Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00373425




Trial ID
NCT00373425
Ethics application status
Date submitted
7/09/2006
Date registered
7/09/2006
Date last updated
1/09/2015

Titles & IDs
Public title
A Study of Erlotinib (Tarceva) After Surgery With or Without Adjuvant Chemotherapy in Non-Small Cell Lung Carcinoma (NSCLC) Patients Who Have Epidermal Growth Factor Receptor (EGFR) Positive Tumors
Scientific title
A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Single-agent Tarceva® (Erlotinib) Following Complete Tumor Resection With or Without Adjuvant Chemotherapy in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma Who Have EGFR-positive Tumors
Secondary ID [1] 0 0
2005-001747-29
Secondary ID [2] 0 0
OSI-774-302
Universal Trial Number (UTN)
Trial acronym
RADIANT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Erlotinib
Treatment: Drugs - Placebo

Experimental: Erlotinib - Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.

Placebo Comparator: Placebo - Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.


Treatment: Drugs: Erlotinib
150 mg tablet

Treatment: Drugs: Placebo
Placebo tablet

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease Free Survival (DFS) - DFS is the time from the date of randomization until the first day non-small cell lung cancer (NSCLC) relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date.
Timepoint [1] 0 0
Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).
Primary outcome [2] 0 0
Disease Free Survival (DFS) - DFS is the time from the date of randomization until the first day that non-small cell lung cancer (NSCLC) relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date.
Timepoint [2] 0 0
Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cutoff date of 11 June 2014 (maximum time on follow-up was 78 months).
Secondary outcome [1] 0 0
Overall Survival (OS) - Overall survival was defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.
Timepoint [1] 0 0
Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).
Secondary outcome [2] 0 0
Overall Survival (OS) - Overall survival was defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.
Timepoint [2] 0 0
Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months).
Secondary outcome [3] 0 0
Disease-free Survival in Participants With EGFR Mutation - Positive Tumors - Disease-free survival (DFS) is the time from the date of randomization until the first day NSCLC relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date. Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected.
Timepoint [3] 0 0
Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).
Secondary outcome [4] 0 0
Disease-free Survival in Participants With EGFR Mutation - Positive Tumors - Disease-free survival (DFS) is the time from the date of randomization until the first day NSCLC relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date. Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected.
Timepoint [4] 0 0
Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months).
Secondary outcome [5] 0 0
Overall Survival in Participants With EGFR Mutation - Positive Tumors - Overall survival is defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.
Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected.
Timepoint [5] 0 0
Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months)
Secondary outcome [6] 0 0
Overall Survival in Participants With EGFR Mutation - Positive Tumors - Overall survival is defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.
Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected.
Timepoint [6] 0 0
Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months)
Secondary outcome [7] 0 0
Number of Participants With Adverse Events (AEs) - An AE was defined as any untoward medical occurrence in a study participant and did not necessarily have a causal relationship with study treatment.
An AE was considered serious if it resulted in death, a life-threatening situation, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a participant, other important medical events, or is on the Astellas Always Serious List.
A drug-related AE was any AE with at least a possible relationship to study treatment as assessed by the investigator. Severity was graded by the investigator according to the National Cancer Institute Common Terminology Criteria for Adverse Events, v3.0, where Grade 1=Mild AE; Grade=2 Moderate AE; Grade 3=Severe AE; Grade 4=Life-threatening or disabling; Grade 5=Death related to AE. AEs leading to death include deaths that occurred more than 30 days after the last dose of study drug.
Timepoint [7] 0 0
From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 11.9 months for erlotinib and 21.9 months for placebo. Data are based off the 11 June 2014 data cut-off date.

Eligibility
Key inclusion criteria
- Primary tissue from patient's surgery must be epidermal growth factor receptor
(EGFR)-positive by certain tests

- Patients may have up to 4 cycles of chemotherapy after surgery

- Complete removal of the tumor by surgery

- Able to start drug under the following timelines:

- 6 months from the day of surgery for patients who get chemotherapy

- 3 months from the day of surgery for those who do not get chemotherapy

- Confirmed diagnosis of Stage IB-IIIA NSCLC

- Patients must be accessible for follow-up visits
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of prior radiotherapy for NSCLC either before or after surgery

- History of heart disease or uncontrolled heart arrhythmias within the previous year

- History of poorly controlled gastrointestinal (GI) disorders that could affect the
absorption of study drug

- History of other cancer except certain skin or cervical cancers, patients who have had
other cancer are eligible if they have remained disease free for at least 5 years

- Patients who have received chemotherapy for NSCLC before surgery

- Tumors with mixed histology of NSCLC and Small Cell Lung Cancer (SCLC). Patients with
carcinoid tumors are not eligible.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [4] 0 0
Monash Medical Centre - East Bentleigh
Recruitment hospital [5] 0 0
St Vincent`s Hospital Melbourne - Fitzroy
Recruitment hospital [6] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [7] 0 0
Respiratory Clinical Trials Pty., Ltd - Adelaide
Recruitment hospital [8] 0 0
Ashford Cancer Centre - Ashford
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
3165 - East Bentleigh
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
5067 - Adelaide
Recruitment postcode(s) [8] 0 0
SA 5037 - Ashford
Recruitment outside Australia
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Dolj
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Leeds
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London
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United Kingdom
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Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
OSI Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a study to evaluate the effectiveness of erlotinib compared with a placebo sugar pill
following complete surgical removal of the tumor with or without chemotherapy after surgery
in Stage IB-IIIA NSCLC patients.
Trial website
https://clinicaltrials.gov/show/NCT00373425
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Astellas Pharma Global Development
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries