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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 (RADIANT)

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ClinicalTrials.gov Identifier: NCT00373425
Recruitment Status : Completed
First Posted : September 8, 2006
Results First Posted : June 3, 2014
Last Update Posted : September 17, 2015
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( OSI Pharmaceuticals )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Erlotinib Drug: Placebo Phase 3

Detailed Description:
After the initiation of the study, the sponsor became aware of an error in the drug dispensing module of the interactive voice response such that most patients who were randomized prior to 07 November 2007 were dispensed the incorrect study drug at least once. Since the integrity of the data from these patients was seriously compromised, these patients were considered unevaluable for the protocol-specified analyses. These participants are referred to as the breached protocol cohort (BPC) and those still on study treatment at the time of the breach were offered the option of receiving open-label erlotinib for up to 2 years (including posttreatment and long-term follow-up assessments), not receiving open-label erlotinib but remaining in the study for posttreatment and long-term follow-up assessment, or withdrawing consent from treatment and further assessments. Participants who had discontinued study treatment prior to the breach were not offered open-label erlotinib and remained in long-term follow-up. Data from the BPC participants were analyzed separately and were not included in the assessments of primary or secondary endpoints in the randomized cohort and were not considered part of the primary analyses.The sample size for the randomized cohort was not changed due to the BPC and the data from RC and BPC were analyzed separately.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : September 2006
Actual Primary Completion Date : April 2013
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Erlotinib
150 mg tablet
Other Names:
  • OSI-774
  • Tarceva
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.
 Drug: Placebo
Placebo tablet


Outcome Measures
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Primary Outcome Measures :
  1. Disease Free Survival (DFS) [ Time Frame: 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). ]
    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.

  2. Disease Free Survival (DFS) [ Time Frame: 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). ]
    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.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 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). ]
    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.

  2. Overall Survival (OS) [ Time Frame: 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). ]
    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.

  3. Disease-free Survival in Participants With EGFR Mutation - Positive Tumors [ Time Frame: 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). ]
    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.

  4. Disease-free Survival in Participants With EGFR Mutation - Positive Tumors [ Time Frame: 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). ]
    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.

  5. Overall Survival in Participants With EGFR Mutation - Positive Tumors [ Time Frame: 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) ]

    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.


  6. Overall Survival in Participants With EGFR Mutation - Positive Tumors [ Time Frame: 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) ]

    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.


  7. Number of Participants With Adverse Events (AEs) [ Time Frame: 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. ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00373425


Locations
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Sponsors and Collaborators
OSI Pharmaceuticals
Investigators
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Study Director: Medical Monitor Astellas Pharma Global Development
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: OSI Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00373425    
Other Study ID Numbers: OSI-774-302
2005-001747-29 ( EudraCT Number )
First Posted: September 8, 2006    Key Record Dates
Results First Posted: June 3, 2014
Last Update Posted: September 17, 2015
Last Verified: September 2015
Keywords provided by Astellas Pharma Inc ( OSI Pharmaceuticals ):
Adjuvant Non-small Cell Lung Cancer
Tarceva
Early-stage Lung Cancer
Adjuvant
RADIANT
 NSCLC
EGFR-positive tumor
Stage IB Non-small Cell Lung Cancer
Stage II Non-small Cell Lung Cancer
Stage IIIA Non-small Cell Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Tyrosine Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents