Conmana Versus Pemetrexed-based First-line Induction and Maintenance Chemotherapy in Advanced Lung Adenocarcinoma With EGFR-mutation
18 Years
75 Years
Both
NSCLC
Trial Information
Conmana Versus Pemetrexed-based First-line Induction and Maintenance Chemotherapy in Advanced Lung Adenocarcinoma With EGFR-mutation
This study is designed to evaluate the efficacy and safety of icotinib and pemetrexed-based
first-line induction and maintenance chemotherapy in advanced lung adenocarcinoma with
EGFR-mutation，primary endpoint is progress-free survival，second endpoints include overall
survival, time to progression, and so on.
Inclusion Criteria:
- Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients.
- Positive EGFR Mutation.
- No previous systemic anticancer therapy.
- Measurable lesion according to RECIST with at least one measurable lesion not
previously irradiated, unless disease progression has been documented at that site.
- Provision of written informed consent.
Exclusion Criteria:
- Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or
small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab.
- Evidence of clinically active Interstitial Lung Diseases (Patients with chronic,
stable, radiographic changes who are asymptomatic need not be excluded).
- Known severe hypersensitivity to icotinib or any of the excipients of this product.
- Evidence of any other significant clinical disorder or laboratory finding that makes
it undesirable for the subject to participate in the study.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression Free Survival
Outcome Description:
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.
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
Shi Yuankai, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cancer Hospital, Chinese Academy of Medical Sciences
Authority:
China: Food and Drug Administration
Study ID:
BD-IC-IV36
NCT ID:
NCT01719536
Start Date:
October 2012
Completion Date:
October 2014
Related Keywords:
- NSCLC
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Lung Neoplasms
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