NSCLC
Conditions
Brief summary
The purpose of this study is to compare icotinib with induction and maintenance chemotherapy in the first-line treatment of advanced non-small cell lung cancer (NSCLC) patients with EGFR mutation.
Detailed description
This study is designed to evaluate the efficacy and safety of icotinib and pemetrexed-based first-line induction and maintenance chemotherapy in advanced lung adenocarcinoma with EGFR-mutation，primary endpoint is progress-free survival，second endpoints include overall survival, time to progression, and so on.
Interventions
DRUGIcotinib
Icotinib: 125 mg is administered orally three times per day.
DRUGChemotherapy
First-line chemotherapy: pemetrexed/cisplatin for 4 cycles. Maintenance treatment: pemetrexed.
Sponsors
Betta Pharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients. * Positive EGFR Mutation. * No previous systemic anticancer therapy. * Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site. * Provision of written informed consent.
Exclusion criteria
* Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab. * Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded). * Known severe hypersensitivity to icotinib or any of the excipients of this product. * Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | 12 months | A duration from randomization date to disease progression(as defined by RECIST) or death. If a participant are known to have progressed, the time to progression is defined as the time from the date of randomization to the date of progression. Otherwise, a participant will be censored at the last date they are known not to be progressed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 20 months | Overall Survival is assessed via calculation of the time to death due to any cause. If a participant is known to have died, the time to death is defined as the time from the date of randomization to the date of death. Otherwise, a participant will be censored at the last date they are known to be alive. |
| Objective response rate | 12 weeks | Number of participants who achieve complete response or partial response. Either complete response (CR) or partial response (PR) will be evaluated by RECIST, confirmed at least 28 days following the date of the initial response. |
Countries
China
Outcome results
None listed