drugset / Trial / NCT03758677

Apatinib Combined With Chemotherapy for NSCLC Patients Without T790M Mutation

NCT03758677 ↗

Phase 2 Unknown 30 enrolled The First Hospital of Jilin University
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2020-08-01
Primary completion
2020-11-20
Completion
2021-11-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Rivoceranib Small molecule 250 mg Oral
Background Docetaxel Small molecule — —
Background Gemcitabine Small molecule — —
Background Pemetrexed Small molecule — —