Printed from Voxsanity (voxsanity.com.au) — NCT06780839 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Lung Cancer Trial, Not Yet Recruiting
NCT06780839
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
- The person has been diagnosed with primary non-small cell lung cancer (a type of lung cancer), confirmed by laboratory tissue testing.
- The person is 18 years of age or older; any gender is eligible.
- The person has had their lung cancer staged according to a specific international staging system (AJCC/UICC 8th edition), and had complete surgical removal of the cancer at stage IA3 with high-risk features, IB, II, IIIA, or a specific type of IIIB (T3N2M0 only), confirmed by pathology.
- The person has fully recovered from their surgery.
- Tumour tissue tested at a local laboratory shows a positive ALK result (a specific genetic marker), accepted through one of several approved testing methods (IHC, RT-PCR, FISH, or NGS).
- The person is intended to receive a drug called enshatinib as a treatment after surgery.
- The person has an ECOG physical status score of 0 or 1, meaning they are generally active and able to carry out daily activities (confirm with trial site).
- The person has good blood cell counts and organ function, meeting required laboratory values.
- People with active hepatitis B or hepatitis C may be eligible, provided they are receiving appropriate antiviral treatment beforehand and their liver function meets the required level.
- People with a positive syphilis test may be eligible, provided they receive appropriate anti-syphilis treatment beforehand and do not have serious complications such as syphilitic heart disease.
- People who could become pregnant must have a negative blood pregnancy test at screening and at the end of the study; people whose partners could become pregnant must either have had a sterilisation procedure or use effective contraception during and after the study period.
- The person has given their informed consent voluntarily and is willing and able to follow the trial procedures and 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.
- The person is currently participating in another clinical trial and receiving an investigational drug or device within 4 weeks before the first dose (participation in non-interventional trials may be acceptable — confirm with trial site).
- There is cancer that could not be fully removed by surgery, the pathology report shows cancer cells at the surgical margin, or there is cancer spread beyond the lymph node capsule.
- The person has had another type of cancer in the 5 years before the first dose, except for certain cancers considered fully treated and cured (such as treated thyroid cancer, cervical carcinoma in situ, certain skin cancers, or breast ductal carcinoma in situ treated with surgery).
- The person has previously received treatment for non-small cell lung cancer, including chemotherapy (more than 2 cycles before surgery), targeted therapy, immunotherapy, or other investigational therapies.
- The person has had major surgery within 3 weeks before the first dose (this includes the lung tumour surgery itself, open chest surgery, or open abdominal surgery, but does not include procedures to place a vascular access device).
- The person has used traditional Chinese medicine or herbal preparations intended to treat or support cancer treatment within 14 days before the first dose.
- The person has taken certain medications that strongly affect how the body processes drugs (strong CYP3A inhibitors, inducers, or narrow therapeutic index CYP3A substrates) within 14 days before the first dose (confirm with trial site).
- The person has clinically significant heart or blood vessel disease.
- The person has a serious active infection, interstitial lung disease or pneumonia, or another serious underlying health condition within 2 weeks before the first dose that may affect their ability to receive treatment.
- The person has tested positive for HIV antibodies.
- The person has active tuberculosis of the lungs.
- The person is pregnant or currently breastfeeding.
- The person has any other significant medical condition or circumstance that the trial investigator considers makes participation unsuitable or may affect the person's ability to follow the trial requirements or provide informed consent.
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.
Contact this trial
Phone: +86-010-88196391
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Peking University Cancer Hospital & Institute
Registry
ClinicalTrials.gov
Start date
15 January 2025
Est. completion
15 January 2029
Where this trial is recruiting
🇨🇳 China
Primary endpoints
DFS
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 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.