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Icotinib With Concurrent Radiotherapy vs. Chemoradiotherapy in Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT02407366
Recruitment Status : Unknown
Verified March 2015 by Guosheng Feng, People's Hospital of Guangxi.
Recruitment status was:  Recruiting
First Posted : April 2, 2015
Last Update Posted : April 2, 2015
Sponsor:
Information provided by (Responsible Party):
Guosheng Feng, People's Hospital of Guangxi

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
Non-small Cell Lung Cancer Drug: Icotinib Drug: Pemetrexed Drug: Carboplatin Radiation: Thoracic radiotherapy(TRT) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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:
  • BPI-2009
  • Conmana

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:
  • Alimta
  • LY231514
  • MTA
  • Multitargeted Antifolate
  • NSC-698037

Drug: Carboplatin
Carboplatin (AUC,5) every 21 days
Other Name: Paraplatin

Radiation: Thoracic radiotherapy(TRT)
TRT (total dose 66Gy, 2Gy per time, once a day, five times a week, a total of 33 times)




Primary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: 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 :
  1. Overall survival(OS) [ Time Frame: 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.

  2. Adverse events [ Time Frame: two years ]
    The number of patients who suffered adverse events, which is graded by NCI CTCAE version 4.0.

  3. Objective response rate [ Time Frame: two years ]
    Number of subjects with confirmed objective response according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

  4. Quality of life [ Time Frame: two years ]
    Quality of life as measured by the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02407366


Contacts
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Contact: Xia Wu, intern +86-185-789-52759 353992578@qq.com
Contact: XiangLi Lai, intern +86-138-7719-7891 249261276@qq.com

Locations
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China, Guangxi
The people's Hospital of the Guangxi Zhuang Autonomous Region Recruiting
Nanning, Guangxi, China, 530021
Contact: GuoSheng Feng, professor    +86-771-218-6508    fengguosheng88988@163.com   
Sponsors and Collaborators
People's Hospital of Guangxi
Investigators
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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 Worker's Hospital
Study Chair: HaiXin Huang, MD Liuzhou Worker's 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
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Responsible Party: Guosheng Feng, Professor, People's Hospital of Guangxi
ClinicalTrials.gov Identifier: NCT02407366    
Other Study ID Numbers: FGSLC-2015
First Posted: April 2, 2015    Key Record Dates
Last Update Posted: April 2, 2015
Last Verified: March 2015
Keywords provided by Guosheng Feng, People's Hospital of Guangxi:
Inoperable stage III non-small cell lung cancer
EGFR mutation
Icotinib
Radiotherapy
Chemoradiotherapy
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carboplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors