Printed from Voxsanity (voxsanity.com.au) — NCT06525350 — 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
NCT06525350
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 who are able to understand and voluntarily sign a written consent form.
- People aged 18 years or older, of any gender.
- People diagnosed with non-small cell lung cancer that cannot be surgically removed and has either spread to nearby areas or to other parts of the body (stage IIIB, IIIC, or IV), confirmed by laboratory testing of tissue or cell samples.
- People who are able to provide a tumor tissue sample that meets the central laboratory's testing requirements, or who agree to have a tumor biopsy taken, so the laboratory can test for MET protein levels and gene changes.
- People whose tumor tissue has been confirmed by the sponsor's central laboratory to show high levels of MET protein expression.
- People whose tumor does not have certain known genetic changes that drive cancer growth (such as EGFR mutations, ALK fusion, ROS1 rearrangement, BRAF V600 mutation, NTRK fusion, MET exon 14 skipping, RET rearrangement, HER2 mutations, KRAS mutations, and others).
- People who have previously been treated with immunotherapy drugs that target PD-1 or PD-L1, as well as platinum-based chemotherapy (given together or one after the other).
- People who have at least one area of cancer that can be measured on scans, based on standard measurement guidelines (RECIST 1.1).
- People with a performance score of 0 or 1 on the ECOG scale, meaning they are fully active or have only minor limitations in physical activity.
- People with an expected survival of at least 3 months.
- People with adequate organ and bone marrow function within 7 days before starting the trial treatment.
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 who have previously received any treatment specifically targeting the MET protein.
- People whose previous treatment included the chemotherapy drug docetaxel.
- People who have cancer that has spread to the lining of the brain, is pressing on the spinal cord, or has spread to the brain and has not yet been treated.
- People whose scans show that the tumor is located near major blood vessels in a way that the treating doctor has determined poses a risk of serious, life-threatening bleeding.
- People with a type of lung cancer (central squamous cell lung cancer) that has developed cavities or involves coughing up significant amounts of blood (more than 50 mL per day).
- People who, within 14 days before starting the trial, have an uncontrolled build-up of fluid in a body cavity that requires frequent draining or ongoing medical management.
- People whose side effects from previous cancer treatments (including radiotherapy) have not improved to a mild or baseline level before joining the trial (with some exceptions, such as hair loss or fatigue, as assessed by the treating doctor).
- People who have had another type of cancer in the past 5 years, with the exception of certain localised cancers that have already been treated (such as some skin cancers, early-stage bladder cancer, or certain in-situ cancers of the cervix, prostate, or breast).
- People who have received any systemic cancer treatment — including chemotherapy, targeted therapy, biological therapy, immunotherapy, immune-modulating drugs, or other experimental drugs — within 28 days or 5 half-lives before starting the trial (whichever is the shorter period).
- People who have had radiation therapy to the chest area within 28 days before starting the trial, or radiation therapy to any other area of the body within 14 days before starting the trial.
- People who have used Chinese herbal medicines or traditional Chinese patent medicines for cancer control within 14 days before starting the trial.
- People who have taken strong CYP3A4 inhibitor or inducer medications within 14 days before starting the trial, or who cannot stop taking strong CYP3A4 inhibitors during the study (confirm with trial site).
- People who have had major surgery (not including biopsies) or serious physical injury within 28 days before starting the trial, or who are expected to need major surgery during the study.
- People who, within 6 months before starting the trial, have had a history of a hole or abnormal passage in the gastrointestinal tract, serious stomach or bowel ulcers or surgery, impaired gut function, or other conditions that may affect how the trial drug is absorbed.
- People who have grade 2 or higher swelling from fluid build-up (oedema or lymphoedema) that cannot be managed with treatment.
- People who have received a live or weakened live vaccine within 28 days before starting the trial, or who plan to receive one during the study.
- People who, within 14 days before starting the trial, required systemic antibiotics, antifungal, or antiviral medicines for serious or active infections (including tuberculosis).
- People who have had serious or uncontrolled heart or blood vessel conditions requiring treatment in the 6 months before screening.
- People who have interstitial lung disease, drug-related lung inflammation, non-infectious pneumonia (including radiation-related pneumonia), lung scarring (pulmonary fibrosis), or acute lung disease that requires steroid treatment.
- People with a history of a weakened immune system, including HIV infection, AIDS, other immune deficiency conditions, or a history of organ transplant.
- People with active hepatitis B, active hepatitis C, active syphilis, or active tuberculosis.
- People with a history of autoimmune disease.
- People with a history of other serious illnesses (confirm with trial site for specifics).
- People known to have allergies or hypersensitivity reactions to any of the trial drugs or their ingredients, or who have a history of other serious allergic reactions.
- People who are pregnant or breastfeeding, or women of childbearing potential whose pregnancy test (taken within 7 days before enrolling) is positive.
- People of any gender who are able to have children and who are unwilling to use highly effective contraception throughout the entire trial period and for 6 months after the last dose.
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: 86-0311-69085587
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
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Registry
ClinicalTrials.gov
Start date
1 July 2024
Est. completion
25 December 2026
Primary endpoints
Dose-limiting toxicity(DLT) occurrence and incidence; Recommended phase 2 dose(RP2D) of the combination therapy; Adverse events (AE) and serious adverse events (SAE) occurrence and incidence; Objective response rate (ORR) per RECIST 1.1
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 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.