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

NCT02407366 | Unknown Phase 2

• 1 other identifier: FGSLC-2015
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Keywords

Inoperable stage III non-small cell lung cancer; EGFR mutation; Icotinib; Radiotherapy; Chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  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.

  One year

Secondary Outcomes (4)

• Overall survival(OS)

  two years

• Adverse events

  two years

• Objective response rate

  two years

• Quality of life

  two years

Study Arms (2)

Icotinib with concurrent radiotherapy

EXPERIMENTAL

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; Radiation: Thoracic radiotherapy(TRT)

Chemoradiotherapy

ACTIVE COMPARATOR

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; Drug: Carboplatin; Radiation: Thoracic radiotherapy(TRT)

Interventions

Icotinib DRUG

Icotinib (125 mg ,Three times daily)

Also known as: BPI-2009, Conmana

Icotinib with concurrent radiotherapy

Pemetrexed DRUG

Pemetrexed(500mg/m2)every 21 days

Also known as: Alimta, LY231514, MTA, Multitargeted Antifolate, NSC-698037

Chemoradiotherapy

Carboplatin DRUG

Carboplatin (AUC，5) every 21 days

Also known as: Paraplatin

Chemoradiotherapy

Thoracic radiotherapy(TRT) RADIATION

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

Chemoradiotherapy; Icotinib with concurrent radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unresectable stage IIIA / IIIB non-small cell lung cancer with EGFR 19/21 mutation.
• No previous systemic anticancer therapy.
• life expectancy more than three months.
• ECOG Performance Status of 0 to 1.
• Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
• Patients will be required to provide informed consent before enrollment.

You may not qualify if:

• Intrapulmonary metastasis, atelectasis of an entire hemithorax,pleural dissemination, or contralateral hilar lymph node metastasis.
• Prior chemotherapy for NSCLC, chest irradiation therapy, or therapy directed at the epidermal growth factor receptor pathway.
• Severe heart disease, uncontrolled diabetes mellitus, or active infection.
• Active concomitant malignancy, and pregnancy or breast-feeding.

Sponsors & Collaborators

• People's Hospital of Guangxi Zhuang Autonomous Region: lead

Study Sites (1)

The people's Hospital of the Guangxi Zhuang Autonomous Region

Nanning, Guangxi, 530021, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

icotinib; Pemetrexed; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals

Study Officials

• 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 CHAIR

Central Study Contacts

Xia Wu, intern

CONTACT

+86-185-789-52759; 353992578@qq.com

XiangLi Lai, intern

CONTACT

+86-138-7719-7891; 249261276@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: April 2, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: April 2, 2015

Record last verified: 2015-03

Locations

CN (1)