Phase II Study of Erlotinib With Concurrent Radiotherapy in Unresectable NSCLC With Activating Mutation of EGFR in Exon 19 or 21

Study Overview
=================
Brief Summary
-----------------
Erlotinib with concurrent radiotherapy has superior efficacy and comparable safety profile in unresectable stage III non-small cell lung cancer (NSCLC) patients with activating mutation of epidermal growth factor receptor (EGFR) in exon 19 or 21 versus etoposide plus cis-platin with concurrent radiotherapy.

Official Title
-----------------
A Multicenter, Randomized, Open-label, Phase II Study to Evaluate the Efficacy and Safety of Erlotinib Versus Etoposide Plus Cisplatin With Concurrent Radiotherapy in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) With Activating Mutation of Epidermal Growth Factor Receptor (EGFR) in Exon 19 or 21

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Other: Erlotinib w Concurrent Radiotherapy
* Other: etoposide/cis-platin (EP) w Concurrent Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NSCLC confirmed by histopathology or cytology; Stage IIA or IIIB NSCLC according to Tumor Node Metastasis (TMN) staging of Lung Staging Standard version 7 2009, and be unresectable; Has active mutation of EGFR in exon 19 or 21; Has measurable lesion [according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, must have at least one evaluable lesion with the longest dimension >= 10mm; if the evaluable lesion is lymph node, the shortest dimension should be measured and >=15mm]; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1; expectancy life >= 12 weeks; Exclusion Criteria: Had be treated by HER-targeting agents; Had systemic anit-NSCLC treatments; Had local radiotherapy for NSCLC; Has upper gastrointestinal physiological disorders, or malabsorption syndrome, or intolerance of oral medication, or active peptic ulcer; Diagnosed other malignant tumor besides NSCLC within 5 years prior the study treatment (except having simple surgical resection with 5-year disease free survival, cured in situ of cervical carcinoma, cured basal cell carcinoma and bladder epithelial tumor); Any evidence to indicate moderate or severe chronic obstructive pulmonary disease (COPD); Known hypersensitivity to platinum, etoposide, EGFR-Tyrosine Kinase Inhibitor (TKI) agents or relevant components in the formulation; Uncontrolled eye inflammation or infection, or any potential circumstances lead to eye inflammation or infection;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erlotinib w Concurrent Radiotherapy<br>erlotinib 150mg oral daily up to 2 years concurrent radiotherapy total dose 60-66 Gray (Gy) in 2 Gray (Gy) fractions. One fraction per day, and 5 fractions per week. | Other: Erlotinib w Concurrent Radiotherapy<br> <br> |
| Active Comparator: etoposide/cis-platin (EP) w Concurrent Radiotherapy<br>etoposide 50mg/m2 on D1-5 and D29-33 cis-platin 50mg/m2 on D1, D8, D29 and D36 concurrent radiotherapy total 60-66 Gray (Gy) in 2 Gray (Gy) fractions. One fraction per day, 5 fractions per week. | Other: etoposide/cis-platin (EP) w Concurrent Radiotherapy<br>* Etoposide / Cis-platin w Concurrent Radiotherapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress Free Survival (PFS) | The time frame from the randomization to the first confirmed disease progression or any cause to death (dependent on which comes first) | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NSCLC, EGFR mutation, unresectable, erlotinib, concurrent radiotherapy