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Report for Clinical Trial NCT03758677

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Prospective, Single-center, One-arm Clinical Study of Apatinib Combined With Chemotherapy for Patients Who Progressed After First Line EGFR-TKI Treatment Without T790M Mutation

At present, with the increasing intensities of the tobacco industry and air pollution in China, the incidence and mortality of lung cancer have become the most important issue that threatens human health.Over the past two decades, the treatment of EGFR+ NSCLC is molecular target therapy (EGFR-TKI). However, only about 30 percent patients with T790M mutation could accept 3rd generation of EGFR-TKI(AZD9291) , most of the patients with progressive disease statuses still stays in the mode of treatment based on radiotherapy and chemotherapy. This is a prospective, single-center, one-arm clinical study designed to evaluate the efficacy and safety of apatinib plus chemotherapy for 30 patients who progressed after EGFR-TKI treatment without T790M mutation. The participants will receive apatinib 250mg qd orally combine with chemotherapy, if the patient has a grade 3/4 adverse reaction during such treatment, it can be reduced to apatinib 250mg orally once per two days. Chemotherapeutic agents are limited to platinum-based double drugs chemotherapy.The primary outcome endpoint was progression-free survival.

NCT03758677 Non Small Cell Lung Cance Non Small Cell Lung Cancer
MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma

1 Interventions

Name: Apatinib

Description: 30 patients who progressed after EGFR-TKI treatment without T790M mutation will receive apatinib 250mg qd orally combine with chemotherapy , if the patient has a grade 3/4 adverse reaction during such treatment, apatinib should be reduced to 250mg orally once per two days. Chemotherapeutic agents are limited to platinum-based double drugs(Pemetrexed,Gemcitabine,Docetaxel).
Type: Drug
Group Labels: 1

Patients who progressed after EGFR-TKI without T790M mutation


Primary Outcomes

Description: Progression-free survival

Measure: PFS

Time: One to two years

Secondary Outcomes

Description: Overall survival

Measure: OS

Time: Five years

Description: Adverse events

Measure: AEs

Time: One year

Description: Disease control rate

Measure: DCR

Time: One year

Description: Objective response rate

Measure: ORR

Time: One year

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 T790M

A Prospective, Single-center, One-arm Clinical Study of Apatinib Combined With Chemotherapy for Patients Who Progressed After First Line EGFR-TKI Treatment Without T790M Mutation. --- T790M ---

Apatinib Combined With Chemotherapy for NSCLC Patients Without T790M Mutation At present, with the increasing intensities of the tobacco industry and air pollution in China, the incidence and mortality of lung cancer have become the most important issue that threatens human health.Over the past two decades, the treatment of EGFR+ NSCLC is molecular target therapy (EGFR-TKI). --- T790M ---

However, only about 30 percent patients with T790M mutation could accept 3rd generation of EGFR-TKI(AZD9291) , most of the patients with progressive disease statuses still stays in the mode of treatment based on radiotherapy and chemotherapy. --- T790M ---

This is a prospective, single-center, one-arm clinical study designed to evaluate the efficacy and safety of apatinib plus chemotherapy for 30 patients who progressed after EGFR-TKI treatment without T790M mutation. --- T790M ---

Inclusion Criteria: 1. male or female patients: 18-75 years old; 2. ECOG performance status score: 0~2 points; 3. Non small cell lung cancer patients who progressed after first line EGFR -TKI treatment without T790M mutation 4.Expected survival period ≥12 weeks; 5.The normal function of major organs, that is, the relevant inspection indicators within the first 14 days of randomness, meet the following requirements: 1. Blood tests: 1. Hemoglobin ≥ 90 g/L (without transfusion in 14 days); 2. Neutrophil count ≥ 1.5×109/L; 3. Platelet count ≥ 100×109/L; 2. Biochemical check: a .total --- T790M ---



HPO Nodes


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