Non-Small-Cell Lung Cancer
Conditions
Brief summary
Objective: To compare the efficacy and safety of chemotherapy plus intercalated EGFR-tyrosine kinase inhibitors (TKI) combination therapy with TKI alone therapy as first-line treatment for patients with non-small-cell lung cancer (NSCLC). Methods: Patients with untreated, stage IIIB/IV, EGFR mutation-positive NSCLC will be randomly assigned to combination therapy group (receiving four cycles of docetaxel or pemetrexed (on day 1) plus platinum (on day 1) with intercalated TKI (gefitinib, erlotinib or Icotinib, on day 2-15) every 3 weeks) or TKI alone therapy (gefitinib, erlotinib or Icotinib, daily). All patients were continued to receive TKI until progression or unacceptable to toxicity or death. The primary endpoint was progression-free survivial (PFS). Expected results: PFS of combination therapy group will be prolonged to nineteen months while PFS of TKI alone therapy group is ten months. Overall survival (OS) of combination therapy group will be prolonged to 36 months while OS of TKI alone therapy group is 26 months. Hypothesis: Platinum-based chemotherapy plus intercalated TKI combination therapy as first-line treatment will prolong PFS and OS for patients with NSCLC.
Interventions
DRUGErlotinib
150mg po once a day on days 2-15 of each 3 week cycle for 4 cycles; then continue to receive erlotinib150mg po once a day daily until progression
DRUGGefitinib
250mg po once a day on days 2-15 of each 3 week cycle for 4 cycles; then continue to receive gefitinib 250mg po once a day daily until progression
DRUGIcotinib
125mg po three time a day on days 2-15 of each 3 week cycle for 4 cycles; then continue to receive icotinib 125mg po three time a day daily until progression
DRUGDocetaxel
75 mg/m2 ivgtt on days 1 of each 3 week cycle for 4 cycles
DRUGPemetrexed
500 mg/m2 ivgtt on days 1 of each 3 week cycle for 4 cycles
cisplatin -- 75mg/m2 ivgtt on day 1 of each 3 week cycle for 4 cycles or carboplatin -- 5 x AUC ivgtt on day 1 of each 3 week cycle for 4 cycles
Sponsors
Qilu Hospital of Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients, \>=18 years of age; * Advanced (stage IIIB/IV) non-small-cell lung cancer; * Although stageⅠ-ⅢA, have contraindications to surgery; * EGFR mutation-positive (EGFR exon-18, exon-19 or exon-21); * Measurable disease; * ECOG Performance Status 0 or 1 or 2.
Exclusion criteria
* Wild-type EGFR; * Prior exposure to agents directed at the HER axis; * Prior chemotherapy or systemic anti-tumor therapy after advanced disease; * Unstable systemic disease; * Any other malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix; * Brain metastasis or spinal cord compression.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | 8 weeks | Progression-free survival (PFS) is defined to be the time from randomization to progression of disease or death, whichever occurs first. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response | 8 weeks |
| Time to progression | 8 weeks |
| Objective response rate | 8 weeks |
| Clinical benefit rate | 8 weeks |
| Adverse Events (AEs), Serious Adverse Events (SAEs), laboratory data | 4 weeks |
| Overall survival (OS) | 8 weeks |
Countries
China
Contacts
Primary ContactQian Qi, MS
Outcome results
None listed