Sequential Icotinib Plus Chemotherapy Versus Icotinib Alone as First-line Treatment in Stage IIIB/IV Lung Adenocarcinoma

Sequential Icotinib Plus Chemotherapy Versus Icotinib Alone as First-line Treatment in Stage IIIB/IV Lung Adenocarcinoma: a Randomized, Open-label, Multicenter Study

This randomised, controlled, multicentre trial is designed to assess the efficacy and safety of sequential icotinib plus chemotherapy versus single icotinib as first-line treatment in stage IIIB/IV lung adenocarcinoma patients with EGFR mutation.

Study Overview

• Status: Unknown
• Conditions: Adenocarcinoma; EGFR Positive Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Sequential Icotinib Plus Chemotherapy; Drug: Icotinib

• Study Type: Interventional
• Enrollment (Anticipated): 192
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • Active, not recruiting
      • First Hospital of Lanzhou University
    • Lanzhou, Gansu, China, 730050
      • Active, not recruiting
      • Lanzhou Military Region General Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510010
      • Active, not recruiting
      • General Hospital of Guangzhou Military Command
    • Guangzhou, Guangdong, China, 510060
      • Active, not recruiting
      • Cancer Hospital of Sun Yat-sen
    • Guangzhou, Guangdong, China, 510120
      • Active, not recruiting
      • First Affiliated Hospital of Guangzhou Medical College
    • Jiangmen, Guangdong, China, 529030
      • Active, not recruiting
      • Jiangmen Central Hospital
    • Shenzhen, Guangdong, China, 518000
      • Active, not recruiting
      • The University of Hong Kong-Shenzhen Hospital
    • Shenzhen, Guangdong, China, 518020
      • Active, not recruiting
      • Shenzhen People's Hospital
    • Shenzhen, Guangdong, China, 518035
      • Active, not recruiting
      • Medical Oncology,Shenzhen Second People's Hospital
    • Shenzhen, Guangdong, China, 518035
      • Active, not recruiting
      • Thoracic Surgery,Shenzhen Second People's Hospital
    • Shenzhen, Guangdong, China, 518036
      • Active, not recruiting
      • Peking University Shenzhen Hospital
    • Zhanjiang, Guangdong, China, 524009
      • Active, not recruiting
      • Guangdong Agribusiness Center Hospital
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Active, not recruiting
      • First Affiliated Hospital of Guangxi Medical University
  • Hainan
    • Haikou, Hainan, China, 570311
      • Active, not recruiting
      • Hainan Provincal Nong Ken Hospital
    • Haikou, Hainan, China, 570311
      • Active, not recruiting
      • Hainan Provincial People's Hospital
  • Henan
    • Zhengzhou, Henan, China, 450052
      • Active, not recruiting
      • First Affiliated Hospital of Zhengzhou University
  • Ningxia
    • Yinchuan, Ningxia, China, 750004
      • Active, not recruiting
      • Medical Oncology，General Hospital of Ningxia Medical University
    • Yinchuan, Ningxia, China, 750004
      • Active, not recruiting
      • Radiation Oncology，General Hospital of Ningxia Medical University
    • Yinchuan, Ningxia, China, 750004
      • Active, not recruiting
      • Respiratory medicine，General Hospital of Ningxia Medical University
  • Shanxi
    • Baoji, Shanxi, China, 721008
      • Active, not recruiting
      • Baoji Central Hospital
    • Hanzhong, Shanxi, China, 723000
      • Active, not recruiting
      • 3201 Hospital, Hanzhong, Shanxi
    • Xi'an, Shanxi, China, 710000
      • Active, not recruiting
      • ShaanXi Province People's Hospital
    • Xi'an, Shanxi, China, 710004
      • Active, not recruiting
      • Second Affiliated Hospital of Xi'an JiaoTong University
    • Xi'an, Shanxi, China, 710018
      • Active, not recruiting
      • Xi'an Chang'an Hospital
    • Xi'an, Shanxi, China, 710038
      • Recruiting
      • Tangdu hospital,fourth military medical university
      • Contact: Helong Zhang, MD; Phone Number: 13709202616
      • Principal Investigator: Helong Zhang, MD
    • Xi'an, Shanxi, China, 710061
      • Active, not recruiting
      • First Affiliated Hospital of Xi'an JiaoTong University
    • Xi'an, Shanxi, China, 710061
      • Active, not recruiting
      • Shanxi Cancer Hospital
  • Xinjiang
    • Urumqi, Xinjiang, China, 830000
      • Active, not recruiting
      • Urumqi General Hospital of Lanzhou Military Region General Hospital
    • Urumqi, Xinjiang, China, 830000
      • Active, not recruiting
      • Xinjiang Medical University Affiliated Tumor Hospital
    • Urumqi, Xinjiang, China, 830054
      • Active, not recruiting
      • First Affiliated Hospital of Xinjiang Medical University
    • Urumqi, Xinjiang, China, 830099
      • Active, not recruiting
      • Autonome Region Xinjiang Uygur Chinese medicine hospital

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:

• Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT)
• Patients must have previously untreated locally advanced or metastatic NSCLC
• EGFR activating mutation (exon 19 deletion, L858R) is required
• Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1

Exclusion Criteria:

• Prior chemotherapy or treatment with gefitinib, erlotinib, or other drugs that target EGFR
• Patients with wild-type EGFR
• Any other investigational agents are not permitted
• Any evidence of interstitial lung disease

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: Sequential icotinib plus chemotherapy; Sequential icotinib plus chemotherapy : pemetrexed 500mg/m2 iv d1, cisplatin 75mg/m2 d1, icotinib 125 mg is administered orally three times per day d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4 cycles treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity.	Drug: Sequential Icotinib Plus Chemotherapy; Sequential icotinib plus chemotherapy: pemetrexed 500mg/m2 iv d1, cisplatin 75mg/m2 d1, icotinib 125 mg is administered orally three times per day d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4 cycles treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity.; Other Names: ALIMTA; DDP; Comana, BPI-2009
Active Comparator: Icotinib; Icotinib 125 mg is administered orally three times per day until disease progression or intolerable toxicity.	Drug: Icotinib; Icotinib 125 mg is administered orally three times per day until disease progression or intolerable toxicity.; Other Names: BPI-2009; Comana

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival	A duration from randomization date to disease progression(as defined by RECIST) or death. If a participant are known to have progressed, the time to progression is defined as the time from the date of randomization to the date of progression. Otherwise, a participant will be censored at the last date they are known not to be progressed.	15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall Survival is assessed via calculation of the time to death due to any cause. If a participant is known to have died, the time to death is defined as the time from the date of randomization to the date of death. Otherwise, a participant will be censored at the last date they are known to be alive.	24 months
Objective response rate	Number of subjects with confirmed objective response according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.	15 months
Adverse events	The number of patients who suffered adverse events, which is graded by NCI CTCAE version 4.0.	24 months

Collaborators and Investigators

• Sponsor: Betta Pharmaceuticals Co., Ltd.
• Investigators: Principal Investigator: Helong Zhang, MD, Tang-Du Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): March 1, 2016
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: March 31, 2014
• First Submitted That Met QC Criteria: March 31, 2014
• First Posted (Estimate): April 3, 2014

Study Record Updates

• Last Update Posted (Estimate): April 29, 2015
• Last Update Submitted That Met QC Criteria: April 27, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Adenocarcinoma; Adenocarcinoma of Lung
• Other Study ID Numbers: BD-IC-IV62