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)

NCT00770588 | Completed Phase 4 Results

• 1 other identifier: D7913L00071
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Non-small Cell Lung Cancer (NSCLC)

Keywords

non-small cell lung cancer (NSCLC); Gefitinib

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  PFS will be calculated from the tumour measurements collected at each tumour assessment per the RECIST criteria and/or the date of patient death. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.The primary analysis of PFS will be performed when at least 265 events have occurred, which is expected to occur approximately.

Secondary Outcomes (5)

• Overall Survival (OS)

  The OS will be assessed from the time of randomization to death from any cause.For patients not known to have died or who have withdrawn from the study for whatever reason,OS will be censored at the last date at which patients were known to be alive.

• Objective Tumour Response (ORR)

  TTumour assessment using RECIST will be performed at baseline then every 42 days (6 weeks) ± 7 days (1 week) from randomisation until objective progression or death from any cause.

• Disease Control Rate (DCR)

  Tumour assessment using RECIST will be performed at baseline then every 42 days (6 weeks) ± 7 days (1 week) from randomisation until objective progression or death from any cause.

• Symptom Improvement

  at randomization, every 6 weeks until disease progression, and at discontinuation.

• Adverse Event

  AEs and SAEs must be collected from the time that the main study informed consent is obtained to 28 days after discontinuation of study drug. Any ongoing AE or SAE at discontinuation of study treatment and during 28 day follow-up period must be monitored

Study Arms (2)

gefitinib

EXPERIMENTAL

Gefitinib (Iressa® 250 mg) 1 tablet daily

Drug: Gefitinib

placebo

PLACEBO COMPARATOR

placebo 1 tablet daily

Drug: Placebo

Interventions

Gefitinib DRUG

Dose form: 250 mg/tablet; Route: oral; Frequency: 1 tablet per day; Duration: until to objective PD

Also known as: Iressa

gefitinib

Placebo DRUG

To match Gefitinib

placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (14)

Research Site

Beijing, Beijing Municipality, China

Location

Research Site

Fuzhou, Fujian, China

Location

Research Site

Guangzhou, Guangdong, China

Location

Research Site

Nanning, Guangxi, China

Location

Research Site

Zhengzhou, Henan, China

Location

Research Site

Wuhan, Hubei, China

Location

Research Site

Nanjing, Jiangsu, China

Location

Research Site

Changchun, Jilin, China

Location

Research Site

Shengyang, Liaoning, China

Location

Research Site

Shanghai, Shanghai Municipality, China

Location

Research Site

Xi’an, Shanxi, China

Location

Research Site

Chengdu, Sichuan, China

Location

Research Site

Tianjin, Tianjin Municipality, China

Location

Research Site

Hangzhou, Zhejiang, China

Location

Related Publications (2)

• Zhao H, Fan Y, Ma S, Song X, Han B, Cheng Y, Huang C, Yang S, Liu X, Liu Y, Lu S, Wang J, Zhang S, Zhou C, Wang M, Zhang L; INFORM investigators. Final overall survival results from a phase III, randomized, placebo-controlled, parallel-group study of gefitinib versus placebo as maintenance therapy in patients with locally advanced or metastatic non-small-cell lung cancer (INFORM; C-TONG 0804). J Thorac Oncol. 2015 Apr;10(4):655-64. doi: 10.1097/JTO.0000000000000445.

  PMID: 25546556 DERIVED

• Zhang L, Ma S, Song X, Han B, Cheng Y, Huang C, Yang S, Liu X, Liu Y, Lu S, Wang J, Zhang S, Zhou C, Zhang X, Hayashi N, Wang M; INFORM investigators. Gefitinib versus placebo as maintenance therapy in patients with locally advanced or metastatic non-small-cell lung cancer (INFORM; C-TONG 0804): a multicentre, double-blind randomised phase 3 trial. Lancet Oncol. 2012 May;13(5):466-75. doi: 10.1016/S1470-2045(12)70117-1. Epub 2012 Apr 17.

  PMID: 22512843 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

52564555

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2008
• First Posted: October 10, 2008
• Study Start: September 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: February 1, 2011
• Last Updated: February 8, 2016
• Results First Posted: August 20, 2012

Record last verified: 2012-08

Locations

CN (14)