Adenocarcinoma, EGFR Positive Non-small Cell Lung Cancer
Conditions
Brief summary
This randomised, controlled, multicentre trial is designed to assess the efficacy and safety of sequential icotinib plus chemotherapy versus single icotinib as first-line treatment in stage IIIB/IV lung adenocarcinoma patients with EGFR mutation.
Interventions
DRUGSequential Icotinib Plus Chemotherapy
Sequential icotinib plus chemotherapy: pemetrexed 500mg/m2 iv d1, cisplatin 75mg/m2 d1, icotinib 125 mg is administered orally three times per day d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4 cycles treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity.
DRUGIcotinib
Icotinib 125 mg is administered orally three times per day until disease progression or intolerable toxicity.
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
* Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT) * Patients must have previously untreated locally advanced or metastatic NSCLC * EGFR activating mutation (exon 19 deletion, L858R) is required * Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1
Exclusion criteria
* Prior chemotherapy or treatment with gefitinib, erlotinib, or other drugs that target EGFR * Patients with wild-type EGFR * Any other investigational agents are not permitted * Any evidence of interstitial lung disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | 15 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 | 24 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 | 15 months | Number of subjects with confirmed objective response according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. |
| Adverse events | 24 months | The number of patients who suffered adverse events, which is graded by NCI CTCAE version 4.0. |
Countries
China
Contacts
Primary ContactHelong Zhang, MD
Outcome results
None listed