Phase 3 Lung Cancer Trial, Recruiting NCT06437977 Sponsor: Shanghai Chest Hospital Condition: Lung Cancer
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Phase 3 Lung Cancer Trial, Recruiting

NCT06437977
Recruiting Phase 3

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, of any gender
  • People with a good general health and activity level (rated 0 or 1 on a standard performance scale used by doctors)
  • People who have been newly diagnosed with non-small cell lung cancer (NSCLC) that has been confirmed by a tissue biopsy, is considered surgically removable, and is classified as Stage II, IIIA, or IIIB (with a specific lymph node involvement called N2), and who have not yet received any treatment for it
  • People whose cancer can be measured on scans using standard medical criteria
  • People who can provide a tumour tissue sample before the trial begins, for testing including protein and gene marker analysis
  • People whose lung function is judged by their doctor to be adequate to withstand lung surgery
  • People whose tumour tissue testing has confirmed the absence of certain specific gene changes (EGFR and ALK sensitive mutations)
  • People with healthy enough bone marrow, liver, and kidney function, as confirmed by blood tests meeting specific minimum levels set by the trial
  • People who understand the study and are willing to sign a consent form
  • Women of childbearing age who have a negative pregnancy blood test within 3 days before the first dose

Who may not be able to join:

  • People whose cancer cannot be surgically removed, or has spread to other parts of the body, including those with certain advanced-stage disease features as defined by specific medical guidelines
  • People whose NSCLC is located in a specific area at the top of the lung (superior sulcus), or who have a large cell neuroendocrine cancer or sarcomatoid tumour type
  • People whose tumour testing shows certain specific gene changes (EGFR sensitive mutations or ALK translocation) — testing for these is required for people with non-squamous cell cancer types
  • People who have previously received any systemic cancer treatment for early-stage NSCLC, including experimental treatments
  • People who have a history of, or currently have, lung inflammation or scarring (pneumonitis or interstitial lung disease) that has required steroid medication
  • People with active tuberculosis
  • People with an active infection that requires treatment through the whole body (systemic treatment)
  • People with a known or suspected condition where the immune system attacks the body (autoimmune disorder) or a weakened immune system — with exceptions for well-controlled underactive thyroid or well-controlled Type 1 diabetes
  • People with uncontrolled active hepatitis B or active hepatitis C, based on specific blood test results (people with low hepatitis B levels who have been on antiviral treatment for at least 14 days and agree to continue may still be considered — confirm with trial site)
  • People known to have HIV infection
  • People who have received a live vaccine within 30 days before the first dose (examples include vaccines for mumps, rubella, measles, chickenpox, yellow fever, rabies, BCG, and live typhoid — inactivated vaccines are allowed)
  • People with moderate to severe nerve damage in the hands or feet (grade 2 or higher peripheral neuropathy)
  • People who have previously been treated with certain immune checkpoint drugs (PD-1/PD-L1 agents or similar drugs targeting T cell receptors such as CTLA-4 or OX-40)
  • People who have had a serious allergic reaction to other monoclonal antibody medications
  • People with a known serious allergy to any of the chemotherapy drugs used in this trial (pemetrexed, paclitaxel, docetaxel, cisplatin, or carboplatin) or their associated preventive medications
  • People with serious or uncontrolled existing health conditions, including certain heart or blood flow problems, recent stroke or other brain blood vessel events, or significant liver cirrhosis within the past 6 months
  • People whose health history, current conditions, or test results may interfere with the trial or would not be in their best interest, as assessed by the investigating doctors
  • People who have had another cancer within the past 5 years — with possible exceptions for certain low-risk cancers that have been fully treated (such as early-stage cervical, skin, or breast duct cancers), confirm with trial site

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 3: approximately ~65% 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

Principal Investigator: Xuwei Cai, Department of Radiation Oncology, Shanghai Chest Hospital, Shanghai, China

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
Phase 3
Sponsor
Shanghai Chest Hospital
Registry
ClinicalTrials.gov
Start date
12 September 2024
Est. completion
1 June 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

2-year Event Free Survival Rate; pCR rate

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