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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Extensive-stage Small-cell Lung Cancer

• Study Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

• Study Contact: Name: Yongchang Zhang, MD; Phone Number: +8613873123436; Email: zhangyongchang@csu.edu.cn
• Study Contact Backup: Name: Nong Yang, MD; Phone Number: +8613873123436; Email: yangnong0217@163.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Hunan Cancer Hospital
      • Contact: Yongchang Zhang, MD; Phone Number: +86 731 89762321; Email: zhangyongchang@csu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Extensive Stage Small Cell Lung Cancer

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)	2 years
OS	Defined as the time from the start of treatment to the death of the subject due to any cause.	2 years

Collaborators and Investigators

• Sponsor: Hunan Province Tumor Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 25, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 6, 2023
• First Submitted That Met QC Criteria: August 6, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 25, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: BELIEVE RWS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No