NCT02407366

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: People's Hospital of Guangxi Zhuang Autonomous Region · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Icotinib	Icotinib (125 mg ,Three times daily)
DRUG	Pemetrexed	Pemetrexed(500mg/m2)every 21 days
DRUG	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)

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-12-01
• Completion: 2017-12-01
• First posted: 2015-04-02
• Last updated: 2015-04-02

Locations

1 site across 1 country: China