Phase 2 Lung Cancer Trial, Recruiting NCT07230405 Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Condition: Lung Cancer
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Phase 2 Lung Cancer Trial, Recruiting

NCT07230405
Recruiting Phase 2

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 aged 18 to 75 years at the time of signing the consent form
  • People whose non-small cell lung cancer (a type of lung cancer) has been confirmed by laboratory testing of tissue or cells, and has spread locally or to other parts of the body
  • People who have at least one tumour that can be measured using standard imaging guidelines (known as RECIST v1.1)
  • People whose general health and ability to carry out daily activities is rated as fully active or restricted only in physically strenuous activity (a score of 0 or 1 on a standard scale doctors use)
  • People who the treating doctor expects to survive for at least 12 weeks
  • People whose liver, kidneys, and other organs are functioning well enough (confirm with trial site)
  • People who have recovered from any side effects caused by previous cancer treatments
  • People who agree to use highly effective birth control methods throughout the study treatment period
  • People who voluntarily agree to and sign the informed consent form

Who may not be able to join:

  • People who have cancer that has spread to the brain or spinal cord and is currently active or has not been treated
  • People who have had another type of cancer in the three years before starting the trial
  • People who have a history of serious heart, blood vessel, or blood clot conditions
  • People who have HIV, active hepatitis B, or active hepatitis C
  • People who have uncontrolled fluid build-up around the lungs, heart, or abdomen that keeps needing to be drained
  • People who have a known allergy or sensitivity to the study drug (SKB571) or any of its ingredients
  • People who have serious lung damage from previous lung-related complications
  • People who have had lung inflammation not caused by infection that needed steroid treatment, or who currently have this condition
  • People who have had major surgery within 28 days before starting the trial
  • People who have received a live vaccine within 30 days before starting the trial, or who are expected to receive one during the study
  • People who have taken certain medications that strongly affect how the body processes drugs (called strong CYP3A4 inhibitors or inducers, or BCRP inhibitors) within 2 weeks before starting the trial, or within 5 half-lives of that medication — whichever is longer (confirm with trial site)
  • People who have received chemotherapy, immunotherapy, or biological cancer therapy within 4 weeks before starting the trial
  • People who have an active infection requiring antibiotic or antiviral treatment within 14 days before starting the trial
  • People who have been taking high-dose steroid tablets or other immune-suppressing medications for any condition within 14 days before starting the trial (confirm with trial site for specific dose thresholds)
  • People with any other condition that the treating doctor believes could interfere with the study results or affect the person's safety

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 9 July 2026
Phase 2: approximately ~30% 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: 086-010-58202512

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 2
Sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Registry
ClinicalTrials.gov
Start date
19 January 2026
Est. completion
19 January 2028

Where this trial is recruiting

🇨🇳 China

Primary endpoints

AE; ORR

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: 9 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