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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05991180
Enrollment
160
Registered
2023-08-14
Start date
2023-12-25
Completion date
2025-12-31
Last updated
2023-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extensive-stage Small-cell Lung Cancer

Brief 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.

Interventions

None listed

Sponsors

Hunan Province Tumor Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
ORR2 yearsDefined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects

Secondary

MeasureTime frameDescription
PFS2 yearsDefined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)
OS2 yearsDefined as the time from the start of treatment to the death of the subject due to any cause.

Countries

China

Contacts

Primary ContactYongchang Zhang, MD
zhangyongchang@csu.edu.cn+8613873123436
Backup ContactNong Yang, MD
yangnong0217@163.com+8613873123436

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026