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Phase 2 Lung Cancer Trial, Not Yet Recruiting
NCT06936644
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 and able to sign a consent form and follow the study schedule and procedures.
- People who are male or female, aged 18 to 75 years old.
- People with an expected survival time of at least 6 months.
- People who have been diagnosed through tissue or cell testing with locally advanced (stage IIIB or IIIC), metastatic, or recurrent (stage IV) non-small cell lung cancer (NSCLC) that cannot be treated with surgery or a combination of chemotherapy and radiation therapy given at the same time.
- People whose cancer has been confirmed by a written test report to carry a specific gene change called KRAS G12C, and whose cancer does not carry certain other gene changes (such as EGFR or ALK mutations) that are approved for first-line NSCLC treatment by China's national medicines regulator (NMPA).
- People who have at least one tumour that can be measured using standard imaging criteria (RECIST 1.1).
- People who have not previously received any whole-body anti-cancer treatment for locally advanced or metastatic NSCLC; prior adjuvant (preventive) therapy is permitted, provided that at least 6 months passed between the end of that treatment (or the last radical radiotherapy) and the cancer coming back.
- People with a physical functioning score of 0 or 1 on the ECOG scale, meaning they are fully active or have only minor limitations on strenuous activity (confirm with trial site).
- People whose blood, liver, kidney, and clotting test results meet the required levels — including sufficient white blood cells, platelets, and haemoglobin; liver enzyme and bilirubin levels within acceptable ranges; kidney function within acceptable ranges and low urine protein; and normal clotting measures. Note: people who have received cell therapy or growth factor treatment within the 2 weeks before starting the study drug would not meet this criterion.
- Female participants of childbearing age and male participants whose partners are of childbearing age must use effective contraception throughout the treatment and for 180 days after treatment ends.
- Female participants must either have evidence of being post-menopausal or have a negative pregnancy test result before joining.
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 whose tumour tissue testing confirms the presence of small cell carcinoma, neuroendocrine carcinoma, sarcoma, lymphoepithelioma-like carcinoma, salivary gland tumours, or mesenchymal tumour components.
- People who have had significant heart or blood vessel problems, such as: a heart attack, angina, heart failure, serious irregular heartbeat, or procedures such as angioplasty, stent placement, or bypass surgery within the past 6 months; a clinically significant abnormal heart rhythm reading on an ECG (QTcF above 470ms for females or above 450ms for males); or a stroke or brain bleed within the past 3 months.
- People with active spread of cancer to the brain or the lining of the brain or spinal cord, unless specific conditions are met — for example, brain metastases that have been treated with radiotherapy or local treatment, are stable, and meet detailed symptom and medication requirements as assessed by the trial doctor (confirm with trial site).
- People who currently have significant lung conditions such as interstitial lung disease, radiation-related lung inflammation, drug-related lung inflammation, active tuberculosis, or dust-related lung disease; or who have grade 2 or higher pneumonia, or severely reduced lung function confirmed by breathing tests.
- People with significant digestive system problems, such as persistent hiccups, nausea, vomiting, severe stomach ulcers, liver cirrhosis, active gastrointestinal bleeding, or any condition that would affect the ability to swallow tablets or absorb oral medication properly.
- People with major active or chronic infections, including: infections currently needing whole-body treatment; a positive HIV antibody test; active hepatitis B or C meeting specific viral load criteria; or active tuberculosis.
- People with ongoing, recurring, or hard-to-treat fluid build-up around the lungs, abdomen, or heart.
- People with other poorly controlled ongoing conditions, such as high blood pressure (systolic at or above 150 mmHg or diastolic at or above 100 mmHg) or uncontrolled diabetes despite standard treatment.
- People with a history of significant bleeding problems or clotting disorders; or who have had notable bleeding episodes in the 4 weeks before joining (such as gastrointestinal bleeding, coughing up blood meeting specific criteria, or nosebleeds excluding minor ones); or whose scans show the tumour is close to major blood vessels or has areas of breakdown that the trial doctor considers a bleeding risk.
- People whose tumour is growing into or pressing on important nearby structures such as the aorta, heart, major veins, windpipe, or oesophagus, or where there is a risk of an abnormal opening forming between the oesophagus and airway or chest cavity; or where lymph node spread is pressing into the windpipe or main airways.
- People who have had another cancer in the 2 years before joining the study, except for certain early-stage or low-risk cancers that have been appropriately treated (such as cervical carcinoma in situ, certain skin cancers, prostate cancer not requiring treatment, early breast duct cancer, or superficial bladder cancer).
- People who have previously been treated with a KRAS G12C inhibitor.
- People who have previously received immunotherapy, including immune checkpoint inhibitors (such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 treatments), immune checkpoint activating drugs, or any other treatment targeting the immune system's response to the tumour.
- People who have previously received systemic treatment targeting the formation of new blood vessels in tumours, including drugs such as bevacizumab and similar medicines, endostar, certain targeted oral therapies, or ramucirumab.
- People who have received certain traditional Chinese medicines with anti-tumour indications within 1 week before the first dose, or drugs with immune-modifying effects within 2 weeks before the first dose (excluding local use for fluid control around the lungs).
- People who have received radiotherapy (other than to the brain) or local tumour treatments within 14 days before the first dose.
- People who have received chemotherapy, targeted therapy, immunotherapy, other experimental drugs or devices, or other anti-tumour treatments within 28 days or 5 half-lives of that treatment (whichever is shorter) before the first dose.
- People who have had surgery that could affect how the study treatment is given or assessed within 28 days before joining (excluding biopsy procedures).
- People who have taken certain specific medications that interact with key drug-processing pathways (CYP2D6, CYP3A4, P-gp, and BCRP) within 14 days or 5 half-lives before the first dose, where those medications have a narrow safe dosing range — unless the trial doctor and sponsor agree to an exception (confirm with trial site).
- People who are currently taking part in another interventional clinical trial, except for observational studies or follow-up phases of a completed trial.
- People who have used immune-suppressing drugs within 4 weeks before the first dose, with some exceptions such as low-dose steroids by nasal spray, inhaler, or other local routes, low-dose systemic steroids at standard replacement levels, or steroids used to prevent reactions to contrast dyes.
- People who have received a live attenuated vaccine within 4 weeks before the first dose, or who plan to receive one during the study. Note: injected inactivated influenza vaccines are permitted, but live attenuated influenza vaccines are not.
- People with a known or suspected autoimmune disease, or a history of one in the past 2 years — though some conditions may be acceptable, such as vitiligo, psoriasis, hair loss, or Graves' disease not requiring systemic treatment in the past 2 years, thyroid underactivity treated only with hormone replacement, or type 1 diabetes treated only with insulin (confirm with trial site).
- People with active or confirmed past inflammatory bowel disease, such as Crohn's disease, ulcerative colitis, or chronic diarrhoea.
- People with a known history of a primary immune deficiency condition.
- People with a known history of receiving a donated organ transplant or donated stem cell transplant.
- People who have had a deep vein clot, pulmonary embolism, or other serious blood clot event in the 3 months before joining (note: clots related to implanted ports or catheters, or superficial vein clots, are not considered serious for this criterion).
- People with a known allergy to the study treatment or any of its ingredients.
- Women who are pregnant or breastfeeding.
- People whom the trial investigator considers unsuitable for participation 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: +86 021-62821990
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 Chest Hospital
Registry
ClinicalTrials.gov
Start date
30 April 2025
Est. completion
30 April 2027
Primary endpoints
ORR
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.