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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00373425
Ethics application status
Date submitted
7/09/2006
Date registered
8/09/2006
Date last updated
17/09/2015

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)
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)
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)
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)
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
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
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
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
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)
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
Sex
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
1/09/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2014
Sample size
Target
Accrual to date
Final
1252
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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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/study/NCT00373425
Trial related presentations / publications
Kelly K, Altorki NK, Eberhardt WE, O'Brien ME, Spigel DR, Crino L, Tsai CM, Kim JH, Cho EK, Hoffman PC, Orlov SV, Serwatowski P, Wang J, Foley MA, Horan JD, Shepherd FA. Adjuvant Erlotinib Versus Placebo in Patients With Stage IB-IIIA Non-Small-Cell Lung Cancer (RADIANT): A Randomized, Double-Blind, Phase III Trial. J Clin Oncol. 2015 Dec 1;33(34):4007-14. doi: 10.1200/JCO.2015.61.8918. Epub 2015 Aug 31.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00373425