Non-small Cell Lung Cancer
Conditions
Brief summary
Eligible patients are administered with oral icotinib 125mg three times daily for two months, in which responsive patients (partial response and stable disease) are randomized (1: 1: 1) and receive icotinib plus concurrent radiotherapy, or chemotherapy plus concurrent radiotherapy, or icotinib monotherapy.
Detailed description
Eligible patients are administered with oral icotinib 125mg three times daily for two months, in which responsive patients (partial response and stable disease) are randomized (1: 1: 1) and receive icotinib plus concurrent radiotherapy, or chemotherapy plus concurrent radiotherapy, or icotinib monotherapy. The primary endpoint is progression-free survival, and the incidence of radiation-induced lung injury.
Interventions
DRUGicotinib
Icotinib is orally administered three times per day.
DRUGChemotherapy
Chemotherapy is given by intravenous administration. Three regimens are available in this study. Regimen 1: etoposide 75mg/m2 d1-5 + cisplatin 75 mg/m2 day1/ day1-2. Regimen 2: docetaxel 75mg/m2 d1 + cisplatin 75 mg/m2 day1/ day1-2. Regimen 3: pemetrexed 500mg/m2 d1 + cisplatin 75 mg/m2 day1/ day1-2
RADIATIONRadiotherapy
5Gy/75.00Gy, 10f/2w for peripheral lung cancer, and 2.4Gy/59.52Gy, 20f/4w for central lung cancer.
Sponsors
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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
* Aged 18 to 75 years * Pathologically documented NSCLC * Unresectable stage III or oligometastasis (less than three metastasis lesions, brain metastasis is not permitted) stage IV confirmed by CT and/or MRI * Positive EGFR mutation confirmed by ARMS * At least 3-month life expectancy * KPS ≥ 70 * Adequate hematological values: hemoglobin ≥ 100 g/L, absolute neutrophils count ≥ 1.5 x 109/L, platelets count ≥ 100 x 109/L * Adequate hepatic function: bilirubin ≤ 1.5 x ULN, AST/ALT ≤ 1.5 x ULN * Written informed consent before patient registration and any protocol-related procedures
Exclusion criteria
* Previous radiotherapy * Received other investigational systemic drugs within 4 weeks prior to study entry * Severe or uncontrolled systemic disease * Active autoimmune disease, or a documented history of autoimmune/acquired immune disease, or a history of organ transplant * Pregnant or lactating, women of childbearing potential, unless using effective contraception as determined by the investigator * Any other serious underlying medical (e.g. active uncontrolled infection, active gastric ulcer, uncontrolled seizures), psychological and other condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 2 years | — |
| Incidence of radiation injure of the lungs | 2 years | Measured according to NCI CTCAE v4.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 5 years | — |
| Tumor response after icotinib induction | 8 weeks | — |
| Quality of life | 2 years | Measured by FACT-L |
Outcome results
None listed