Not Yet RecruitingPhase 2

A Prospective Study of Firmonertinib as First-line Adaptive Therapy Guided by Dynamic ctDNA (MRD) Changes in Locally Advanced or Metastatic EGFR-mutated Non-small Cell Lung Cancer

China154 participantsStarted 2026-06-06

Plain-language summary

Exploring the efficacy and safety of adaptively adjusting treatment regimens based on ctDNA (MRD) status for EGFR mutation-positive NSCLC

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Absolute neutrophil count (ANC) ≥1.5x10\^9/L without the use of granulocyte colony-stimulating factor in the past 14 days;
. Platelets ≥100×10\^9/L without blood transfusion in the past 14 days;
. Hemoglobin \>9g/dL without blood transfusion or erythropoietin use in the past 14 days;
. Total bilirubin ≤1.5×upper limit of normal (ULN);
. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN (subjects with liver metastasis are allowed to have ALT or AST ≤5×ULN);
. Serum creatinine ≤1.5×ULN and creatinine clearance rate (calculated using the Cockcroft-Gault formula) ≥60 ml/min;
. Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN;
. Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range may also be enrolled;

Exclusion criteria

. received systemic anti-tumor therapy within 3 weeks before treatment, such as chemotherapy, targeted therapy, immunotherapy (including Chinese herbal medicine therapy with anti-tumor indications), etc.;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Progression-free survival (PFS)

Timeframe: through study completion, an average of 2 years

Trial details

NCT IDNCT07661173

SponsorAnhui Provincial Cancer Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-03-06

Contact for this trial

Yueyin Pan

13805695536 panyueyin@ustc.edu.cn

View on ClinicalTrials.gov More Non Small Cell Lung Cancer trials