Phase 1 Lung Cancer Trial, Recruiting NCT06613009 Sponsor: Innovent Biologics (Suzhou) Co. Ltd. Condition: Lung Cancer
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Phase 1 Lung Cancer Trial, Recruiting

NCT06613009
Recruiting Phase 1 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are able to understand and sign a written consent form agreeing to take part in the trial and all its procedures
  • People aged 18 or older (for the first part of the trial, participants must be between 18 and 75 years old)
  • People whose general physical health and ability to carry out daily activities is rated as good or fully active (scored 0 or 1 on a standard medical scale)
  • People with a life expectancy of at least 12 weeks
  • People whose liver, kidneys, and other organs are working well enough, as confirmed by tests done at the start of the trial
  • People who have been diagnosed through laboratory testing with small cell lung cancer (SCLC) that cannot be removed by surgery, has spread to other parts of the body, or is at an advanced stage

Who may not be able to join:

  • People who are currently taking part in another clinical trial that involves an active treatment or intervention (observational studies or follow-up phases of a previous trial may be acceptable — confirm with trial site)
  • People who still have side effects from previous cancer treatments that have not improved to a mild or resolved level, with some exceptions such as hair loss or fatigue that the doctor considers low risk
  • People with a known allergy or sensitivity to the study drug IBI3009 or any of its ingredients
  • People who have had major surgery (such as brain, chest, or abdominal surgery) within the 4 weeks before starting the trial, who are expected to have major surgery during the trial, or who have serious wounds, injuries, or ulcers that have not healed
  • People who are pregnant, have a positive pregnancy test, or are currently breastfeeding
  • People who the trial doctor considers unsuitable to participate for any other reason

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: +86 18507159591

Australian sites

Westmead Hospital, Westmead, New South Wales
0422 050 656
Wollongong Hospital, Wollongong, New South Wales
Austin Hospital, Heidelberg, Victoria

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Registry
ClinicalTrials.gov
Start date
30 December 2024
Est. completion
30 August 2027

Where this trial is recruiting

🇦🇺 Australia 🇨🇳 China

3 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Numbers of subjects with adverse events; Number of subjects with clinically significant changes in physical examination results; Number of subjects with clinically significant changes in electrocardiogram; Number of subjects with clinically significant changes in vital signs; Dose limiting toxicities (DLTs)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov