Neoplasms

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Carcinoma, Non-Small-Cell Lung

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ectinib 125mg/ tablet, one tablet at a time, three times a day, take orally;Pemetrexed 500mg/m2, intravenous infusion, day 1;Carboplatin AUC6/ Cisplatin 75mg/m2,intravenous infusion, day 1,21 days for a cycle, a total of 6 cycles.Maintenance therapy: ectinib: ectinib 125mg/ tablet, one tablet at a time, three times a day, take orally, pemetrexed 500mg/m2,d intravenous infusion, day 1,21 days for a cycle

Intervention: Drug: Icotinib Ectinib 125mg/ tablet, one tablet at a time, three times a day, take orally

Intervention: Drug: Carboplatin/ Cisplatin Pemetrexed 500mg/m2, intravenous infusion, day 1;Carboplatin AUC6/ Cisplatin 75mg/m2,intravenous infusion, day 1,21 days for a cycle

Icotinib

Peng Chen, M.D.

This single-arm, open, multicenter clinical study is going to evaluate the efficacy and safety of combination therapy with ectiecinib, pemetrexed and platinum in patients with metastatic non-squamous non-small cell lung cancer with EGFR mutations who did not progress after pemetrexed in combination with platinum-based chemotherapy.

The positive rate of EGFR mutations in lung adenocarcinoma patients is about 50% in both Asian population and China.Domestic and international clinical studies have found that targeted therapy combination chemotherapy can prolong the overall survival of patients with EGFR mutations, and a large number of class 2A evidences have been recommended.The 2018 CSCO lung cancer guidelines recommend EGFR-TKIs combined with chemotherapy for first-line treatment of advanced EGFR mutant NSCLC (grade II recommended).The independently developed ectinib in China, belong to EGFR-TKIs as gefitinib and erlotinib . The results of phase III clinical trial (ICOGEN) showed that the efficacy of ectinib and gefitinib was similar, but in terms of safety, the adverse reactions of the ectinib group were significantly lower than that of the gefitinib group, and the difference between the two groups was statistically significant.Targeted combination chemotherapy has relatively large side effects, which will increase chemotherapy-related side effects, mainly hematological toxicity. Foreign studies suggest that combination therapy may be more suitable for patients with good basic state.Based on previous studies, this study is going to use the strategy of short-term induction chemotherapy and drug sensitivity platform to find the most suitable patients for combined therapy.

This single-arm, open, multicenter clinical study is going to evaluate the efficacy and safety of combination therapy with ectiecinib, pemetrexed and platinum in patients with metastatic non-squamous non-small cell lung cancer with EGFR mutations who did not progress after pemetrexed in combination with platinum-based chemotherapy.

Patients received two cycles of chemotherapy with pemetrexed/platinum before enrolling, followed by ectinib: ectinib 125mg/ tablet, one tablet at a time, three times a day, take orally, until disease progression;Pemetrexed 500mg/m2, intravenously administered on day 1;Carboplatin AUC6/ Cisplatin 75mg/m2,intravenously on day 1,21 days for a cycle, a total of 6 cycles.Maintenance therapy: ectinib: ectinib 125mg/ tablet, one tablet at a time, three times a day, take orally, pemetrexed 500mg/m2, intravenously on day 1,21 days for a cycle, until disease progression.Make detailed records of toxic and side effects during medication.The efficacy was evaluated using RESIST standard after every 2 cycles of the treatment, the regimen will continue until the disease progression or the appearance of not tolerable toxicity.

EGFR-positive patients with metastatic non-squamous non-small cell lung cancer who did not progress after pemetrexed combined with platinum chemotherapy

Clinical Study of Combination Therapy With Ectiecinib, Pemetrexed and Platinum in Patients With Metastatic Non-squamous Non-small Cell Lung Cancer With EGFR Mutations.

Combination Therapy With Ectiecinib, Pemetrexed and Platinum in Patients With Metastatic Non-squamous Non-small Cell Lung Cancer With EGFR Mutations Who Did Not Progress After Pemetrexed in Combination With Platinum-based Chemotherapy:a Single-arm, Open, Multicenter Clinical Study.

PFS was defined as the length of time from the date of randomization to the date of disease progression was first observed (as determined by imaging), and the number of days from the date of randomization to death if the patient died of other causes before the disease progression.

OS was defined as the length of time from the date of randomization to death from any cause.Patients who are alive as of the date of analysis will have their last contact as the cut-off date.

Objective response rate was defined as the percentage of patients whose tumor shrinkage has reached a certain point and remains there for a certain period of time, including cases of complete response and partial response.

Adverse events are unforeseeable medical conditions or deterioration of pre-existing medical conditions that occur during or after the use of a drug, regardless of whether it is related to the drug in question.

Spots Global Cancer Trial Database for the combination therapy of targeted therapy and chemotherapy