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Multicenter Phase II Trial of Gefitinib (Iressa™) First Line Therapy Followed by Chemotherapy in Advanced Non-Small Cell Lung Cancer (NSCLC)

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Multicenter Phase II Trial of Gefitinib (Iressa™) First Line Therapy Followed by Chemotherapy in Advanced Non-Small Cell Lung Cancer (NSCLC)



- Determine the efficacy of gefitinib as first-line therapy, in terms of response rate
(complete and partial response) or stability of disease, in patients with de novo or
recurrent stage IIIB or IV non-small cell lung cancer.


- Determine the safety of this drug in these patients.

- Determine the efficacy of gemcitabine combined with cisplatin when administered after
first-line gefitinib in these patients.

- Determine quality of life of patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral gefitinib once daily until disease progression or unacceptable
toxicity. Within 3 weeks after documented disease progression, patients receive gemcitabine
IV over 30 minutes on days 1 and 8 followed by cisplatin IV over 1 hour on day 1. Treatment
repeats every 21 days for 6 courses in the absence of disease progression or unacceptable

Quality of life is assessed at baseline, weeks 3, 6, 12, 18, and then every 12 weeks
thereafter during gefitinib treatment. During chemotherapy, quality of life is assessed 1
week prior to starting chemotherapy treatment, day 1 of courses 3 and 5, and then every 12
weeks until disease progression.

After completion of study therapy, patients are followed every 3 months.

PROJECTED ACCRUAL: `A total of 24-63 patients will be accrued for this study.

Inclusion Criteria


- Histologically* or cytologically* confirmed non-small cell lung cancer (NSCLC),
including any of the following cellular subtypes:

- Squamous cell carcinoma

- Adenocarcinoma

- Large cell carcinoma

- Poorly differentiated NSCLC NOTE: *New biopsies or cytologic specimens required
for primary resection specimens older than 2 years

- De novo or recurrent disease, meeting 1 of the following stage criteria:

- Stage IIIB disease

- Malignant pleural effusion OR supraclavicular node involvement (N3)

- Not suitable for curative multimodal treatment or surgery

- Stage IV disease

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional techniques OR ≥ 10 mm by spiral CT scan or MRI

- Measurable lesion must be outside previously irradiated areas

- Immediate chemotherapy is not clinically mandatory

- No small cell lung cancer (SCLC) or SCLC combined with NSCLC

- No symptomatic and/or untreated brain metastases



- 18 and over

Performance status

- WHO 0-1

Life expectancy

- Not specified


- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 10.0 g/dL


- Bilirubin normal

- AST or ALT ≤ 2.5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN in the presence of bone metastases)

- No unstable or uncompensated hepatic disease


- Creatinine clearance > 60 mL/min

- No unstable or uncompensated renal disease


- No unstable or uncompensated cardiac disease

- No myocardial infarction within the past 3 months


- No clinically active interstitial lung disease

- Asymptomatic patients with chronic stable radiographic changes allowed

- No unstable or uncompensated respiratory disease


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 12 months after
completion of study treatment

- Able to swallow and retain oral medication

- No active infection

- No uncontrolled diabetes mellitus

- No history of allergic reactions or hypersensitivity attributed to compounds of
similar chemical or biological composition to study drugs

- No other severe or uncontrolled systemic disease

- No other serious underlying medical condition that would preclude study participation

- No psychiatric disability that would preclude study compliance or giving informed

- No other malignancy within the past 5 years except adequately treated nonmelanoma
skin cancer or carcinoma in situ of the cervix


Biologic therapy

- Not specified


- Prior intrapleural or intrapericardial local chemotherapy allowed

- No prior chemotherapy for advanced disease

- More than 6 months since prior neoadjuvant or adjuvant systemic chemotherapy for

Endocrine therapy

- Not specified


- See Disease Characteristics

- Concurrent palliative radiotherapy allowed (except to brain metastases)


- Not specified


- No prior epidermal growth factor receptor-targeted therapy for NSCLC

- No concurrent use of any of the following CYP3A4 inducers:

- Phenytoin

- Carbamazepine

- Rifampin

- Barbiturates

- Hypericum perforatum (St. John's wort)

- More than 30 days since prior participation in another clinical trial

- No other concurrent investigational agent

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease stabilization (complete response [CR], partial response [PR], or stable disease [SD]) after 12 weeks of study treatment

Safety Issue:


Principal Investigator

Daniel C. Betticher, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospital Inselspital, Berne


Switzerland: Swissmedic

Study ID:

SAKK 19/03



Start Date:

November 2003

Completion Date:

October 2004

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • adenocarcinoma of the lung
  • large cell lung cancer
  • squamous cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms