MDT-bridged Radical Therapy After Aumolertinib Introduction and Followed by MRD-guided Maintained… (NCT04841811) | Clinical Trial Compass
Active — Not RecruitingPhase 3
MDT-bridged Radical Therapy After Aumolertinib Introduction and Followed by MRD-guided Maintained Therapy for EGFR-mutated Unresectable Stage III NSCLC (APPROACH/CTONG2101)
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 range18 Years – 70 Years
SexALL
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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.
✓. 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:
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
. 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.