Real-World Study on the Efficacy of IBI-322 in Combination With Lenvatinib for the Treatment of Extensive Stage Small Cell Lung Cancer

Extensive-stage Small-cell Lung Cancer Clinical Trial

Official title:

Real-World Study on the Efficacy of IBI-322 in Combination With Lenvatinib for the Treatment of Extensive Stage Small Cell Lung Cancer and Assessment of Biomarkers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05991180
• Other study ID #: BELIEVE RWS
• Status: Recruiting
• Start date: December 25, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: Hunan Province Tumor Hospital
• Contact: Yongchang Zhang, MD
• Phone: +8613873123436
• Email: zhangyongchang[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a descriptive observational study, in which data are collected in an epidemiological fashion and prospective. This study does not intend to intervene the current medical practice of the recruited patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 31, 2025
• Est. primary completion date: December 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must be =18 years.

• Provision of fully informed consent prior to any study specific procedures.

• Patients with extensive stage SCLC diagnosed by pathology (as staged by the American Veterans Lung Cancer Association (VALG)), who do not have an imaging response during first-line treatment with PD-(L)1 inhibitors, or who progress after imaging reactions on first-line therapy (the most recent regimen prior to enrollment must contain PD-(L)1 inhibitors).

• According to the RECIST 1.1 standard, the patient must have at least one measurable lesion.

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Extensive-stage Small-cell Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Locations

Country	Name	City	State
China	Hunan Cancer hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Province Tumor Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects	2 years
Secondary	PFS	Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)	2 years
Secondary	OS	Defined as the time from the start of treatment to the death of the subject due to any cause.	2 years