NCT07177716

Efficacy and Safety of LB1410 Plus Lenvatinib With or Without LB4330 in Advanced Recurrent/Metastatic Cervical Cancer

A Multicenter, Randomized, Open-Label Phase II/III Clinical Study on the Efficacy and Safety of LB1410 Plus Lenvatinib With or Without LB4330 Versus Investigator's Choice of Chemotherapy in Advanced Recurrent/Metastatic Cervical Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: L & L Bio Co., Ltd., Ningbo, China · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, open-label Phase II/III clinical study, aiming to evaluate the efficacy and safety of LB1410 in combination with lenvatinib (whether in combination with LB4330）versus the chemotherapy regimen selected by the investigators for patients with advanced recurrent/metastatic cervical cancer.

Detailed description

This study is an open-label, multicenter Phase II/III clinical trial in advanced/metastatic cervical cancer to evaluate the antitumor efficacy, safety, tolerability, pharmacokinetics (PK), and biomarkers of LB1410 in combination with lenvatinib, with or without LB4330.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
BIOLOGICAL	LB1410	LB1410 (IV, Q2W for up to 2 years)
BIOLOGICAL	LB4330	LB4330 (IV, Q2W for 4 cycles)
DRUG	Lenvatinib	lenvatinib (oral, once daily for up to 2 years)

Timeline

• Start date: 2025-10-01
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2025-09-17
• Last updated: 2025-09-17

Locations

1 site across 1 country: China