Erlotinib Combined With Radiotherapy in Patients With Non-resectable Locally Advanced Non-small Cell Lung Cancer (LA-NSCLC) (RT0901)

University of Chinese Academy Sciences

Status and phase: Unknown; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Erlotinib; Radiation: Thoracic radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01091376

ZhejiangCH02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Concomitant Erlotinib and radiotherapy

Experimental group

Description:

Patients received Erlotinib and radiation therapy.

Treatment:

Radiation: Thoracic radiotherapy

Drug: Erlotinib