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

NCT00455936 | Completed Phase 3

• 2 other identifiers: NCCCTS-05-126D7913L00054
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 3

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.

Conditions

Lung Cancer

Keywords

Adenocarcinoma; NSCLC; gemcitabine; Cisplatin; Gefitinib; Never smoker

Outcome Measures

Primary Outcomes (1)

• overall survival

  every 12 weeks

Secondary Outcomes (5)

• To compare Progression-Free survival

  every 9 weeks

• To compare the quality of life

  every 3 weeks

• To compare safety profile

  every 9 weeks

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

  screening period

• To compare the objective response rate (CR+PR)

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

Study Arms (2)

study arm

EXPERIMENTAL

Gefitinib 250mg table/QD, daily every 3 weeks

Drug: Gefitinib

control arm

ACTIVE COMPARATOR

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

Procedure: chemotherapy

Interventions

Gefitinib DRUG

gefitinib 250mg tablet/ QD daily until Progression

Also known as: Treamtment Arm

study arm

chemotherapy PROCEDURE

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

Also known as: standard chemotherapy arm

control arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Center, Korea: lead
• AstraZeneca: collaborator

Study Sites (3)

National Cancer Center, Korea

Goyang-si, Gyenggi-do, 411-769, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (1)

• 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.

  PMID: 22772951 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Adenocarcinoma

Interventions

Gefitinib; Drug Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Jin Soo Lee, M.D.

  National Cancer Center, Korea

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: April 3, 2007
• First Posted: April 4, 2007
• Study Start: October 1, 2005
• Primary Completion: November 1, 2009
• Study Completion: March 1, 2010
• Last Updated: October 25, 2010

Record last verified: 2010-03

Locations

KR (3)