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

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

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.

Study Overview

• Status: Unknown
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Other: Erlotinib w Concurrent Radiotherapy; Other: etoposide/cis-platin (EP) w Concurrent Radiotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital
    • Beijing, Beijing, China, 100853
      • The General Hospital of the People's Liberation Army
    • Beijing, Beijing, China, 100853
      • Chinese PLA General Hospital
    • Beijing, Beijing, China, 100021
      • Cancer Institute & Hospital, Chinese Academy of Medical Sciences
  • Fujian
    • Fuzhou, Fujian, China, 350008
      • Fujian Province Cancer Hospital
    • Xiamen, Fujian, China, 361003
      • The First Affiliated Hospital of Xiamen University
  • Guizhou
    • Guiyang, Guizhou, China, 550004
      • Guizhou Cancer Hospital
  • Hebei
    • Shijiazhuang, Hebei, China, 050011
      • Hebei Medical University Fourth Hospital
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    • Wuhan, Hubei, China, 430030
      • Zhongnan Hospital of Wuhan University
    • Wuhan, Hubei, China, 430060
      • Renmin Hospital of Wuhan University
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • The First Hospital of China Medical University
  • Shandong
    • Jinan, Shandong, China, 250117
      • Shandong Cancer Hospital and Institute
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Fudan University Shanghai Cancer Center
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, West China School of Medicine, Sichuan University
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Tianjin Medical University Cancer Institute and Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310006
      • The First People's Hospital of Hangzhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Erlotinib w Concurrent Radiotherapy; 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
Active Comparator: etoposide/cis-platin (EP) w Concurrent Radiotherapy; 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; Etoposide / Cis-platin w Concurrent Radiotherapy

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

Collaborators and Investigators

• Sponsor: Jinming Yu
• Collaborators: Roche Pharma AG
• Investigators: Study Chair: Jinming Yu, PhD, Shandong Cancer Hospital and Institute; Principal Investigator: Shenglin Ma, PhD, The First People's Hospital of Hangzhou; Principal Investigator: Conghua Xie, PhD, Wuhan University; Principal Investigator: Ming Chen, PHD, Zhejiang Cancer Hospital; Principal Investigator: Gang Wu, PhD, Tongji Medical College, Huazhong University of Science and Technology, Wuhan Union Hospital; Principal Investigator: Jianhua Wang, PhD, Henan Cancer Hospital; Principal Investigator: Jiancheng Li, PhD, Fujian Province Cancer Hospital; Principal Investigator: Zhengfei Zhu, PhD, Fudan University; Principal Investigator: You Lu, PhD, West China Hospital, West China School of Medicine, Sichuan University; Principal Investigator: Lvhua Wang, PhD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Principal Investigator: Guangying Zhu, PhD, Peking University Cancer Hospital & Institute; Principal Investigator: Tingyi Xia, PhD, Chinese PLA General Hospital; Principal Investigator: Chun Han, PhD, Hebei Medical University Fourth Hospital; Principal Investigator: Guang Li, PhD, First Hospital of China Medical University; Principal Investigator: Zhiyong Yuan, PhD, Tianjin Medical University Cancer Institute and Hospital; Principal Investigator: Qin Lin, PhD, The First Affiliated Hospital of Xiamen University; Principal Investigator: Qibin Song, PhD, Renmin Hospital of Wuhan University; Principal Investigator: Yaping Xu, PhD, Zhejiang Cancer Hospital; Principal Investigator: Bing Lu, PhD, Cancer Hospital of Guizhou Province; Principal Investigator: Baolin Qu, PhD, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2012
• Primary Completion (Anticipated): August 20, 2018
• Study Completion (Anticipated): October 20, 2018

Study Registration Dates

• First Submitted: October 23, 2012
• First Submitted That Met QC Criteria: October 25, 2012
• First Posted (Estimate): October 26, 2012

Study Record Updates

• Last Update Posted (Estimate): February 7, 2017
• Last Update Submitted That Met QC Criteria: February 4, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: NSCLC; erlotinib; unresectable; EGFR mutation; concurrent radiotherapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Protein Kinase Inhibitors; Etoposide; Erlotinib Hydrochloride; Cisplatin
• Other Study ID Numbers: ML28545