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

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ClinicalTrials.gov Identifier: NCT02103257
Recruitment Status : Unknown
Verified April 2015 by Betta Pharmaceuticals Co., Ltd..
Recruitment status was:  Recruiting
First Posted : April 3, 2014
Last Update Posted : April 29, 2015
Sponsor:
Information provided by (Responsible Party):
Betta Pharmaceuticals Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
EGFR Positive Non-small Cell Lung Cancer Adenocarcinoma Drug: Sequential Icotinib Plus Chemotherapy Drug: Icotinib Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sequential Icotinib Plus Chemotherapy Versus Icotinib Alone as First-line Treatment in Stage IIIB/IV Lung Adenocarcinoma: a Randomized, Open-label, Multicenter Study
Study Start Date : March 2014
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


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:
  • Comana
  • BPI-2009




Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 15 months ]
    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.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 24 months ]
    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.

  2. Objective response rate [ Time Frame: 15 months ]
    Number of subjects with confirmed objective response according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

  3. Adverse events [ Time Frame: 24 months ]
    The number of patients who suffered adverse events, which is graded by NCI CTCAE version 4.0.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02103257


Contacts
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Contact: Helong Zhang, MD 13709202616

Locations
Show Show 31 study locations
Sponsors and Collaborators
Betta Pharmaceuticals Co., Ltd.
Investigators
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Principal Investigator: Helong Zhang, MD Tang-Du Hospital
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Responsible Party: Betta Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT02103257    
Other Study ID Numbers: BD-IC-IV62
First Posted: April 3, 2014    Key Record Dates
Last Update Posted: April 29, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Adenocarcinoma
Adenocarcinoma of Lung
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type