Phase 4
N=296
Assess the Efficacy, Safety and Tolerability of Gefitinib (Iressa® 250mg) as Maintenance Therapy in Locally Advanced or Metastatic (Stage IIIB/IV) Non Small Cell Lung Cancer (NSCLC)
Non-small Cell Lung Cancer (NSCLC)
Bottom Line
View on ClinicalTrials.gov: NCT00770588 ↗Enrolled (actual)
296
Serious AEs
5.1%
Results posted
Aug 2012
Primary outcome: Primary: Progression Free Survival (PFS) — 4.8; 2.6 month
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Gefitinib (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
4.8; 2.6 | — |
| SECONDARY Overall Survival (OS) |
18.7; 16.9 | — |
| SECONDARY Objective Tumour Response (ORR) |
35; 1 | — |
| SECONDARY Disease Control Rate (DCR) |
— | — |
| SECONDARY Symptom Improvement |
34; 12 | — |
| SECONDARY Adverse Event |
118; 79 | — |
Summary
This is a double blind, multicentre, randomized, placebo-controlled study. The eligible patients will be randomized to receive gefitinib or placebo at 1:1 ratio. This study will recruit 296 male or female, histologically or cytologically diagnosed locally advanced or metastatic NSCLC patients with a World Health Organization (WHO) Performance Status (PS) 0-2. Patients must have completed 4 cycles of platinum based first line doublet chemotherapy without experiencing disease progression or unacceptable toxicity. The chemotherapy shall be given every 3 weeks, which includes cisplatin or carboplatin, combined with any one of the following: gemcitabine, paclitaxel, docetaxel, vinorelbine.
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed locally advanced or metastatic (stage=IIIB/IV) non-small cell lung cancer (NSCLC) before the front line chemotherapy. Note: sputum cytology alone is not acceptable
- Patients have completed 4 cycles of first line platinum contained doublet chemotherapy without progression or intolerable toxicity.
- Patients with PR or SD on study entry need to have one or more measurable lesions according to RECIST criteria.
- The study treatment should be started at least 3 weeks (21 days) but no more than 6 weeks (42 days) since last dose of chemotherapy, and within 4 weeks (28 days) since last tumour assessment.
Exclusion Criteria
- Prior exposure to monoclonal antibodies or small molecule inhibitors against EGFR receptors. (e.g. gefitinib, erlotinib, C225)
- Patients with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they are clinically stable and have been discontinued from steroid therapy for at least 4 weeks prior to first dose of study medication.
- Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
- Known biomarker status of one or more of the following: Tumour EGFR gene copy number, tumour EGFR gene mutation status, tumour EGFR protein expression.
Data sourced from ClinicalTrials.gov (NCT00770588). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.