Adjuvant Target Therapy Guided by ctDNA-MRD in Patients With EGFR-mutant II-IIIA Non-small Cell Lung Cancer (ECTOP-1022)

Launched by FUDAN UNIVERSITY · Mar 14, 2024

Keywords

ClinConnect Summary

The ECTOP-1022 clinical trial is studying the best ways to treat patients with a specific type of lung cancer called non-small cell lung cancer (NSCLC) that has a mutation in the EGFR gene. This trial focuses on patients who have had surgery to remove their cancer and are at stages II to IIIA. Researchers will test a blood sample for ctDNA, which helps identify tiny amounts of cancer DNA that might remain after surgery. If the test shows positive ctDNA, patients will receive standard treatment. If the test is negative, they will be closely monitored without immediate treatment. The study will then randomly assign patients to either continue observation or receive a medication called osimertinib, to see which approach works better for their recovery.

To participate in this trial, patients need to be over 18 years old, have a confirmed diagnosis of stage II-IIIA NSCLC with an EGFR mutation, and should have undergone complete surgical removal of the cancer. Patients must also be in good health overall, meaning they shouldn't have serious other health issues. The trial aims to provide clearer guidance on treatment options for patients with this type of lung cancer, helping doctors make better decisions for their care. If you're interested in joining or learning more, it's important to discuss it with your healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age greater than 18 years old, both males and females are eligible.
• • 2. Histologically confirmed diagnosis of non-small cell lung cancer.
• • 3. Diagnosis of stage II-IIIA (N1-N2) non-small cell lung cancer based on the 8th edition TNM staging guidelines combined with radiological evaluation.
• • 4. EGFR mutation-positive status confirmed through molecular testing (such as ARMS-PCR or high-throughput sequencing), specifically with mutations 19del or 21L858R.
• • 5. Able to undergo R0 surgical resection.
• • 6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1. Expected survival of more than 12 months.
• 7. Baseline blood routine and biochemical indicators meeting the following criteria:
• • Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L;
• • Lymphocyte count ≥ 0.5 × 10\^9/L;
• • Platelet count ≥ 100 × 10\^9/L;
• • Hemoglobin ≥ 9 g/dL.
• • Total bilirubin ≤ 1.5 times the upper limit of normal (ULN);
• • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 times ULN.
• • 8. Patients must provide informed consent, either directly or through their legally authorized representatives, after being informed about the study.
• Exclusion Criteria:
• • 1. Pathological diagnosis of mixed-type lung cancer (including a history of small cell lung cancer or non-adenocarcinoma).
• • 2. Received anti-tumor therapy before surgery (including radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.).
• • 3. Rx, R1, R2 surgical resection.
• • 4. Received blood transfusion during surgery or within 2 weeks before surgery.
• • 5. Pregnant or lactating female patients.
• • 6. History of other malignant tumors within the past 5 years, except for cases where other malignant tumors have been cured solely through surgery with a disease-free interval of at least 10 years, curable basal cell carcinoma of the skin, and cervical carcinoma in situ.
• • 7. Any unstable systemic diseases (including active infections, uncontrolled hypertension, unstable angina pectoris, congestive heart failure, myocardial infarction within the past year, severe arrhythmias requiring medication, liver, kidney, or metabolic diseases).
• • 8. Evidence of any other diseases, neurological or metabolic functional disorders, physical examination findings, or laboratory findings that would place the subject at high risk of treatment-related complications.
• • 9. Other factors deemed by the investigators to potentially affect the study process.