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First-line Gefitinib Versus Chemotherapy for Lung Adenocarcinoma in Never Smoker

Primary Purpose

Lung Cancer

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Gefitinib

chemotherapy

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Adenocarcinoma, NSCLC, gemcitabine, Cisplatin, Gefitinib, Never smoker

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically or cytologically confirmed diagnosis of adenocarcinoma of lung with or without BAC features; however, adenocarcinoma combined with other histology, such as small cell carcinoma or squamous carcinoma, is not allowed.
Stage IIIB with malignant pleural effusion/pleural seeding or stage IV patients
Age 18-75
Never-smoking defined as not more than 100 cigarettes during the lifetime
ECOG performance status of 0-2
No prior invasive malignancies 5 years prior to study entry except adequately treated cutaneous basal cell carcinoma or uterine cervix in situ cancer
Serum creatinine ≤ 1.5 mg/dL, serum bilirubin ≤ 1.2 mg/dL (1 x UNL) and SGOT/SGPT ≤ 100 IU/L (2.5 x UNL)
Serum Hgb ≥ 10 gm/dl, platelet count ≥ 100,000/ul, total WBC count >= 4,000/uL, absolute neutrophil count ≥ 1,500/ul
Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital. The only approved consent form is attached to this protocol
The presence of CNS metastases is not considered as an exclusion criterion, provided that there is good control of the symptoms with corticosteroids

Exclusion Criteria:

Pregnancy or breast-feeding (women of child-bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy.
Major surgery other than biopsy within the past two week.
Known severe hypersensitivity to Gefitinib or any of the excipients of this product
Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort
Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.

Sites / Locations

National Cancer Center, Korea
Samsung Medical Center
Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

study arm

control arm

Arm Description

Gefitinib 250mg table/QD, daily every 3 weeks

gemcitabine 1250mg/m2 iv on D1 & D8 every 3 weeks Cisplatin 80mg/m2 iv on D1 every 3 weeks

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

To compare Progression-Free survival

To compare the quality of life

To compare safety profile

To collect the tissue samples for the study of predictors of gefitinib (optional)

To compare the objective response rate (CR+PR)

Full Information

NCT ID

NCT00455936

First Posted

April 3, 2007

Last Updated

October 22, 2010

Sponsor

National Cancer Center, Korea

Collaborators

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00455936

Brief Title

First-line Gefitinib Versus Chemotherapy for Lung Adenocarcinoma in Never Smoker

Official Title

A Randomized Phase III Study of Gefitinib (IRESSATM) Versus Standard Chemotherapy (Gemcitabine Plus Cisplatin) as First-line Treatment for in Never Smokers Advance or Metastatic Adenocarcinoma of Lung

Study Type

Interventional

2. Study Status

Record Verification Date

March 2010

Overall Recruitment Status

Completed

Study Start Date

October 2005 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

National Cancer Center, Korea

Collaborators

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The investigators will conduct the randomized trial to determine the role of Gefitinib monotherapy as first-line setting in adenocarcinoma patients with no history of smoking, as compared with the standard combination chemotherapy. This is a randomized, open label, parallel group, phase III study in never-smokers with advanced or metastatic adenocarcinoma of lung. After stratification by gender, performance status, and disease stage, patients will be randomized to one of the two treatment arms to receive either gefitinib or standard chemotherapy until clinical or objective disease progression, unacceptable toxicity or patient's refusal, whichever is sooner. The chemotherapy will be administered for no more than nine cycles.

Detailed Description

Gefitinib (Iressa TM) Arm - Gefitinib administration 250mg tablet once daily every 3 weeks standard chemotherapy arm - gemcitabine (1,250mg/m2 for 30 minutes on day 1 and 8 of a 3 week cycle) plus cisplatin (80mg/m2 on day 1 of a 3 week cycle)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

Adenocarcinoma, NSCLC, gemcitabine, Cisplatin, Gefitinib, Never smoker

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

315 (Actual)

8. Arms, Groups, and Interventions

Arm Title

study arm

Arm Type

Experimental

Arm Description

Gefitinib 250mg table/QD, daily every 3 weeks

Arm Title

control arm

Arm Type

Active Comparator

Arm Description

gemcitabine 1250mg/m2 iv on D1 & D8 every 3 weeks Cisplatin 80mg/m2 iv on D1 every 3 weeks

Intervention Type

Drug

Intervention Name(s)

Gefitinib

Other Intervention Name(s)

Treamtment Arm

Intervention Description

gefitinib 250mg tablet/ QD daily until Progression

Intervention Type

Procedure

Intervention Name(s)

chemotherapy

Other Intervention Name(s)

standard chemotherapy arm

Intervention Description

gemcitabine(1250mg/m2 iv on D1 & 8) plus Cisplatin (80mg/m2 iv on D1) every 3 weeks, maximum 9 cycles

Primary Outcome Measure Information:

Title

overall survival

Time Frame

every 12 weeks

Secondary Outcome Measure Information:

Title

To compare Progression-Free survival

Time Frame

every 9 weeks

Title

To compare the quality of life

Time Frame

every 3 weeks

Title

To compare safety profile

Time Frame

every 9 weeks

Title

To collect the tissue samples for the study of predictors of gefitinib (optional)

Time Frame

screening period

Title

To compare the objective response rate (CR+PR)

Time Frame

from the date of randomization to the date of death from any cause the result of each should be recorded separately

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically or cytologically confirmed diagnosis of adenocarcinoma of lung with or without BAC features; however, adenocarcinoma combined with other histology, such as small cell carcinoma or squamous carcinoma, is not allowed. Stage IIIB with malignant pleural effusion/pleural seeding or stage IV patients Age 18-75 Never-smoking defined as not more than 100 cigarettes during the lifetime ECOG performance status of 0-2 No prior invasive malignancies 5 years prior to study entry except adequately treated cutaneous basal cell carcinoma or uterine cervix in situ cancer Serum creatinine ≤ 1.5 mg/dL, serum bilirubin ≤ 1.2 mg/dL (1 x UNL) and SGOT/SGPT ≤ 100 IU/L (2.5 x UNL) Serum Hgb ≥ 10 gm/dl, platelet count ≥ 100,000/ul, total WBC count >= 4,000/uL, absolute neutrophil count ≥ 1,500/ul Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital. The only approved consent form is attached to this protocol The presence of CNS metastases is not considered as an exclusion criterion, provided that there is good control of the symptoms with corticosteroids Exclusion Criteria: Pregnancy or breast-feeding (women of child-bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy. Major surgery other than biopsy within the past two week. Known severe hypersensitivity to Gefitinib or any of the excipients of this product Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded) As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jin Soo Lee, M.D.

Organizational Affiliation

National Cancer Center, Korea

Official's Role

Study Chair

Facility Information:

Facility Name

National Cancer Center, Korea

City

Goyang-si

State/Province

Gyenggi-do

ZIP/Postal Code

411-769

Country

Korea, Republic of

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

Asan Medical Center

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

22772951

Citation

Lee Y, Kim SH, Han JY, Kim HT, Yun T, Lee JS. Early neutrophil-to-lymphocyte ratio reduction as a surrogate marker of prognosis in never smokers with advanced lung adenocarcinoma receiving gefitinib or standard chemotherapy as first-line therapy. J Cancer Res Clin Oncol. 2012 Dec;138(12):2009-16. doi: 10.1007/s00432-012-1281-4. Epub 2012 Jul 7.

Results Reference

derived

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First-line Gefitinib Versus Chemotherapy for Lung Adenocarcinoma in Never Smoker

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