NCT07177716

Brief 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
31mo left

Started Oct 2025

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Oct 2025Dec 2028

First Submitted

Initial submission to the registry

September 4, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 17, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

3.2 years

First QC Date

September 4, 2025

Last Update Submit

September 10, 2025

Conditions

Cervical Cancer

Keywords

cervical carcinomaLB1410LB4330

Outcome Measures

Primary Outcomes (2)

  • Objective Response Rate (ORR) assessed by an Independent Radiology Review Committee (IRRC)

    defined as the percentage of patients with a best overall response of Complete Response or Partial Response per RECIST 1.1.

    Approximately 24 months

  • Duration of Response (DOR) assessed by an Independent Radiology Review Committee (IRRC)

    defined as the time from the first documented response (CR or PR) to the first documented disease progression or death due to underlying cancer per RECIST 1.1.

    Approximately 24 months

Secondary Outcomes (10)

  • Objective Response Rate (ORR) assessed by the investigator

    Approximately 24 months

  • Duration of Response (DOR) assessed by the investigator

    Approximately 24 months

  • Disease Control Rate (DCR)

    Approximately 24 months

  • Progression-Free Survival (PFS)

    Approximately 24 months

  • Overall Survival (OS)

    Until participant death/end of study,approximately 24 months

  • +5 more secondary outcomes

Other Outcomes (2)

  • Biomarker(TIM3)

    Until end of study,approximately 24 months

  • Biomarker(PD-L1)

    Until end of study,approximately 24 months

Study Arms (4)

Cohort 1: LB1410 + Lenvatinib

EXPERIMENTAL

LB1410 (intravenous, Q2W) with lenvatinib (oral, QD),up to 2 years

Biological: LB1410Drug: Lenvatinib

Cohort 2: LB1410 + LB4330 + Lenvatinib

EXPERIMENTAL

LB1410 (IV, Q2W for up to 2 years), LB4330 (IV, Q2W for 4 cycles), and lenvatinib (oral, once daily for up to 2 years)

Biological: LB1410Biological: LB4330Drug: Lenvatinib

Cohort 3: LB1410

EXPERIMENTAL

LB1410 (IV, Q2W for up to 2 years)

Biological: LB1410

Cohort 4: LB1410 + LB4330

EXPERIMENTAL

LB1410 (IV, Q2W for up to 2 years) plus LB4330 (IV, Q2W for 4 cycles)

Biological: LB1410Biological: LB4330

Interventions

LB1410BIOLOGICAL

LB1410 (IV, Q2W for up to 2 years)

Cohort 1: LB1410 + LenvatinibCohort 2: LB1410 + LB4330 + LenvatinibCohort 3: LB1410Cohort 4: LB1410 + LB4330
LB4330BIOLOGICAL

LB4330 (IV, Q2W for 4 cycles)

Cohort 2: LB1410 + LB4330 + LenvatinibCohort 4: LB1410 + LB4330
LenvatinibDRUG

lenvatinib (oral, once daily for up to 2 years)

Cohort 1: LB1410 + LenvatinibCohort 2: LB1410 + LB4330 + Lenvatinib

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed cervical squamous cell carcinoma, adenosquamous carcinoma, or HPV-associated cervical adenocarcinoma.
  • Recurrent or metastatic cervical cancer with disease progression or intolerable toxicity after standard therapy, with no more than three prior lines of systemic therapy in the recurrent or metastatic setting, with only one prior line of therapy containing anti-PD-1/anti-PD-L1 agents.
  • At least one measurable lesion per RECIST v1.1 at screening period.
  • Age ≥18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Investigator-assessed life expectancy ≥12 weeks.
  • Adequate hematological function, liver function, renal function and coagulation function.
  • Adequately controlled blood pressure (BP) with or without antihypertensive medication.
  • Any related toxicity or prior adverse events (AEs) had recovered to baseline or ≤Grade 1 per NCI CTCAE v5.0.
  • Women of childbearing potential must agree to use effective contraception from the time of signing the informed consent form, throughout the study, and for 6 months after the last dose of study treatment.
  • The patient is capable of understanding and voluntarily signing the informed consent form.

You may not qualify if:

  • For cohorts containing lenvatinib, patients meeting any of the following criteria are ineligible:
  • Radiographic (CT or MRI) evidence of tumor invasion around major blood vessels, or investigator judgment that the tumor is highly likely to invade major blood vessels during the study, leading to life-threatening hemorrhage;
  • History of bleeding, coagulation disorders, or current use of warfarin, aspirin, or other antiplatelet agents;
  • Urine protein ≥2+ and 24-hour urine protein quantification ≥1.0 g;
  • Factors affecting oral drug absorption;
  • Intestinal metastases or existing ≥Grade 3 gastrointestinal or non-gastrointestinal fistulas;
  • History of hypertensive crisis or hypertensive encephalopathy.
  • Pregnant or breastfeeding women.
  • History of ≥Grade 3 immune-related adverse events (irAEs) during prior immunotherapy.
  • Active autoimmune disease or symptomatic autoimmune disease.
  • Any of the following prior treatments:
  • Live or attenuated live vaccines within 4 weeks before the first dose;
  • Immunomodulatory drugs (e.g., thymosin, interleukin-2, interferon) within 14 days before the first dose;
  • History of allogeneic organ transplantation, allogeneic peripheral hematopoietic stem cell transplantation, or bone marrow transplantation.
  • Positive HIV test, active syphilis, active hepatitis B virus (HBV) infection, or active hepatitis C virus (HCV) infection.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Xiaohua Wu, Doctor

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Luan, Doctor

CONTACT

86-21-54152522luanyn2@lnlbio.com

Xiaohua Wu, Doctor

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2025

First Posted

September 17, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

September 17, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)