Icotinib With Concurrent Radiotherapy vs. Chemoradiotherapy in Non-small Cell Lung Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Icotinib with concurrent radiotherapy Icotinib (125 mg ,three times daily)with concurrent thoracic radiotherapy(TRT) (66 Gy/33 fractions), followed by maintenance icotinib (125 mg ,Three times daily) until disease progression or unacceptable toxicity. |
Drug: Icotinib
Icotinib (125 mg ,Three times daily)
Other Names:
Radiation: Thoracic radiotherapy(TRT)
TRT (total dose 66Gy, 2Gy per time, once a day, five times a week, a total of 33 times)
|
| Active Comparator: Chemoradiotherapy Pemetrexed(500mg/m2) + carboplatin (AUC，5) every 21 days for three cycles with concurrent thoracic radiotherapy(TRT) (66 Gy/33 fractions), followed by consolidation chemotherapy with two cycles of pemetrexed(500mg/m2) + carboplatin (AUC，5) every 21 days.Maintenance pemetrexed(500mg/m2) will be administered after consolidation chemotherapy until disease progression or unacceptable toxicity . |
Drug: Pemetrexed
Pemetrexed(500mg/m2)every 21 days
Other Names:
Drug: Carboplatin
Carboplatin (AUC，5) every 21 days
Other Names:
Radiation: Thoracic radiotherapy(TRT)
TRT (total dose 66Gy, 2Gy per time, once a day, five times a week, a total of 33 times)
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Unresectable stage IIIA / IIIB non-small cell lung cancer with EGFR 19/21 mutation.
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No previous systemic anticancer therapy.
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life expectancy more than three months.
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ECOG Performance Status of 0 to 1.
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Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
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Patients will be required to provide informed consent before enrollment.
Exclusion Criteria:
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Intrapulmonary metastasis, atelectasis of an entire hemithorax,pleural dissemination, or contralateral hilar lymph node metastasis.
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Prior chemotherapy for NSCLC, chest irradiation therapy, or therapy directed at the epidermal growth factor receptor pathway.
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Severe heart disease, uncontrolled diabetes mellitus, or active infection.
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Active concomitant malignancy, and pregnancy or breast-feeding.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The people's Hospital of the Guangxi Zhuang Autonomous Region | Nanning | Guangxi | China | 530021 |
Sponsors and Collaborators
- People's Hospital of Guangxi
Investigators
- Study Chair: GuoSheng Feng, MD, The People's hospital of Guangxi Zhuang Autonomous
- Study Chair: Yuan Liang, MD, Guangxi Department of Public Health
- Study Chair: Lin Hui, MD, The People's hospital of Guangxi Zhuang Autonomous
- Study Chair: HeMing Lu, MD, The People's hospital of Guangxi Zhuang Autonomous
- Study Chair: ChangJie Huang, MD, Nanning Second People's Hospital
- Study Chair: GuiSheng LI, MD, Liuzhou Workers Hospital
- Study Chair: HaiXin Huang, MD, Liuzhou Workers Hospital
- Study Chair: HaoLin Yan, MD, First People's Hospital of Yulin
- Study Chair: Ping Liang, MD, Guangxi Ruikang Hospital
- Study Chair: BingQiang Ni, MD, The People's hospital of LiuZhou
- Study Chair: YanRong Hao, MD, The People's hospital of Guangxi Zhuang Autonomous
- Study Chair: XianBin Yuan, MD, The People's hospital of Guangxi Zhuang Autonomous
- Study Chair: Shan Gao, MD, The People's hospital of Guangxi Zhuang Autonomous
- Study Chair: Xia Wu, MD, The People's hospital of Guangxi Zhuang Autonomous
- Study Chair: XiangLi Lai, MD, The People's hospital of Guangxi Zhuang Autonomous
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FGSLC-2015