IBI115 in Advanced Small Cell Lung Cancer (SCLC) explores safety and early activity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multi-regional, open-label Phase 1 trial evaluating the safety, tolerability, and preliminary activity of IBI115 as a single agent and in combination therapy for adults with advanced small cell lung cancer. Participants must have measurable disease, good performance status, and adequate organ function. The study screens for eligibility and monitors adverse events, tumor response by RECIST, and preliminary efficacy signals to guide further development. Enrollment is at a single site in Chongqing, China, sponsored by Innovent Biologics with collaboration from the hospital site.

Why it matters

Who can join: the full rules

Inclusion Criteria：

1. Participants must be able to understand and sign the written informed consent form for participation in this trial, including all evaluations and procedures specified in this protocol.
2. Male or female participants aged ≥18 years and ≤75 years.
3. Participants with histologically or cytologically confirmed advanced small cell lung cancer.
4. At least one measurable lesion according to RECIST V1.1 within 28 days prior to the first dose of IBI115.
5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
6. Expected survival period ≥12 weeks.
7. Adequate bone marrow and organ function confirmed during the screening period.

Exclusion Criteria：

1. Concurrent participation in another interventional clinical study, except for observational non-interventional studies or being in the survival follow-up phase of an interventional study.
2. Administration of a live vaccine within 4 weeks prior to the first dose of the study drug or a cancer vaccine within 3 months prior, or planning to receive any live vaccine during the study period.
3. Adverse reactions from prior anti-tumor therapy that have not resolved to CTCAE v6.0 Grade 0, Grade 1, or baseline levels by the time of the first dose of the study drug.
4. Known hypersensitivity or intolerance to IBI115, sintilimab, or any of their excipients.

Where it's running

• the second affiliated hospital of AMU
  Chongqing, Chongqing Municipality, China Recruiting

Study contacts

• Study coordinator: Xiao Zhang
• Email: kobe.zhang@innoventbio.com
• Phone: +86 021 3183 7200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.