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A Phase II Randomised, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Icotinib in Combination With Chemotherapy Versus Chemotherapy Alone in Patients Who Have Progressed After Icotinib Treatment in NSCLC


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

A Phase II Randomised, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Icotinib in Combination With Chemotherapy Versus Chemotherapy Alone in Patients Who Have Progressed After Icotinib Treatment in NSCLC


Inclusion Criteria:



- Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients
confirmed by sputum cytology)

- No previous targeted treatment such as gefitinib, erlotinib.

- With a measurable disease(longest diameters >=10mm with Spiral computed tomography
(CT)and >=20mm with conventional CT) according to RECIST Criteria

- WHO performance status(PS)<= 2

- N>=1.5×109/L, Plt>=1.0×109/L,Hb>=10g/dL;AST&ALT should <3ULN(without liver
metastasis) or <5ULN(with liver metastasis).TBIL<=1.5ULN.

- Signed and dated informed consent before the start of specific protocol procedures.

Exclusion Criteria:

- Allergic to icotinib

- Patients with metastatic brain tumors with symptoms.

- Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or
small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab.

- Severe systemic disease out of control such as unstable or uncompensated
respiratory,cardiac,liver,renal diseases.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

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:

6 months

Safety Issue:

No

Principal Investigator

Zhang Yi Ping, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Zhejiang Cancer Hospital

Authority:

China: Food and Drug Administration

Study ID:

BD-IC-IV44

NCT ID:

NCT01707329

Start Date:

September 2012

Completion Date:

September 2014

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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