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Phase 2 Lung Cancer Trial, Not Yet Recruiting
NCT07554859
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 willing to take part and have signed the official consent form agreeing to participate.
- People who are male or female, aged between 18 and 75 years old at the time of signing the consent form.
- People who have been confirmed through laboratory testing (from tissue or cell samples) to have advanced (Stage IV) or locally advanced non-squamous non-small cell lung cancer that cannot be treated with surgery or radiotherapy aimed at curing the disease.
- People who have a written test result confirming a specific genetic change in their cancer called a KRAS G12D mutation.
- People who are able to provide a stored tumour tissue sample in a specific laboratory format, or who are able to have a new tumour biopsy taken before treatment begins.
- People who have not had any previous systemic (whole-body) treatment for their advanced cancer, or who are not eligible for standard treatment options, or who — in the treating doctor's judgement — may benefit more from the trial drug (GFH375, alone or in combination) than from available standard treatments.
- People who have at least one measurable tumour outside the brain and spinal cord area, as defined by standard measurement guidelines (RECIST v1.1); tumours previously treated with local radiotherapy can only count as measurable if they have clearly grown since that radiotherapy.
- People whose general health and ability to carry out daily activities is rated as 0 or 1 on a standard medical scale (ECOG performance status), meaning they are either fully active or have only minor limitations.
- People who are expected to live for at least 3 months, based on the treating doctor's assessment.
- People whose liver, kidneys, blood, and other organs are functioning at an adequate level (confirm with trial site for specific thresholds).
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 had another serious (invasive) cancer that was still progressing or needed treatment within the 3 years before joining, with some exceptions such as certain treated skin cancers, early-stage bladder cancer, cervical carcinoma in situ, early breast ductal carcinoma in situ, or papillary thyroid carcinoma.
- People whose lung cancer has been confirmed through testing to be a specific type, including squamous cell lung cancer, adenosquamous carcinoma, neuroendocrine carcinoma (including small cell lung cancer and large cell neuroendocrine carcinoma), or mixed small cell lung cancer.
- People whose cancer is known to have other specific genetic changes (driver gene alterations) that can be targeted by existing treatments.
- People who have active or symptomatic cancer spread to the brain, the lining of the brain or spinal cord, or who have compression of the spinal cord.
- People who have clinically significant serious heart or blood vessel disease.
- People who have had a stroke or other serious brain blood vessel event in the 6 months before joining the trial.
- People who have had a deep vein blood clot or other serious blood clot condition in the 3 months before joining.
- People who have fluid build-up around the lungs, in the abdomen, or around the heart that needs to be drained frequently (2 or more times per month) or that is causing moderate to severe symptoms.
- People who have significant lung inflammation (interstitial lung disease, radiation pneumonitis, or immune-related pneumonitis) that requires medical treatment.
- People who are at high risk of bleeding or a tear (perforation) in the stomach or bowel.
- People who have a blockage at the stomach outlet, frequent or repeated vomiting (3 or more episodes within 24 hours), are unable or unwilling to swallow tablets, or have other significant stomach or bowel conditions that could affect how the trial drug is absorbed.
- People who have a history of ongoing (chronic) diarrhoea.
- People who have a major ongoing or long-term infectious disease.
- People who have other serious medical conditions that are not well controlled.
- People for whom the treating doctor has planned a major surgical procedure.
- People who have previously had an organ transplant or who are planning to have one (except for corneal transplants).
- People who are known to be allergic to the trial drug or any of its ingredients.
- People who have received or are planned to receive a live attenuated vaccine (a type of vaccine made from a weakened live virus or bacteria) within 28 days before joining or during the trial treatment period.
- People who have severe mental health or psychological conditions, a history of substance misuse, or a history of severe alcohol dependence.
- Women who are pregnant or currently breastfeeding.
- People who have other conditions that the treating doctor considers make participation in this trial unsuitable.
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
Principal Investigator: Yilong Wu, Guangdong Provincial People's Hospital
Phone: +8618073129952
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
Genfleet Therapeutics (Shanghai) Inc.
Registry
ClinicalTrials.gov
Start date
20 May 2026
Est. completion
30 April 2027
Where this trial is recruiting
🇨🇳 China
Primary endpoints
the efficacy of GFH375 as monotherapy and in combination therapy
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 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.