Maintenance ZD1839 (IRESSA®) Following Completion of Front Line, Platinum-Based, Double Chemotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer

• Status: Withdrawn
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

In this Phase IIIb, randomized, double-blind, maintenance study, 300 subjects with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) (Stage IIIB {T4-pleural effusion} and IV) who have SD or objective tumor response immediately following the completion of 4-6 cycles of front line, platinum-based, doublet chemotherapy will be randomized in a double-blind manner to receive either ZD1839 or placebo.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Gefitinib

Criteria

Inclusion Criteria:

• Must sign Informed Consent

• Females and males aged 18 years and over.

• Confirmed stage IIIB (T4-pleural effusion) and IV NSCLC.

• Either complete response, partial response, or stable disease following at least 4 cycles (3 in the setting of intolerable toxicity) but no more than 6 cycles of definitive front line, platinum-based, doublet chemotherapy.

• No prior EGFR therapy

• No newly diagnosed intracerebral metastases while receiving or after completing chemotherapy

• At least 3 weeks (21 days) but no more than 4 weeks (28 days) since last dose of chemotherapy

• Must be completely healed from previous major oncologic surgery

• Life expectancy of ≥ 8 weeks.

Exclusion Criteria:

• Known severe hypersensitivity to ZD1839 or any of the excipients of these products.

• Any evidence of clinically active interstitial lung disease (subjects with chronic, stable, radiographic changes who are asymptomatic need not be excluded).

• Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.

• Any unresolved chronic toxicity greater than common toxicity criteria (CTC) grade 2 from previous anticancer therapy excluding peripheral neuropathy or alopecia.

• Evidence of any significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.

• Pregnancy or breast feeding (women of child bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy.

• Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.

• Signs of neurological symptoms consistent with new onset spinal cord compression or CNS metastases.

• Treatment with any systemic anticancer therapies other than the prescribed protocol chemotherapy regimen (refer to Inclusion criterion -). Exception: Palliative radiotherapy for symptom relief of lesions present at diagnosis will be allowed; however, this radiotherapy must occur prior to completion of pre-study doublet chemotherapy.

• Males must also be willing to practice acceptable methods of birth control while taking the drug to prevent pregnancy of a partner.