Multiple Primary Lung Cancers Clinical Trial
Official title:
A Prospective, Multi-center, Double-blind Randomized Controlled Clinical Trial on the Treatment of EGFR-TKI for Residual Lesions of Multiple Synchronous Ground-glass Opacities
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.
Lung cancer is one of the most deadly malignant tumors in the world. It is estimated that 0.2-20% of lung cancer patients have multiple primary lung cancers at the time of diagnosis, and many of them present with multiple ground glass opacities. The surgical method for such multiple lesions depends on their number, anatomical location and size, as well as the age and pulmonary function of the patient. It is easily affected by the subjective judgment of the surgeon. Besides, many of these patients develop multiple lesions that cannot be resected at the same time, and there haven't been established a standard therapy for residual GGO lesions after surgery. According to the National Comprehensive Cancer Network (NCCN) guidelines, EGFR-TKI is recommended for the adjuvant treatment of stage IB-ⅢA NSCLC with EGFR mutations. However, it is not clear whether EGFR-TKI is effective for multiple primary lung cancers or the residual GGOs after surgical resection of the EGFR mutation positive main cancers. At present, there have been retrospective studies showing that application of EGFR-TKIs targeted therapy can significantly reduce the diameter of residual GGOs after surgery resection of EGFR mutation-positive primary lesions for MPLC patients, and reduce the secondary surgery caused by the progression of the lesion. However, there is no prospective Studies confirming the efficacy and safety of EGFR-TKI on these postoperative residual GGOs lesions. This study is a multi-center, prospective, double-blind, comparative clinical research. This study plans to enroll 138 patients with multiple primary lung cancers (cTis-T1c, N0, M0) that manifest GGO and cannot be resected at the same time, patients should have undergone surgical resection of the EGFR mutated main lesion, and have no less than 1 GGO lesion remaining after surgery. Eligible patients will be randomly divided into the treatment group (receiving furmonertinib mesilate tablets) or control group (placebo) at a ratio of 1:1. The grouping process was strictly double-blind for both the investigators and subjects. By collecting the relevant data of patients' baseline images, pathology, and follow-up images during treatment, statistical analysis is used to evaluate the effectiveness (response rate, objective remission rate), safety, and relevant influencing factors (including CTR value of the main lesion, number of residual lesions, diameter of the largest residual lesion, higher stage of the main lesion, residual lesion's density, etc.) of EGFR-TKI treatment. This study is expected to prove that compared with the placebo in the control group, EGFR-TKI can significantly reduce the diameter of residual GGO lesions in patients with EGFR-positive multiple primary lung cancers with ground-glass density, and bring a higher objective response rate (ORR) but did not significantly increase the incidence of adverse effects. ;
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