Apatinib Combined With Chemotherapy for NSCLC Patients Without T790M Mutation

Sponsor
The First Hospital of Jilin University
Study ID
NCT03758677
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Apatinib — DRUG
    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).

Study Details

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.

Key Dates

Start date
Aug 1, 2020
Status verified
Jul 2020
Primary completion
Nov 20, 2020
Completion
Nov 20, 2021

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients who progressed after EGFR-TKI without T790M mutation
    Single arm; Plan to enroll 30 cases; Patients who progressed after EGFR-TKI treatment without T790M mutation

Primary Outcome Measure

PFS [ Time Frame: One to two years ]

Central Contacts

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