A Study of IRESSA Treatment Beyond Progression in Addition to Chemotherapy Versus Chemotherapy Alone (IMPRESS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01544179
First received: February 15, 2012
Last updated: October 15, 2014
Last verified: October 2014
  Purpose

The purpose of this study is to assess the efficacy and safety of gefitinib in patients who have progressed on first line gefitinib, comparing continuing gefitinib in addition to cisplatin plus pemetrexed combination chemotherapy versus cisplatin plus pemetrexed combination chemotherapy alone.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: Gefitinib
Drug: Placebo
Drug: Pemetrexed
Drug: Cisplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Randomised, Double Blind, Placebo Controlled, Parallel, Multicentre Study to Assess the Efficacy and Safety of Continuing IRESSA 250 mg in Addition to Chemotherapy Versus Chemotherapy Alone in Patients Who Have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) and Have Progressed on First Line IRESSA

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Progression Free Survival (PFS) in patients with Gefitinib + Pemetrexed & Cisplatin as compared to patients with Pemetrexed & Cisplatin alone. [ Time Frame: An expected average of 48 weeks after last subject enrolled into our study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival (OS) in patients with Gefitinib + Pemetrexed & Cisplatin as compared to patients with Pemetrexed & Cisplatin alone. [ Time Frame: An expected average of 48 weeks after last subject enrolled into our study ] [ Designated as safety issue: No ]
  • Objective Response Rate (ORR) in patients with Gefitinib + Pemetrexed & Cisplatin as compared to patients with Pemetrexed & Cisplatin alone. [ Time Frame: An expected average of 48 weeks after last subject enrolled into our study ] [ Designated as safety issue: No ]
  • Disease Control Rate (DCR) in patients with Gefitinib + Pemetrexed & Cisplatin as compared to patients with Pemetrexed & Cisplatin alone. [ Time Frame: An expected average of 48 weeks after last subject enrolled into our study ] [ Designated as safety issue: No ]
  • Symptoms and HRQOL as measured by the FACT-L Trial Outcome Index (TOI) in patients with Gefitinib + Pemetrexed & Cisplatin as compared to patients with Pemetrexed & Cisplatin alone. [ Time Frame: An expected average of 48 weeks after last subject enrolled into our study ] [ Designated as safety issue: No ]
  • Safety and tolerability data: Adverse events, Serious adverse events , incidence of and reason for study drug dose interruptions and discontinuations, laboratory assessments, vital signs. [ Time Frame: From time of informed consent until 30 days after discontinuation of gefitinib/placebo treatment ] [ Designated as safety issue: Yes ]

Enrollment: 287
Study Start Date: March 2012
Estimated Study Completion Date: February 2016
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gefitinib
Gefitinib and cisplatin plus pemetrexed combination chemotherapy
Drug: Gefitinib
Investigational Drug
Drug: Pemetrexed
Chemotherapy (concomitant therapy)
Drug: Cisplatin
Chemotherapy (concomitant therapy)
Placebo Comparator: Placebo
Placebo and cisplatin plus pemetrexed combination chemotherapy.
Drug: Placebo
Matching placebo as comparator
Drug: Pemetrexed
Chemotherapy (concomitant therapy)
Drug: Cisplatin
Chemotherapy (concomitant therapy)

Detailed Description:

A Phase III Randomised, Double blind, Placebo controlled, Parallel, Multicentre Study to Assess the Efficacy and Safety of continuing IRESSA 250 mg in addition to Chemotherapy versus Chemotherapy alone in Patients who have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) and have progressed on First Line IRESSA.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients aged 18 years or older (For Japan only- male or female patients aged 20 years or older)
  • Cytological or histological confirmation of NSCLC other than predominantly squamous cell histology with an activating EGFR TK mutation as determined locally
  • Patients with documented 'acquired resistance' on first line gefitinib
  • Patients suitable to start cisplatin based pemetrexed combination chemotherapy.
  • Provision of informed consent prior to any study specific procedures.

Exclusion Criteria:

  • Prior chemotherapy or other systemic anti-cancer treatment (excluding gefitinib). Palliative bone radiotherapy must be completed at least 2 weeks before start of study treatment with no persistent radiation toxicity).
  • Past medical history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease
  • Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ or completely resected intramucosal gastric cancer
  • Any evidence of severe of uncontrolled systemic disease Treatment with an investigational drug within 4 weeks before randomization
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544179

  Show 47 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Haiyi Jiang, M.D. MSc Zhangjiang Hi-tech Park, 3F, Room 3102, 199 Liangjing Road, Pudong Shanghai, postal code:201203
Principal Investigator: Tony Mok, M.D. Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, N.T., Hong KongDepartment of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, N.T., Hong Kong
Principal Investigator: Jean-Charles Soria, MD, PHD Institute Gustave Roussy, France
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01544179     History of Changes
Other Study ID Numbers: D791LC00001
Study First Received: February 15, 2012
Last Updated: October 15, 2014
Health Authority: China: Food and Drug Administration
Hong Kong: Ethics Committee
Taiwan: Institutional Review Board
Korea: Food and Drug Administration
Japan: Ministry of Health, Labor and Welfare
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Ministry of Health
Italy: Ethics Committee
Spain: Ministry of Health and Consumption
Russia: Ministry of Health of the Russian Federation
Hungary: National Institute of Pharmacy

Keywords provided by AstraZeneca:
Non Small Cell Lung Cancer
Gefitinib
Pemetrexed
Treatment Beyond Progression

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gefitinib
Pemetrexed
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Folic Acid Antagonists

ClinicalTrials.gov processed this record on October 19, 2014