Non-small Cell Lung Cancer
Conditions
Brief summary
This study was a single-arm, multi-center, prospective, phase 3 trial aimed to evaluate the efficacy and safety of icotinib in patients with locally advanced or metastatic NSCLC after failure of at least one platinum-based chemotherapy regimen.
Interventions
DRUGicotinib
Patients were administered with oral icotinib (tablet form, 125 mg) three times daily within two days after enrollment until disease progression or unacceptable toxicity.
Sponsors
Betta Pharmaceuticals Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed locally advanced/metastatic (stage IIIB/stage IV, using the American Joint Committee on Cancer \[AJCC\] 6th edition of tumor-node-metastasis \[TNM\] staging system) NSCLC patients * Progressed after at least one platinum-based chemotherapy regimen at entry * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 * At least one measurable lesion by Response Evaluation Criteria in Solid Tumors version 1.0 * Adequate hematologic and biochemical values
Exclusion criteria
* Patients with symptomatic brain metastases * Malignant tumor within the previous five years * Severe infection; congestive heart failure * Previous treatment with drugs targeting EGFR * History of interstitial lung disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| overall survival | 12 months |
| objective response rate | 2 months |
| number of patients suffered adverse events | 15 months |
Countries
China
Outcome results
None listed