Clinical trial NCT02407366: Icotinib With Concurrent Radiotherapy vs. Chemoradiotherapy in Non-small Cell Lung Cancer
Official title: A Phase 2 Study of Icotinib With Concurrent Radiotherapy vs. Pemetrexed+ Carboplatin With Concurrent Radiotherapy in Unresectable Stage III Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor ( EGFR) Mutation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Inoperable stage III non-small cell lung cancer
EGFR mutation
Icotinib
Radiotherapy
Chemoradiotherapy
Lead sponsor: People's Hospital of Guangxi Zhuang Autonomous Region
Sponsor class: OTHER
First posted: 2015-04-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: One year
Secondary outcomes:
measure: Overall survival(OS)
timeFrame: two years
measure: Adverse events
timeFrame: two years
measure: Objective response rate
timeFrame: two years
measure: Quality of life
timeFrame: two years
Other outcomes:
Locations:
city: Nanning
country: China
facility: The people's Hospital of the Guangxi Zhuang Autonomous Region
state: Guangxi
Study officials:
affiliation: The People's hospital of Guangxi Zhuang Autonomous
name: GuoSheng Feng, MD
role: STUDY_CHAIR
affiliation: Guangxi Department of Public Health
name: Yuan Liang, MD
role: STUDY_CHAIR
affiliation: The People's hospital of Guangxi Zhuang Autonomous
name: Lin Hui, MD
role: STUDY_CHAIR
affiliation: The People's hospital of Guangxi Zhuang Autonomous
name: HeMing Lu, MD
role: STUDY_CHAIR
affiliation: Nanning Second People's Hospital
name: ChangJie Huang, MD
role: STUDY_CHAIR
affiliation: Liuzhou Workers Hospital
name: GuiSheng LI, MD
role: STUDY_CHAIR
affiliation: Liuzhou Workers Hospital
name: HaiXin Huang, MD
role: STUDY_CHAIR
affiliation: First People's Hospital of Yulin
name: HaoLin Yan, MD
role: STUDY_CHAIR
affiliation: Guangxi Ruikang Hospital
name: Ping Liang, MD
role: STUDY_CHAIR
affiliation: The People's hospital of LiuZhou
name: BingQiang Ni, MD
role: STUDY_CHAIR
affiliation: The People's hospital of Guangxi Zhuang Autonomous
name: YanRong Hao, MD
role: STUDY_CHAIR
affiliation: The People's hospital of Guangxi Zhuang Autonomous
name: XianBin Yuan, MD
role: STUDY_CHAIR
affiliation: The People's hospital of Guangxi Zhuang Autonomous
name: Shan Gao, MD
role: STUDY_CHAIR
affiliation: The People's hospital of Guangxi Zhuang Autonomous
name: Xia Wu, MD
role: STUDY_CHAIR
affiliation: The People's hospital of Guangxi Zhuang Autonomous
name: XiangLi Lai, MD
role: STUDY_CHAIR
References: