Printed from Voxsanity (voxsanity.com.au) — NCT06644313 — 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
NCT06644313
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
- Patients who have signed the informed consent form, are aged 18 or older, and have a confirmed diagnosis of non-small cell lung cancer (NSCLC) through a tissue or cell sample, assessed by researchers as stage III to IVA.
- Patients whose genetic testing (NGS) has confirmed a specific MET gene change — either a MET exon 14 skipping mutation (Cohort 1) or a primary MET gene amplification (Cohort 2) — from a certified laboratory.
- Patients with a general health/activity level rated as 0 or 1 on a standard medical scale, meaning they are fully active or have only minor limitations in physical activity.
- Patients whose cancer has been assessed by a specialist medical team (including a thoracic surgeon) as potentially able to be completely removed by surgery.
- Patients who have at least one measurable tumour lesion as defined by standard imaging criteria.
- Patients whose liver, kidneys, blood system, and other major organs are functioning well.
- Patients whose lung function is considered sufficient to tolerate surgery.
- Female patients who are capable of becoming pregnant must agree to use effective contraception throughout the study and for at least 120 days after chemotherapy or the last dose of the study drug toripalimab (whichever is later), and must have a negative pregnancy test within 7 days before joining.
- Male patients who have not been sterilised must agree to use effective contraception throughout the study for at least 120 days (confirm with trial site for full details).
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.
- Patients who have previously received targeted therapy (including TKI or monoclonal antibody treatments), immunotherapy, or any experimental drug treatment for NSCLC.
- Patients whose cancer has been confirmed to be a mix of small cell and non-small cell lung cancer.
- Patients who have had another cancer within the five years before the trial starts, with exceptions for certain treated or low-risk cancers such as cured skin basal cell carcinoma, early gastrointestinal cancer removed by endoscopy, cervical carcinoma in situ, breast ductal carcinoma in situ, papillary thyroid carcinoma, or any cured cancer considered to have no impact on the current NSCLC.
- Patients with any unstable ongoing illness, including active infection, uncontrolled high blood pressure, unstable or recent-onset chest pain (angina), heart failure of a certain severity, a heart attack in the past six months, serious heart rhythm problems requiring medication, or significant liver, kidney, or metabolic disease.
- Patients with a known immune system deficiency, whether from birth or acquired (for example, those with HIV).
- Patients who have had a major surgical procedure (other than for diagnosis) within 4 weeks before the trial starts, or who are expected to need major surgery during the trial.
- Patients who have a known allergy to the study drug or any of its ingredients.
- Patients with a history of extensive, widespread lung scarring (bilateral interstitial fibrosis) or a known history of grade 3 or 4 interstitial lung disease — including certain types of lung inflammation or fibrosis — except for localised radiation-related lung changes.
- Women who are pregnant or currently breastfeeding.
- Patients who have conditions that prevent proper absorption of medications through the digestive system.
- Patients with neurological or psychiatric conditions that would prevent them from participating in the trial.
- Patients who the researchers consider unsuitable for enrolment for any other reason.
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: 021-65115006
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
Not Yet Recruiting
Phase
Phase 2
Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Registry
ClinicalTrials.gov
Start date
1 November 2024
Est. completion
1 November 2029
Primary endpoints
Objective response (ORR) rate
Can't join this trial?
Data last synced from ClinicalTrials.gov: 9 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.