NCT05296603

Brief Summary

This study aimed to explore the efficacy and biomarker explanation of IBI-322 Plus Lenvatinib on extensive stage small cell lung cancer who failed from first line PD-(L)1 inhibitors.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
83

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2021

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

December 3, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 25, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2025

Completed
Last Updated

January 10, 2024

Status Verified

January 1, 2024

Enrollment Period

2.9 years

First QC Date

March 15, 2022

Last Update Submit

January 8, 2024

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • ORR

    Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects

    12 weeks

Secondary Outcomes (2)

  • PFS

    1year

  • OS

    1 year

Study Arms (3)

Cohort A

EXPERIMENTAL

Duration of response time less than 3 months

Drug: IBI-322 Plus Lenvatinib

Cohort B

EXPERIMENTAL

Duration of response time between 3 and 6 months

Drug: IBI-322 Plus Lenvatinib

Cohort C

EXPERIMENTAL

Duration of response time more than 6 months

Drug: IBI-322 Plus Lenvatinib

Interventions

IBI-322 Plus LenvatinibDRUG

IBI322 is based on the "3+3" model, with a dose ascent starting from 10mg

Cohort ACohort BCohort C

Eligibility Criteria

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

You may not qualify if:

  • Patients with contraindication of chemotherapy Pregnant or breast feeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunan Cancer hospital

Changsha, Hunan, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Yongchang C Zhang, MD

CONTACT

+8613873123436zhangyongchang@csu.edu.cn

Nong C Yang, MD

CONTACT

+8613873123436yangnong0217@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of Medical Oncology, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

March 15, 2022

First Posted

March 25, 2022

Study Start

December 3, 2021

Primary Completion

October 30, 2024

Study Completion

December 25, 2025

Last Updated

January 10, 2024

Record last verified: 2024-01

Locations

CN(1)