Treatment of EGFR-TKI for Residual Lesions of Multiple Synchronous Ground-glass Opacities (NCT04982900) | Clinical Trial Compass
UnknownPhase 2
Treatment of EGFR-TKI for Residual Lesions of Multiple Synchronous Ground-glass Opacities
China138 participantsStarted 2021-10-01
Plain-language summary
This study is a multi-center, prospective, double-blind randomized controlled clinical trial. The purpose is to evaluate the efficacy and safety of EGFR-TKI on residual GGOs after surgery in patients with multiple primary lung cancers with ground glass nodules. This study is expected to prove that compared with placebo in the control group, EGFR-TKI can significantly reduce the residual GGOs lesions in patients with EGFR-positive multiple primary lung cancers with ground-glass opacity, and bring a higher objective response rate (ORR), thus provides new insights for treatment of these patients.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. The patient was diagnosed with MPLC (based on the previously published MM/ACCP clinical criteria). The preoperative chest CT scan (1mm slice thickness) found two or more ground glass lesions (≥6mm and \<3 cm, pure ground glass or partial solid) that could not be operated at the same time;
* 2\. The patient has received surgery to remove the main lesion. The pathology of the main lesion is NSCLC with sensitizing EGFR mutation positive (19del/L858R), with or without other EGFR mutations including T790M;
* 3\. After resection of the main lesion, the patient should have at least one residual ground glass nodules (≥6mm and \<3 cm) that are suspected of being malignant and cannot be resected simultaneously with main lesion. The malignancy has been confirmed by both qualified radiologist and thoracic surgeon;
* 4\. The included MPLC patients' clinical staging from preoperative evaluation should be cTis-T1c, N0, M0 (according to NCCN/EEJC 2021 V1);
* 5\. Patients' ECOG PS score 0-1;
* 6\. The subject voluntarily participates in the study and has signed a written informed consent form.
Exclusion Criteria:
* 1\. MPLC with lymph node metastasis, unresectable disease or distant metastasis, including pleural and pericardial metastasis;
* 2\. Those who have severe cardiac, pulmonary, hepatic, and renal failure and cannot tolerate surgery;
* 3\. Patients suffering from other malignant tumors or a history of other malignant tumors within 5 years; except effective…