Intercalating and Maintenance Use of Iressa vs. Chemotherapy in Selected Advanced NSCLC: a Randomised Study
18 Years
75 Years
Both
Non-small Cell Lung Cancer
Trial Information
Intercalating and Maintenance Use of Iressa vs. Chemotherapy in Selected Advanced NSCLC: a Randomised Study
Nowadays,EGFR mutation status is unknown for most of the advanced NSCLC patients in
clinical practice.Those patients with high probability of EGFR mutation maybe could get
benefit from gefitinib as first-line treatment. For this reason, the investigators need more
investigation to focus on EGFR mutation unknown patients. In the previous study (including
FAST-ACT), the patients enrolled trial received EGFR-TKI plus chemotherapy nearly
simultaneously,so the investigators could not know whether those patients gained benefit
from EGFR-TKI or chemotherapy, maybe chemotherapy alone was enough. If the patients with
EGFR mutation status unknown could get stable disease(SD) after two cycles of
chemotherapy,those patients may be optimal for the investigation of intercalating and
maintenance administration of gefitinib. The reasons are that chemotherapy may be enough
for those with objective response after two cycles chemotherapy, of course, those with
disease progression (PD) should be excluded from the study.
On the basis of these and other studies, the investigators hypothesized that in a selected
population,first-line chemotherapy(gemcitabine +carboplatin) with intercalating and
maintenance use of gefitinib would be more efficacious than chemotherapy alone. In this
study, the investigators compared the efficacy, safety, and adverse-event profile of
chemotherapy plus gefitinib with those of chemotherapy alone, when these drugs were used as
first-line treatment in nonsmokers or former light smokers in China, who had lung
adenocarcinoma with EGFR gene mutation unknown.
Inclusion Criteria:
- After two cycles chemotherapy(gemcitabine plus carboplatin), patients with stable
disease(SD) by RECIST1.1.
- Patients between 18 and 75 years of age.
- Present with histologically proven or cytological diagnosis of adenocarcinoma NSCLC
Stage IIIB or IV as defined by the American Joint Committee on Cancer Staging
Criteria for Lung Cancer, that is not amenable to curative therapy,such as surgery or
radiotherapy and so on.
- No prior systemic chemotherapy or targeted therapy for lung cancer before screening.
- Never smokers(defined as having smoked less than 100 cigarettes in their lifetime )
or light ex-smokers (defined as having ceased smoking at least 15 years before Day 1
of study treatment and having smoked 10 pack-years or fewer).
- EGFR mutation status unknown.
- ECOG performance status of 0 or 1.
- Adequate organ function.
- Prior radiation therapy allowed to <25% of the bone marrow . Prior radiation to the
whole pelvis is not allowed. Prior radiotherapy must be completed at least 4 weeks
before study enrollment. Patients must have recovered from the acute toxic effects
of the treatment prior to study enrollment.
- Signed informed consent document on file.
- Estimated life expectancy of ≥12 weeks.
- Patient compliance and geographic proximity that allow adequate follow up.
Exclusion Criteria:
- Known severe hypersensitivity to gefitinib.
- Patients with brain metastasis.
- Pleural effusion or pericardiac effusion that cannot be controlled by drainage or
other procedures.
- Inability to comply with protocol or study procedures.
- A serious concomitant systemic disorder that, in the opinion of the investigator,
would compromise the patient's ability to complete the study.
- A serious cardiac condition, such as myocardial infarction within 6 months, angina,
or heart disease.
- Second primary malignancy that is clinically detectable at the time of consideration
for study enrollment.
- Interstitial pneumonia.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
RECIST1.1
Outcome Description:
Patients were imaged with computed tomography (CT) scan.
Outcome Time Frame:
eight weeks
Safety Issue:
Yes
Principal Investigator
Yilong Wu, MD.
Investigator Role:
Study Chair
Investigator Affiliation:
Guangdong Province Clinical Trial Association
Authority:
China: Food and Drug Administration
Study ID:
CTONG 1102
NCT ID:
NCT01404260
Start Date:
June 2011
Completion Date:
April 2014
Related Keywords:
- Non-Small Cell Lung Cancer
- chemotherapy
- maintenance therapy
- gefitinib
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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