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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02407366
• Other study ID #: FGSLC-2015
• Status: Recruiting
• Phase: Phase 2
• First received: March 25, 2015
• Last updated: March 30, 2015
• Start date: December 2014
• Est. completion date: December 2017

Study information

• Verified date: March 2015
• Source: People's Hospital of Guangxi
• Contact: Xia Wu, intern
• Phone: +86-185-789-52759
• Email: 353992578[@]qq.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Icotinib
Icotinib (125 mg ,Three times daily)
• Pemetrexed
Pemetrexed(500mg/m2)every 21 days
• Carboplatin
Carboplatin (AUC,5) every 21 days

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

Locations

Country	Name	City	State
China	The people's Hospital of the Guangxi Zhuang Autonomous Region	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
People's Hospital of Guangxi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Adverse events	The number of patients who suffered adverse events, which is graded by NCI CTCAE version 4.0.	two years	Yes
Secondary	Objective response rate	Number of subjects with confirmed objective response according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.	two years	No
Secondary	Quality of life	Quality of life as measured by the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) questionnaire.	two years	Yes