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This study is a randomized, multicenter clinical study ,which is designed to compare the efficacy of the safety and efficacy of treatment every 6 weeks in EGFR positive (Non-small cell lung cancer, NSCLC) with concurrent Driver gene mutations,who used EGFR-TKI with or without combined chemotherapy,estimated with stable efficacy (CR, PR, and SD) .In this study, subjects will be randomly assigned to the following two groups according to a 1:1 ratio:(A) Standard programme group, EGFR-TKI targeted therapy; (B) controlled programme group, EGFR-TKI targeted therapy combined chemotherapy(pemetrexed plus carboplatin for 4 cycles )
This study is a randomized, multicenter clinical study aimed at EGFR positive non-small-cell lung cancer (NSCLC) subjects with concurrent Driver gene mutations who have not previously received systematic treatment. After comparing EGFR-TKI alone or EGFR-TKI combined with chemotherapy for 4 cycles, after the efficacy evaluation was stable (CR, PR, and SD), the safety and clinical efficacy of maintenance therapy every 6 weeks were compared. The eligible subjects in this study will be randomly assigned into the following two groups according to the 1: 1 ratio: (A) Standard programme group, EGFR-TKI targeted therapy; (B) controlled programme group, EGFR-TKI targeted therapy combined chemotherapy (pemetrexed plus carboplatin for 4 cycles ) During the course of the trial treatment, if the subject develops disease (the first PD), the researcher will decide whether to continue the medication according to the patient's situation and communicate with the patient, as follows: After the first PD of the subject, the researcher decides whether to continue the treatment with the original regimen according to the disease state of the subject. At least 4 weeks later, the tumor is evaluated again. If the tumor progresses again (the second PD), the subject's study treatment ends and the follow-up period is entered; if there is no progress, the original regimen is continued.
The primary end point was descriptive analysis of progression-free survival and Objective response rate.The secondary end point of this study was to compare the incidence of treatment-related grade 3-5 adverse events between the standard group and the controlled group. Using RECIST 1.1 as the evaluation standard, the independent imaging evaluation committee (IRRC) conducted the evaluation. For the first time to evaluate PD, regardless of whether they continue to study treatment after progression, the date of the first PD evaluated by IRRC will be used for all statistical analysis containing progress information.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard programme group | Experimental | EGFR-TKI targeted therapy |
|
| controlled programme group | Active Comparator | EGFR-TKI targeted therapy combined chemotherapy(pemetrexed plus carboplatin for 4 cycles ) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EGFR-TKI | Drug | (A) Standard programme group, EGFR-TKI targeted therapy; |
| |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | Patients with oncological diseases have a period of time from the start of treatment to the observation of disease progression or death due to any cause | three years |
| objective response rate | Refers to the proportion of patients whose tumor shrinkage reaches a certain amount and remains for a certain period of time, including CR + PR cases | three years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | The time from randomization to death due to any cause. For subjects who have been lost to follow-up before death, the time of the last follow-up is usually calculated as the time of death. | three years |
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Inclusion Criteria:
(1). Absolute neutrophil count >15.0 x 10^9/L; (2). Platelet count ≥ 100 x 10^9/L; (3). Hemoglobins ≥ 90 g/L; (4). Total bilirubin ≤.5 x ULN (except Gilbert syndrome, total bilirubin ≤ 3.0 mg/dL); (5). AST (SGOT) ≤ 2.5 x ULN, for patients with liver metastasis, ≤5.0 x ULN; (6). ALT (SGPT) is 2.5 x ULN, for patients with liver metastasis, ≤5.0 x ULN; (7). Clotting function: activated part of the clotting enzyme time (APTT) ≤ 1.5 x ULN, clotting enzyme raw time (PT) or international standardized ratio (INR) ≤1.5 x ULN; (8). Creatinine ≤1.5xULN, or creatinine clearance ≥60 mL/min (Cockcroft-Gault method).
11. Female patients must meet one of the following:
12. Male patients must meet the requirement to consent to abstinence (avoiding heterosexual intercourse) or to take contraception, provided that when the partner is a woman of childbearing age or who is pregnant, male patients must maintain abstinence or use condom contraception to prevent exposure to the embryo during treatment and for at least 150 days after the end of administration of the drug. Regular abstinence (e.g. calendar days, ovulation periods, basic body temperature or late-stage contraception) and in vitro ejaculation are substandard methods of contraception.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kai Wang, PhD | The Fourth Affiliated Hospital of Zhejiang University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China, Zhejiang | Hangzhou | Zhejiang | 310000 | China |
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| EGFR-TKI combined with chemotherapy (pemetrexed plus carboplatin) |
| Drug |
(B) controlled programme group, EGFR-TKI targeted therapy combined chemotherapy(pemetrexed plus carboplatin for 4 cycles ) |
|
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D000068437 | Pemetrexed |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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