing chemotherapy and recombinant human endostatin, as well as postoperative envafolimab single-agent adjuvant therapy. During the preoperative neoadjuvant therapy period, 3 cycles of envafolimab (300 mg fixed-dose Q3W) with recombinant human endostatin (210 mg, CIV \[continuous intravenous pump injection\], 72 h, Q3W), and platinum-containing dual-drug chemotherapy (Q3W) will be performed, with a dosing cycle performed every 3 weeks. The study drug will be administered on the first day of each cycle. All subjects will undergo preoperative imaging evaluation and surgical indication evaluation at 3-5 weeks after the third cycle of preoperative medication. After completing the first 3 cycles of neoadjuvant therapy, all subjects persistently presenting indications for surgery will undergo radical surgery for NSCLC within 4-6 weeks according to the standards defined by the World Association for the Study of Lung Cancer. The pathological staging will be performed according to the AJCC Cancer Staging Manual (8th edition). Local pathologists will evaluate the surgical margins of all specimens removed during the operation. Tumor tissue samples collected from subjects during the research process will be submitted to the designated central laboratory for pathological remission assessment and translational research. Postoperative envafolimab monotherapy (300 mg, Q3W) will be initiated at 4-6 weeks post-surgery and maintained for 1 year Adverse events (AE) will be monitored throughout the study period, and the severity of AEs will be assessed according to the guidelines listed in the National Cancer Institute (NCI) Commonly Used Terminology Criteria for Adverse Events (CTCAE) version 5.0 or above. Safety follow-ups will be conducted for all patients receiving treatment and those who warrant early discontinuation. All subjects will be followed up for OS until death, withdrawal of informed consent, or the end of the study.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	envafolimab	Envafolimab: 300 mg, D1, Q3W, subcutaneously administered

Timeline

• Start date: 2022-05-15
• Primary completion: 2023-05-15
• Completion: 2025-05-15
• First posted: 2022-05-04
• Last updated: 2022-05-04

Locations

1 site across 1 country: China