NCT03074864

Targeted Treatment With Intercalated Radiotherapy in EGFR-mutant IIIA/IIIB NSCLC

Intercalated Combination of Erlotinib and Radiotherapy for Patients With EGFR-mutant, Unresectable, Locally Advanced Non-small-cell Lung Cancer

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Guangdong Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to investigate the efficacy and safety of intercalated combination of erlotinib and radiotherapy for patients with EGFR-mutant, unresectable, locally advanced NSCLC, and to explore a new treatment strategy for this subset. After Induction by erlotinib, local radiotherapy is intercalated, and followed by 24-week erlotinib maintenance.

Detailed description

Chemoradiation therapy is the standard treatment for unresectable, locally advanced NSCLC, but its efficacy reaches a platform, and treatment-related life threatening toxicity limits its use. The EGFR tyrosine kinase inhibitors (TKIs) produce a dramatic response in patients carrying EGFR activating mutations in the metastatic setting. Multiple prospective trials show that EGFR-TKIs have a better tolerability when compared with chemotherapy.

Conditions

• Non-small Cell Lung Cancer
• Epidermal Growth Factor Receptor

Interventions

Type	Name	Description
DRUG	Erlotinib Hydrochloride	Subjects receive erlotinib tablet 150mg orally once daily, after 12 weeks of induction phase, local radiotherapy is intercalated, and followed by 24-week erlotinib maintenance phase. At the end of maintenance, the subjects enter into the follow-up period.

Timeline

• Start date: 2017-02-27
• Primary completion: 2019-06-30
• Completion: 2020-06-30
• First posted: 2017-03-09
• Last updated: 2017-03-09

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study