Phase 2 Lung Cancer Trial, Recruiting NCT05468242 Sponsor: Sun Yat-sen University Condition: Lung Cancer
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Phase 2 Lung Cancer Trial, Recruiting

NCT05468242
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:

  • You are willing and able to sign a consent form before any study procedures begin
  • You are between 18 and 75 years old
  • You have been diagnosed with non-small cell lung cancer (NSCLC) that has been confirmed by a tissue or cell sample, and the cancer is at a locally advanced stage (Stage III)
  • You have not previously received chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy for this cancer
  • A recent sample of your tumour may be requested, if it is safe and technically possible to obtain one
  • Your doctors expect you to live for at least 12 weeks
  • You are generally well enough to carry out light activity (your doctor will assess this using a standard scale)
  • If you are a woman who has not gone through menopause, you must have a negative pregnancy test within 14 days before starting the study drug
  • You are not currently breastfeeding
  • Your lung breathing test shows a strong enough airflow (confirm with trial site)
  • Your blood tests show that your white blood cells, platelets, and red blood cells are at acceptable levels
  • Your kidneys and liver are functioning well enough, based on blood test results

Who may not be able to join:

  • You are already taking part in another clinical trial that involves a treatment or intervention
  • Your lung cancer has features of both small cell and non-small cell types
  • You have taken immune-suppressing medicines in the 28 days before starting the study drug (with some exceptions for low-dose or inhaled steroids — confirm with trial site)
  • You have previously been treated with a type of immunotherapy that targets PD-1 or PD-L1 proteins
  • You have had major surgery within the 4 weeks before joining the study
  • You have or have had an autoimmune disease (where the immune system attacks the body) within the last 2 years
  • You have or have had inflammatory bowel disease, such as Crohn's disease or ulcerative colitis
  • You have a condition where your immune system does not work properly from birth
  • You have had an organ transplant that requires you to take immune-suppressing medicines
  • Your tumour has completely surrounded or grown into major blood vessels near the heart or lungs
  • You have a tendency to bleed easily or a blood clotting disorder
  • You have had a serious heart or blood pressure crisis, stroke, or significant heart failure within the last 6 months
  • Your blood pressure is not well controlled (consistently above 150/100 mmHg)
  • You have had major surgery within the last 28 days, or minor surgery or a needle biopsy within the last 48 hours
  • Your urine tests show a high level of protein in your urine
  • Your heart's electrical activity (measured by an ECG) shows a certain abnormality (confirm with trial site)
  • You have an uncontrolled serious illness, active infection, unstable heart condition, active stomach ulcer, or a mental health condition that might affect your ability to follow the study requirements
  • You have a known history of hepatitis B, hepatitis C, or HIV
  • You have a known history of tuberculosis
  • You have received a live vaccine within 30 days before joining the study or starting the study drug
  • You have been diagnosed with another cancer within the last 5 years, with some exceptions such as certain treated skin cancers or cervical conditions (confirm with trial site)
  • You are pregnant or could become pregnant and are not using an effective method of contraception, or you are a male patient of reproductive age not using effective contraception
  • Your doctor feels there is any other reason you should not take part in this study

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 30 June 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.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
1 January 2022
Est. completion
30 December 2024

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Progression free survival

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: 30 June 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