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

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

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.

Study Overview

• Status: Unknown
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Icotinib; Radiation: Thoracic radiotherapy(TRT); Drug: Pemetrexed; Drug: Carboplatin

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Recruiting
      • The people's Hospital of the Guangxi Zhuang Autonomous Region
      • Contact: GuoSheng Feng, professor; Phone Number: +86-771-218-6508; Email: fengguosheng88988@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 .	Radiation: Thoracic radiotherapy(TRT); TRT (total dose 66Gy, 2Gy per time, once a day, five times a week, a total of 33 times); 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 Names: Paraplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival(OS)	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.	two years
Adverse events	The number of patients who suffered adverse events, which is graded by NCI CTCAE version 4.0.	two years
Objective response rate	Number of subjects with confirmed objective response according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.	two years
Quality of life	Quality of life as measured by the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) questionnaire.	two years

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: March 25, 2015
• First Submitted That Met QC Criteria: March 30, 2015
• First Posted (Estimate): April 2, 2015

Study Record Updates

• Last Update Posted (Estimate): April 2, 2015
• Last Update Submitted That Met QC Criteria: March 30, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Radiotherapy; Chemoradiotherapy; EGFR mutation; Icotinib; Inoperable stage III non-small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Folic Acid Antagonists; Carboplatin; Pemetrexed
• Other Study ID Numbers: FGSLC-2015