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Conmana Versus Pemetrexed-based First-line Induction and Maintenance Chemotherapy in Advanced Lung Adenocarcinoma With EGFR-mutation


Phase 3
18 Years
75 Years
Open (Enrolling)
Both
NSCLC

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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´╝îprimary endpoint is progress-free survival´╝îsecond 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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