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

Primary Purpose

Non-Small Cell Lung Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Gefitinib

Placebo

Pemetrexed

Cisplatin

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Non Small Cell Lung Cancer, Gefitinib, Pemetrexed, Treatment Beyond Progression

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Gefitinib

Placebo

Arm Description

Gefitinib and cisplatin plus pemetrexed combination chemotherapy

Placebo and cisplatin plus pemetrexed combination chemotherapy.

Outcomes

Primary Outcome Measures

Progression-Free Survival (Site Read, Investigator Assessment)

PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression). Progression is defined using RECIST (v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.

Median Progression-Free Survival (Site Read, Investigator Assessment)

Secondary Outcome Measures

Overall Survival (OS)

OS is the time from the date of randomisation until death due to any cause. Any subject not known to have died at the time of analysis will be censored based on the last recorded date on which the subject was known to be alive.

Median Overall Survival (OS) at Time of PFS Analysis

Objective Response Rate (ORR) (Site Read Data)

ORR rate is defined as the number (%) of subjects with at least one visit response of Complete Response (CR) or Partial Response (PR) , as defined by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions and assessed by CT or MRI. CR, Disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions. Data obtained up until progression, or last evaluable assessment in the absence of progression, was included in the assessment of ORR.

Disease Control Rate (DCR)

DCR is the percentage of patients who achieve disease control at 6 weeks following randomisation. DCR is defined as a Best Objective Response (BOR) of Complete Response, Partial Response or Stable Disease, as defined by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions and assessed by CT or MRI. CR, Disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions; SD, neither sufficient shrinkage to qualify for PR not sufficient increase to qualify for Progressive Disease (PD); PD, ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, and the sum must have shown an absolute increase of ≥5mm

Improvement in Trial Outcome Index

An improvement is defined as a change from baseline of ≥ +6 (0-84 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire.

Time to Worsening in Trial Outcome Index

A worsening is defined as a change from baseline of ≤ -6 (0-84 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire

Improvement in FACT-L Total Score

An improvement is defined as a change from baseline of ≥ +6 (0-136 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire

Time to Worsening in FACT-L Total Score

A worsening is defined as a change from baseline of ≤ -6 (0-136 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire

Improvement in Lung Cancer Subscale

An improvement is defined as a change from baseline of ≥ +2 (0-28 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire

Time to Worsening in Lung Cancer Subscale

A worsening is defined as a change from baseline of ≤ -2 (0-28 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire

Full Information

NCT ID

NCT01544179

First Posted

February 15, 2012

Last Updated

September 24, 2020

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01544179

Brief Title

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

Acronym

IMPRESS

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

March 15, 2012 (Actual)

Primary Completion Date

May 5, 2014 (Actual)

Study Completion Date

November 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Small Cell Lung Cancer

Keywords

Non Small Cell Lung Cancer, Gefitinib, Pemetrexed, Treatment Beyond Progression

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

265 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gefitinib

Arm Type

Experimental

Arm Description

Gefitinib and cisplatin plus pemetrexed combination chemotherapy

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo and cisplatin plus pemetrexed combination chemotherapy.

Intervention Type

Drug

Intervention Name(s)

Gefitinib

Intervention Description

Investigational Drug

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo as comparator

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Intervention Description

Chemotherapy (concomitant therapy)

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

Chemotherapy (concomitant therapy)

Primary Outcome Measure Information:

Title

Progression-Free Survival (Site Read, Investigator Assessment)

Description

Time Frame

Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis, assessed up to 50 weeks

Title

Median Progression-Free Survival (Site Read, Investigator Assessment)

Description

Time Frame

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

Time Frame

Following progression survival data was collected every 8 weeks until documentation of death, withdrawal of consent, loss to follow-up or the final data cut-off, whichever occurs first.

Title

Median Overall Survival (OS) at Time of PFS Analysis

Time Frame

Baseline and then every 6 weeks after randomization until objective disease progression. OS is then assessed 8 weekly following PFS progression up to PFS analysis data cut off.

Title

Objective Response Rate (ORR) (Site Read Data)

Description

Time Frame

Title

Disease Control Rate (DCR)

Description

Time Frame

Title

Improvement in Trial Outcome Index

Description

An improvement is defined as a change from baseline of ≥ +6 (0-84 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire.

Time Frame