Lung Cancer Trial, Recruiting NCT07565532 Sponsor: Shanghai Chest Hospital Condition: Lung Cancer
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Lung Cancer Trial, Recruiting

NCT07565532
Recruiting Not Applicable

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:

For people with limited-stage small cell lung cancer (LS-SCLC):

  • People who have given voluntary, signed consent to take part, following standard clinical practice.
  • People whose small cell lung cancer has been confirmed by tissue biopsy and imaging, and who have not yet received any treatment for it, and whose disease is classified as "limited-stage."
  • People aged 18 or older.
  • People with a life expectancy of at least 8 weeks.
  • People whose general physical fitness is rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity — confirm with trial site).
  • People who have had at least one recorded assessment of how their cancer is responding to treatment.
  • People who have at least one tumour that can be measured on scans, as confirmed by the study doctor using standard measurement guidelines.
  • People whose blood counts, kidney function, liver function, and blood clotting results fall within acceptable ranges on tests done within 7 days before the first dose, without having needed blood transfusions or certain boosting treatments in the 14 days before those tests (confirm specific values with trial site).
  • People whose breathing test shows adequate lung function (a specific airflow measure above a set level — confirm with trial site).
  • People who do not have signs of severe lung scarring on CT or PET/CT scan before treatment.
  • People who do not have another active cancer at the same time.
  • A specific protein test (PD-L1) result is not required for eligibility.

For people with extensive-stage small cell lung cancer (ES-SCLC):

  • People who have given voluntary, signed consent to take part.
  • People whose small cell lung cancer has been confirmed by tissue biopsy, with full staging tests showing the disease is "extensive-stage."
  • People aged 18 or older.
  • People with a life expectancy of at least 8 weeks.
  • People who have had at least one recorded assessment of how their cancer is responding.
  • People whose general physical fitness is rated as 0, 1, or 2 on a standard medical scale (meaning fully active through to being up and about for more than half the day — confirm with trial site).
  • People whose blood counts, kidney function, liver function, and blood clotting results fall within acceptable ranges on tests done within 7 days before the first dose, without having needed blood transfusions or certain boosting treatments in the 14 days before those tests (confirm specific values with trial site).
  • People without serious ongoing medical conditions.
  • People whose breathing test shows adequate lung function (confirm with trial site).
  • People who previously had radiotherapy to the main tumour site, where any new radiotherapy planned for this trial would only target areas where the cancer has spread.
  • People who do not have another active cancer at the same time.
  • A specific protein test (PD-L1) result is not required for eligibility.
  • People who were previously treated with the intention of curing limited-stage SCLC, but whose cancer has since come back or spread, and who have never previously received immunotherapy, may still be considered for the extensive-stage group if full staging information is available.

Who may not be able to join:

For people with limited-stage small cell lung cancer (LS-SCLC):

  • People whose lung cancer has been confirmed as non-small cell lung cancer (a different type).
  • People with no recorded tumour assessment, or where that assessment data is missing.
  • People who have another active cancer, or who have had an organ transplant using a donor organ.
  • People who had major surgery (not including a diagnostic biopsy) within 4 weeks before the first dose.
  • People with a history of substance or drug addiction, long-term heavy alcohol use, or who have HIV/AIDS.
  • People with an active autoimmune disease, or a history of one that could return.
  • People currently taking corticosteroid medicines at higher doses (equivalent to more than 10 mg of prednisone per day), or who have taken any immunosuppressant medicines within 14 days before the first dose.
  • People who have previously been treated with medicines that target certain immune system checkpoint proteins (such as PD-1, PD-L1, or CTLA-4).
  • People with a current or past lung condition called interstitial lung disease (ILD) that required steroid treatment.
  • People with a history of certain lung conditions including idiopathic pulmonary fibrosis, drug-related lung inflammation, organising pneumonia, or unexplained lung inflammation, or who show signs of active lung inflammation on a recent chest scan.
  • People who have received a live vaccine within 28 days before the first dose.
  • People with certain serious health conditions that make chemotherapy and radiotherapy unsafe, including active infections, a heart attack within the past 6 months, certain heart conditions, or use of immunosuppressant medicines.
  • People who still have unresolved side effects rated as moderate or severe (Grade 2 or higher) from a previous treatment.
  • People who are pregnant or breastfeeding, or people who are capable of having children but are unwilling to use adequate contraception.
  • People with a known inherited condition affecting bleeding or blood clotting.
  • People with a prior history of another cancer (exceptions may apply for certain skin cancers, or early-stage breast, mouth, or cervical cancers where life expectancy is more than 3 years — confirm with trial site).

For people with extensive-stage small cell lung cancer (ES-SCLC):

  • People whose lung cancer is confirmed as a pulmonary carcinoid or non-small cell lung cancer, unless a transformation to small cell has been ruled out.
  • People with no recorded tumour assessment, or where that assessment data is missing.
  • People with a history of a serious allergic reaction to humanised antibody medicines or fusion protein medicines.
  • People currently experiencing a flare-up of chronic obstructive pulmonary disease (COPD) or another lung condition requiring hospital treatment.
  • People with a currently active autoimmune disease, or one that was active within the past 2 years, or a history of a primary immune deficiency condition.
  • People whose cancer got worse during or after immunotherapy treatment, or who have another active cancer (certain skin cancers or early-stage cervical cancer may be exceptions — confirm with trial site).
  • People with serious health conditions that make chemotherapy and radiotherapy unsafe, including active infections, a heart attack within the past 6 months, certain heart conditions, or use of immunosuppressant medicines.
  • People who still have unresolved side effects rated as moderate or severe (Grade 2 or higher) from a previous treatment.
  • People with a current or past autoimmune disease or immune deficiency condition, including conditions such as myasthenia gravis, muscle inflammation, autoimmune hepatitis, lupus, or rheumatoid arthritis.
  • People with a history of certain lung conditions including idiopathic pulmonary fibrosis, organising pneumonia, drug-related lung inflammation, or unexplained lung inflammation, or who show signs of active lung inflammation on a recent chest scan (people with scarring from past radiation to the lung may still be considered — confirm with trial site).
  • People who are pregnant or breastfeeding, or people who are capable of having children but are unwilling to use adequate contraception.

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 16 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 02122200000

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
Not Applicable
Sponsor
Shanghai Chest Hospital
Registry
ClinicalTrials.gov
Start date
1 April 2026
Est. completion
31 March 2029

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Progression-free survival (PFS); Overall Survival (OS)

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: 16 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