MDT-bridged Radical Therapy After Aumolertinib With MRD-guided Maintenance in EGFRm+ Unresectable… (NCT04841811) | Clinical Trial Compass
Active — Not RecruitingPhase 3
MDT-bridged Radical Therapy After Aumolertinib With MRD-guided Maintenance in EGFRm+ Unresectable Stage III NSCLC (APPROACH)
China192 participantsStarted 2022-06-20
Plain-language summary
This is an open-label, multi-center, randomized, phase III study. It is aimed to firstly evaluate the effectiveness and safety of almonertinib induction therapy in EGFR-mutated patients with unresectable stage III non-small cell lung cancer, and to evaluate the effectiveness and safety of dynamic MRD guided maintenance therapy with almonertinib after induction therapy with almonertinib and local therapy (radical surgery or radiotherapy) evaluated by MDT diagnostic model. The study includes a screening period (not more than 28 days after the subject with signed informed consent before first medication), treatment period (including induction therapy with almonertinib\\ radical therapy under MDT model\\ consolidation therapy with almonertinib) and follow-up period.
Who can participate
Age range
18 Years – 70 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
. Over 18 years old (including 18 years old) and under 70 years old (including 70 years old).
. The Eastern Cooperative Oncology Group (ECOG) physical status score is 0 or 1, and there is no deterioration within 2 weeks before the study drug treatment, and the expected survival period is not less than 12 weeks.
. Stage III non-squamous cell non-small cell lung cancer confirmed by histopathology or cytology and determined by the investigator to be unresectable (International Association for the Study of Lung Cancer Eighth Edition Lung Cancer Staging).
. Tumor tissue samples or blood samples, pleural effusions, ascites effusions, and pericardial effusions are confirmed to be EGFR sensitive mutations (ie, exon 19 deletion or L858R, alone or coexisting, Or with other EGFR mutations, but patients with EGFR20 exon insertion mutations cannot be included in the group) by laboratory tests approved by the investigator.
. According to the RECIST1.1 standard, the subject must have at least one imaging measurable lesion. The baseline tumor imaging evaluation was performed within 28 days before the first medication.
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
1
Assess the anti-tumor activity by IRC: ORR
Timeframe: 8 weeks
2
Assess the anti-tumor activity by IRC: Event free survival (EFS) rate
. Women of childbearing age should take appropriate contraceptive measures from screening to 3 months after stopping the study treatment and should not breastfeed. Before starting the administration, the pregnancy test is negative, or meeting one of the following criteria proves that there is no risk of pregnancy:
. Postmenopausal is defined as age greater than 50 years，and amenorrhea for at least 12 months after stopping all exogenous hormone replacement therapy.
. For women younger than 50 years old, if the amenorrhea is 12 months or more after stopping all exogenous hormone treatments, and the luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels are within the laboratory postmenopausal reference value range, also It can be considered postmenopausal.
Exclusion criteria
. Have received any of the following treatments:
. Have received lung surgery in the past;
. Have used any EGFR tyrosine kinase inhibitor in the past;
. Previously received any systemic chemotherapy or immunotherapy for lung cancer;
. Receive any lung cancer radiotherapy in the past;
. The patient has undergone open surgery on other parts except the lungs within 14 days before using the study drug for ≤14 days.
. In addition to NSCLC, another malignant disease has been diagnosed in the past 5 years (excluding completely resected basal cell carcinoma, bladder carcinoma in situ, and cervical carcinoma in situ).
. Have used proprietary Chinese medicines with anti-tumor effects in the past. Those who have used proprietary Chinese medicines with anti-tumor effects but have been used for no more than 7 days and have been stopped for 2 weeks or more before the drug treatment in this study can be included in the group.