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

NCT ID: NCT02407366

Last Updated: 2015-04-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2017-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Icotinib

Intervention Type: DRUG

Icotinib (125 mg ,Three times daily)

Thoracic radiotherapy(TRT)

Intervention Type: RADIATION

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

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 .

Group Type: ACTIVE_COMPARATOR

Pemetrexed

Intervention Type: DRUG

Pemetrexed(500mg/m2)every 21 days

Carboplatin

Intervention Type: DRUG

Carboplatin (AUC，5) every 21 days

Thoracic radiotherapy(TRT)

Intervention Type: RADIATION

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

Interventions

Icotinib

Icotinib (125 mg ,Three times daily)

Intervention Type: DRUG

Pemetrexed

Pemetrexed(500mg/m2)every 21 days

Intervention Type: DRUG

Carboplatin

Carboplatin (AUC，5) every 21 days

Intervention Type: DRUG

Thoracic radiotherapy(TRT)

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

Intervention Type: RADIATION

Other Intervention Names

BPI-2009; Conmana; Alimta; LY231514; MTA; Multitargeted Antifolate; NSC-698037; Paraplatin

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

People's Hospital of Guangxi Zhuang Autonomous Region

OTHER

Sponsor Role: lead

Responsible Party

Guosheng Feng

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

GuoSheng Feng, MD

Role: STUDY_CHAIR

The People's hospital of Guangxi Zhuang Autonomous

Yuan Liang, MD

Role: STUDY_CHAIR

Guangxi Department of Public Health

Lin Hui, MD

Role: STUDY_CHAIR

The People's hospital of Guangxi Zhuang Autonomous

HeMing Lu, MD

Role: STUDY_CHAIR

The People's hospital of Guangxi Zhuang Autonomous

ChangJie Huang, MD

Role: STUDY_CHAIR

Nanning Second People's Hospital

GuiSheng LI, MD

Role: STUDY_CHAIR

Liuzhou Workers' Hospital

HaiXin Huang, MD

Role: STUDY_CHAIR

Liuzhou Workers' Hospital

HaoLin Yan, MD

Role: STUDY_CHAIR

First People's Hospital of Yulin

Ping Liang, MD

Role: STUDY_CHAIR

Guangxi Ruikang Hospital

BingQiang Ni, MD

Role: STUDY_CHAIR

The People's hospital of LiuZhou

YanRong Hao, MD

Role: STUDY_CHAIR

The People's hospital of Guangxi Zhuang Autonomous

XianBin Yuan, MD

Role: STUDY_CHAIR

The People's hospital of Guangxi Zhuang Autonomous

Shan Gao, MD

Role: STUDY_CHAIR

The People's hospital of Guangxi Zhuang Autonomous

Xia Wu, MD

Role: STUDY_CHAIR

The People's hospital of Guangxi Zhuang Autonomous

XiangLi Lai, MD

Role: STUDY_CHAIR

The People's hospital of Guangxi Zhuang Autonomous

Locations

The people's Hospital of the Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xia Wu, intern

Role: CONTACT

353992578@qq.com

+86-185-789-52759

XiangLi Lai, intern

Role: CONTACT

249261276@qq.com

+86-138-7719-7891

Facility Contacts

GuoSheng Feng, professor

Role: primary

fengguosheng88988@163.com

+86-771-218-6508

Other Identifiers

FGSLC-2015

Identifier Type: -

Identifier Source: org_study_id