Lung Neoplasms Clinical Trial
Official title:
Pemetrexed Disodium and Cisplatin Chemotherapy Combined With Synchronous Gefitinib vs Chemotherapy Alone as Adjuvent Therapy in Patient With Stage II-IIIA, Epidermal Growth Factor Receptor Mutant Expressing Lung Adenocarcinoma
This randomized phase III trial is studying gefitinib and synchronous pemetrexed/cisplatin chenmotherapy to see how well it works compared to pemetrexed/cisplatin chenmotherapy alone in treating patients who have undergone surgery for stage II-IIIA(N1-N2) lung adenocarcinoma with EGFR activating mutation in Asian population.
Status | Recruiting |
Enrollment | 220 |
Est. completion date | January 2020 |
Est. primary completion date | January 2018 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Written informed consent provided. - Males or females aged =18 years, < 70 years. - Able to comply with the required protocol and follow-up procedures, and able to receive oral medications. - Target population is completely resected pathological stage II-IIIA(N1-N2) NSCLC with EGFR exon 19 deletions and exon 21 L858R activating mutation. - Patient who can start the investigational therapy within 3-6 weeks after the complete resection - ECOG performance status 0-1. - Life expectancy =12 weeks. - Adequate hematological function: Absolute neutrophil count (ANC) =2.0 x 109/L, and Platelet count =100 x 109/L, and Hemoglobin =9 g/dL (may be transfused to maintain or exceed this level). - Adequate liver function: Total bilirubin = 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) = 2.5 x ULN in subjects without liver metastases; = 5 x ULN in subjects with liver metastases. - Adequate renal function: Serum creatinine = 1.25 x ULN, or = 60 ml/min. - Female subjects should not be pregnant or breast-feeding. Exclusion Criteria: - Known severe hypersensitivity to gefitinib or any of the excipients of this product. - Known severe hypersensitivity to pre-medications required for treatment with cisplatin / vinorelbine doublet chemotherapy. - Inability to comply with protocol or study procedures. - A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study. - A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease. - Interstitial pneumonia. - Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab). - Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g. monoclonal antibody therapy). - Patients with prior radiotherapy - History of another malignancy in the last 5 years with the exception of the following:Other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted. Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted. - Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease). - Eye inflammation or eye infection not fully treated or conditions predisposing the subject to this. - Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or puts the subject at high risk for treatment-related complications. - Patient who has active serious infection (e.g. pyrexia of or 38.0? over) - Patients who harbouring exon 20 T790M mutation. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Tangdu Hospital of the Fourth Millitary Medical University | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
Tang-Du Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease free survival | To evaluate the disease free survival of synchronous therapy versus combination of Pemetrexed plus Cisplatin as adjuvant treatment for pathological stage II-IIIA(N1-N2) lung adenocarcinoma with EGFR mutation.Disease free survival (DFS)- defined as the time from randomization to the first documented disease progression or death, whichever occurs first. | From date of randomization to the first documented disease progression or death, whichever occurs first, assessed up to 3 and 5 years. | No |
Secondary | Overall survival | To evaluate the overall survival of synchronous therapy versus combination of Pemetrexed plus Cisplatin as adjuvant treatment for stage II-IIIA(N1-N2) lung adenocarcinoma with EGFR mutation. | From date of randomization to the first documented death, assessed up to 5 years. | No |
Secondary | Number of Participants with Adverse Events | The safety and tolerability profile of gefitinib at a 250 mg daily dose relative to that of Chemotherapy. | In the period of Gefitinib 250 mg/day oral daily for 24 months. Pemetrexed 500 mg/m2 intravenous infusion on day 1, Cisplatin 75 mg/m2 on day 1 for 4 cycles. | Yes |
Secondary | Quality of life | Quality of life as measured by the total score and Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) questionnaire. | In the period of Gefitinib 250 mg/day oral daily for 24 months. Pemetrexed 500 mg/m2 intravenous infusion on day 1, Cisplatin 75 mg/m2 on day 1 for 4 cycles. | No |
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