Phase 2 Lung Cancer Trial, Recruiting NCT07559786 Sponsor: Henan Cancer Hospital Condition: Lung Cancer
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Phase 2 Lung Cancer Trial, Recruiting

NCT07559786
Recruiting Phase 2

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not 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 may be able to join

  • People aged 18 to 75 years, of any gender.
  • People who have been diagnosed with limited-stage small cell lung cancer (a specific early-to-middle stage of lung cancer, stages I–III) confirmed by a tissue test, who have not yet received any treatment, and whose cancer can be fully covered by a radiation treatment plan.
  • People whose cancer is at an early clinical stage (T1–2, N0) where surgery could be an option but is either not recommended for them or has been refused by them.
  • People who are largely able to care for themselves and carry out light activity (a standard fitness measure called ECOG performance status of 0 or 1).
  • People with an expected survival of at least 3 months.
  • People who have at least one tumour that can be measured by standard imaging criteria (called RECIST 1.1).
  • People whose lungs are functioning reasonably well, with a breathing test result (FEV1) above 70% of what is expected for their age and size.
  • People whose blood counts are at acceptable levels within 7 days before starting the study, without recent support from blood-boosting medications: sufficient white blood cells (neutrophils ≥ 1.5×10⁹/L), lymphocytes (≥ 0.5×10⁹/L), and platelets (≥ 90×10⁹/L).
  • People whose liver enzyme levels (AST and ALT) are no more than 3 times the upper limit of normal, and whose total bilirubin is within acceptable limits (with a slightly higher allowance for people with a condition called Gilbert syndrome).
  • People whose kidney function is within acceptable limits, based on blood or urine tests (confirm specific values with the trial site).
  • People whose blood clotting test results (INR and APTT) are within acceptable ranges.
  • People whose heart pumping function (left ventricular ejection fraction) is at least 50%, confirmed by a heart ultrasound.
  • People who are sexually active and capable of having children must agree to use at least one medically accepted form of contraception during the study and for 3 months after treatment ends; women who could become pregnant must have a negative pregnancy blood test within 7 days before starting treatment.
  • People who are willing to join voluntarily, sign a written consent form, are able to follow the study requirements, and agree to attend follow-up appointments.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People whose lung cancer is confirmed by tissue testing to be a combined type of small cell and non-small cell lung cancer.
  • People who have already received any systemic cancer treatment or immune checkpoint therapy for their small cell lung cancer.
  • People whose small cell lung cancer is classified as extensive-stage (meaning it has spread widely).
  • People who have cancerous fluid around their lungs (malignant pleural effusion); if fluid is present and can be drained, at least one drainage procedure must be done to check whether cancer cells are present.
  • People with known or suspected scarring or inflammation of the lung tissue (interstitial lung disease), or other moderate-to-severe lung conditions that could interfere with identifying or managing drug-related lung side effects — such as idiopathic pulmonary fibrosis or organising pneumonia.
  • People with a history of active autoimmune diseases (conditions where the immune system attacks the body), such as myasthenia gravis, autoimmune hepatitis, lupus, rheumatoid arthritis, or inflammatory bowel disease — with some exceptions for well-controlled or stable conditions (confirm exceptions with the trial site).
  • People with certain skin conditions such as eczema, psoriasis, or vitiligo may be excluded unless specific conditions are met regarding how much of the body is affected, how well the condition is controlled, and what treatments have been used (confirm with trial site).
  • People who have been diagnosed with another cancer within the past 3 years, with some exceptions for certain fully treated cancers such as thyroid, skin, cervical, prostate, or breast cancers (confirm specific exceptions with the trial site).
  • People with a significant history of heart disease, including heart failure, unstable chest pain (angina), a heart attack within the past 3 months, or serious irregular heartbeats requiring treatment.
  • People who had a serious infection in the 4 weeks before starting treatment, or an active infection requiring antibiotics within the 2 weeks before starting treatment.
  • People with active tuberculosis within the past year, or a history of tuberculosis that was not properly treated.
  • People with a weakened immune system, including those who test positive for HIV.
  • People with active hepatitis B or hepatitis C — though people with certain hepatitis B or C markers may still be eligible if virus levels in the blood are below specific limits (confirm with trial site).
  • People who have received immune-suppressing medications (such as steroids or certain other drugs) within 14 days before starting treatment, with some exceptions for short-term use, inhaled steroids, or very low-dose replacement steroids (confirm exceptions with trial site).
  • People who have had major surgery within 28 days before starting treatment (not including minor diagnostic procedures), or who are expected to need major surgery during the study.
  • People who have received a live attenuated vaccine (a type of vaccine using a weakened live virus) within 28 days before starting treatment, or who are expected to need one during the study; a specific flu vaccine of this type is also not permitted during treatment or for 5 months after the last dose of the study drug.
  • People who have previously received a bone marrow transplant from a donor, or a transplanted organ from another person.
  • People with a history of severe allergic reactions to monoclonal antibody or fusion protein medicines.
  • People with known serious psychiatric conditions, alcoholism, or drug or substance misuse.
  • People who, in the treating doctor's judgement, have other conditions that could affect their safety or their ability to complete the study, such as other serious illnesses, significant abnormal test results, or social or family circumstances that could affect their wellbeing or the collection of study data.

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

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Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Henan Cancer Hospital
Registry
ClinicalTrials.gov
Start date
1 April 2026
Est. completion
1 April 2029

Where this trial is recruiting

🇨🇳 China

Primary endpoints

PFS

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