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Report for Clinical Trial NCT03856697

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Randomized Controlled, Double-blind, Multicenter, Phase III Clinical Study to Compare Efficacy and Safety of Abivertinib Maleate Versus First-line Standard Therapy EGFR-TKI in Patients With Advanced NSCLC With Sensitive EGFR Mutation

To compare efficacy and safety of Abivertinib maleate alone versus standard first-line EGFR-TKIs for the treatment of patients with advanced non-small cell lung cancer with sensitive EGFR mutation

NCT03856697 Advanced Non-small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

4 Interventions

Name: Abivertinib Maleate Capsules

Description: patients receive the test drug (Abivertinib maleate Capsules) since the first day of cycle 1. One cycle is defined as 21 days. The patient shall take the study drugs twice a day. The first dose is 3 capsules, and the second dose is 3 capsules. The drugs should be administered with water before or after meals.
Type: Drug
Group Labels: 1

Abivertinib Maleate Capsules+ Placebo Gefitinib Tablets

Name: Placebo Gefitinib Tablets

Description: patients receive the test drug (Placebo Gefitinib Tablets) since the first day of cycle 1. One cycle is defined as 21 days. The patient shall take the study drugs twice a day. The first dose is 1 tablet. The drugs should be administered with water before or after meals.
Type: Drug
Group Labels: 1

Abivertinib Maleate Capsules+ Placebo Gefitinib Tablets

Name: Gefitinib Tablets

Description: patients receive the control drug (Gefitinib Tablets) since the first day of cycle 1. One cycle is defined as 21 days. The patient shall take the study drugs twice a day. The first dose is 1 tablet. The drugs should be administered with water before or after meals.
Type: Drug
Group Labels: 1

Gefitinib Tablets+ Placebo Abivertinib Maleate Capsules

Name: Placebo Abivertinib Maleate Capsules

Description: patients receive the control drug (Placebo Abivertinib Maleate Capsules) since the first day of cycle 1. One cycle is defined as 21 days. The patient shall take the study drugs twice a day. The first dose is 3 capsules, and the second dose is 3 capsules. The drugs should be administered with water before or after meals.
Type: Drug
Group Labels: 1

Gefitinib Tablets+ Placebo Abivertinib Maleate Capsules


Primary Outcomes

Description: Progression-free survival (PFS) of Abivertinib maleate alone versus standard first-line EGFR-TKI for the treatment of treatment-naïve patients with advanced non-small cell lung cancer with sensitive EGFR mutation (Investigator's evaluation according to RECIST1.1 criteria)

Measure: Assess the efficacy of Abivertinib: Progression Free Survival (PFS)

Time: From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

Secondary Outcomes

Description: Objective Response Rate (ORR) of Abivertinib maleate alone versus standard first-line EGFR-TKI for the treatment of treatment-naïve patients with advanced non-small cell lung cancer with sensitive EGFR mutation

Measure: Objective Response Rate (ORR)

Time: At baseline and every 6 weeks until the date of first documented progression or date of death from any cause ( approximately 12 months)

Description: Disease Control Rate (DCR) of Abivertinib maleate alone versus standard first-line EGFR-TKI for the treatment of treatment-naïve patients with advanced non-small cell lung cancer with sensitive EGFR mutation

Measure: Disease Control Rate (DCR)

Time: At baseline and every 6 weeks until the date of first documented progression or date of death from any cause ( approximately 12 months)

Description: Duration of Response (DoR) of Abivertinib maleate alone versus standard first-line EGFR-TKI for the treatment of treatment-naïve patients with advanced non-small cell lung cancer with sensitive EGFR mutation

Measure: Duration of Response (DoR)

Time: At baseline and every 6 weeks until the date of first documented progression or date of death from any cause ( approximately 12 months)

Description: Overall Survival (OS) of Abivertinib maleate alone versus standard first-line EGFR-TKI for the treatment of treatment-naïve patients with advanced non-small cell lung cancer with sensitive EGFR mutation

Measure: Overall Survival (OS)

Time: From first dose to end of study or date of death from any cause, whichever comes first, assessed every 6 weeks (approximately 36 months)

Description: Number and severity of AEs/SAEs of Abivertinib maleate alone versus standard first-line EGFR-TKI for the treatment of treatment-naïve patients with advanced non-small cell lung cancer with sensitive EGFR mutation

Measure: Safety and Resistance: Number and severity of AEs/SAEs

Time: From screening to the end of survival follow-up, which is assessed through study completion until 30 days after discontinuation

Description: The mean, standard deviation, maximum, minimum, and median of drug exposures in the two groups are described

Measure: Safety and Resistance: Drug exposure

Time: Continuously throughout the study until 30days after discontinuation

Description: A general physical examination includes: general status, skin, head and neck (includes: eyes, ears, nose, throat), respiratory system, cardiovascular system, abdomen,superficial lymph nodes, thyroid, musculoskeletal system (including spine and limbs), and nervous system, and any other physical signs of clinical significance. During the treatment, physical examination of the potentially affected organs will be performed.

Measure: Safety and Resistance: General physical examination status

Time: Continuously throughout the study until 30days after discontinuation

Description: Descriptive statistical analysis of clinical diagnosis results of ECG examination and changes compared with baseline are performed at planned time points, and abnormal ECG examination results are listed.

Measure: Safety and Resistance: Electrocardiogram(ECG test)

Time: Continuously throughout the study until 30days after discontinuation

Description: ECOG (Eastern Clinical Oncology Group) Performance Status Grading Criteria: Range from 0-5, 0 considered to be the best outcome and 5 to be the worst outcome

Measure: Safety and Resistance: Eastern Clinical Oncology Group Scores

Time: Continuously throughout the study until 30days after discontinuation

Description: Quality of life questionnaire of Abivertinib maleate alone versus standard which includes 5 functional domains, 3 symptom domains, 1 overall health status/quality of life domain and 6 single entries. Standardized scores of the domains/single entries in the questionnaire are used to statistically describe the absolute values and changes from baseline at each evaluation time point; t test is used to compare changes from baseline in overall quality of life score at each evaluation time point in both groups; analysis of variance is used to compare changes in overall health status score at each evaluation time point between the two groups. first-line EGFR-TKI for the treatment of treatment-naïve patients with advanced non-small cell lung cancer with sensitive EGFR mutation

Measure: Questionnaire: Health-related quality of life (HRQoL)

Time: At baseline and every 6 weeks until the date of first documented progression or date of death from any cause ( approximately 12 months)

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 L858R

4. Tumor tissue or cytopathological specimens have any of two common sensitive EGFR mutation (Ex19del or L858R) as confirmed by tests with Cobas (Roche) kit in central lab of this study, which can be combined with other EGFR gene mutations. --- L858R ---



HPO Nodes


HPO: