Erlotinib Combined With Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer (LA-NSCLC)

Phase 2

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Erlotinib; Radiation: Thoracic radiotherapy

• Registration Number: NCT01091376
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

Concomitant chemoradiotherapy is the standard treatment of locally advanced,non-resectable, non-small cell lung cancer (NSCLC). However,the optimal chemotherapy regimen is still controversial.The objective of this study was to evaluate the efficacy and toxicity of a concomitant treatment using Erlotinib and radiotherapy followed by Erlotinib consolidation treatment.

Detailed Description

Patients with non-resectable Non-small Cell Lung Cancer will receive thoracic radiation therapy 60-70 Gy over 30-35 fractions and concurrent with Erlotinib 150mg/day. Followed by Erlotinib 150 mg/day consolidation treatment.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-14
• Status Verified: 2010-03
• Study First Submitted QC: 2010-03-21
• Study First Posted: 2010-03-24
• Last Update Submitted: 2010-05-13
• Last Update Posted: 2010-05-17
• Primary Completion: 2010-12
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Histologically proven non-small cell lung cancer (squamous cell carcinoma, adenocarcinoma, large cell carcinoma and etc)
• Tumor EGFR mutation
• Presence of measurable disease by RECIST
• stage IIIA or IIIB, non-resectable
• ECOG performance status 0-2
• No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy
• Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital.

Exclusion Criteria

• Carcinoid tumor, small cell carcinoma of lung
• Patients with any distant metastasis
• History of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
• Any other morbidity or situation with contraindication for radiotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment)
• Pregnant or lactating women, women who has not taken test of pregnancy (within 7 days before the first administration) and pregnant women
• Women and men of childbearing potential who have no willing of employing adequate contraception
• Tumor EGFR wild

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Concomitant Erlotinib and radiotherapy	Thoracic radiotherapy	Patients received Erlotinib and radiation therapy.
Concomitant Erlotinib and radiotherapy	Erlotinib	Patients received Erlotinib and radiation therapy.

Primary Outcome Measures

Name	Time	Method
Tumor response rate (Response was analyzed according to the RECIST system, based on CT scans.)	After the thoracic radiotherapy and concurrent Erlotinib treatment
The safety (The safety was evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0.)	Every one month

Secondary Outcome Measures

Name	Time	Method
Progression free survival	The time from the start of treatment to diease progression
The overall survival	The time from the start of treatment to death
Quality of Life (QoL was evaluated according to the FACT-L.)	Every one month

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China