Non-small Cell Lung Cancer
Conditions
Keywords
Inoperable stage III non-small cell lung cancer, EGFR mutation, Icotinib, Radiotherapy, Chemoradiotherapy
Brief summary
The current standard of care for unresectable locally advanced non-small-cell lung cancer (NSCLC) is a combination of chemotherapy and thoracic radiotherapy (TRT). The standard regimens consist of platinum-based doublet chemotherapy.Icotinib(BPI-2009, Conmana) is the first self-developed small molecular drug in China for targeted therapy of lung cancer.Icotinib is a novel oral quinazoline compound that has proven survival benefit in Chinese patients with lung cancer,especially in EGFR mutation lung cancer. This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus pemetrexed + carboplatin with concurrent radiotherapy in inoperable stage III non-small cell lung cancer with EGFR mutation, the primary endpoint is progression-free survival.
Interventions
DRUGIcotinib
Icotinib (125 mg ,Three times daily)
DRUGPemetrexed
Pemetrexed(500mg/m2)every 21 days
DRUGCarboplatin
Carboplatin (AUC，5) every 21 days
RADIATIONThoracic radiotherapy(TRT)
TRT (total dose 66Gy, 2Gy per time, once a day, five times a week, a total of 33 times)
Sponsors
People's Hospital of Guangxi Zhuang Autonomous Region
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
1. Unresectable stage IIIA / IIIB non-small cell lung cancer with EGFR 19/21 mutation. 2. No previous systemic anticancer therapy. 3. life expectancy more than three months. 4. ECOG Performance Status of 0 to 1. 5. Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site. 6. Patients will be required to provide informed consent before enrollment.
Exclusion criteria
1. Intrapulmonary metastasis, atelectasis of an entire hemithorax,pleural dissemination, or contralateral hilar lymph node metastasis. 2. Prior chemotherapy for NSCLC, chest irradiation therapy, or therapy directed at the epidermal growth factor receptor pathway. 3. Severe heart disease, uncontrolled diabetes mellitus, or active infection. 4. Active concomitant malignancy, and pregnancy or breast-feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | One year | 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(OS) | two years | 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. |
| Adverse events | two years | The number of patients who suffered adverse events, which is graded by NCI CTCAE version 4.0. |
| Objective response rate | two years | Number of subjects with confirmed objective response according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. |
| Quality of life | two years | Quality of life as measured by the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) questionnaire. |
Countries
China
Contacts
Primary ContactXia Wu, intern
Backup ContactXiangLi Lai, intern
Outcome results
None listed