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CompletedNCT00373425RADIANTUpdated Sep 17, 2015Results posted

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

A Phase 3 interventional study of Erlotinib and Placebo in Non-small Cell Lung Cancer, sponsored by OSI Pharmaceuticals. Completed at 295 sites in 19 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-17.

Sponsored by OSI Pharmaceuticals · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,252
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Non-small Cell Lung Cancer

Keywords

  • 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
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 1,252 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

OSI Pharmaceuticals is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,252 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugErlotinib

    150 mg tablet

    Also known as: OSI-774, Tarceva

  • DrugPlacebo

    Placebo tablet

06

What researchers measure

Primary outcomes

  1. 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.

    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).

  2. 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.

    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).

Secondary outcomes

  1. 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.

    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).

  2. 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.

    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).

  3. 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.

    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).

  4. 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.

    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).

  5. 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.

    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)

  6. 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.

    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)

  7. 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.

    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.

07

Results

Posted Jun 3, 2014
Limitations and caveats
Company makes no warranties or representations of any kind as to the currency or completeness of the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose and shall not be liable for any damages.

Participant flow

Patients with stage IB to IIIA epidermal growth factor receptor (EGFR)-positive non-small cell lung cancer (NSCLC) were enrolled globally. 1252 patients were enrolled however 2 patients did not have adequate Health Insurance Portability and Accountability Act (HIPAA) documentation and were removed from the database.

Participant flow — Overall Study
MilestoneRC: ErlotinibRC: PlaceboBPC-NOLC: Erlotinib/PlaceboBPC-NOLC: Placebo OnlyBPC-OLC: Erlotinib
Started62335013411132
Received treatment6123421347132
Completed2531970060
Not completed3701531341172
Withdrew: Relapse of nsclc11610419226
Withdrew: Adverse event1912259034
Withdrew: Patient request35184367
Withdrew: Medical/ethical/noncompliance reason2191025
Withdrew: Death70310

Outcome measures

PrimaryDisease 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.

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).
Reported as:
Median · months
Disease Free Survival (DFS)
monthsErlotinibPlacebo
Disease Free Survival (DFS)50.5 (44.7 to NA)48.2 (36.0 to NA)
Statistical analysis
  • Erlotinib vs Placebo · Log Rank · p = 0.3235 (If the primary analysis of DFS was not statistically significant, the hierarchical testing procedure would stop and all key secondary efficacy analyses would be nonsignificant; any further analysis of these outcomes would be considered exploratory.) · Hazard ratio (hr): 0.90 · 95% CI 0.741 to 1.104Hazard ratio: erlotinib to placebo
SecondaryOverall 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.

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).
Reported as:
Median · months
Overall Survival (OS)
monthsErlotinibPlacebo
Overall Survival (OS)NA (NA to NA)NA (NA to NA)
SecondaryOverall 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.

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).
Reported as:
Median · months
Overall Survival (OS)
monthsErlotinibPlacebo
Overall Survival (OS)NA (77.9 to NA)NA (NA to NA)
SecondaryDisease-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.

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).
Reported as:
Median · months
Disease-free Survival in Participants With EGFR Mutation - Positive Tumors
monthsErlotinibPlacebo
Disease-free Survival in Participants With EGFR Mutation - Positive Tumors46.4 (39.8 to NA)28.5 (16.7 to NA)
SecondaryDisease-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.

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).
Reported as:
Median · months
Disease-free Survival in Participants With EGFR Mutation - Positive Tumors
monthsErlotinibPlacebo
Disease-free Survival in Participants With EGFR Mutation - Positive Tumors47.8 (39.8 to 60.8)28.5 (16.7 to 61.4)
PrimaryDisease 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.

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).
Reported as:
Median · months
Disease Free Survival (DFS)
monthsErlotinibPlacebo
Disease Free Survival (DFS)55.0 (47.0 to 64.5)56.2 (39.7 to 65.6)
Statistical analysis
  • Erlotinib vs Placebo · Log Rank · p = 0.5620 · Hazard ratio (hr): 0.94 · 95% CI 0.780 to 1.144
SecondaryOverall 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.

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)
Reported as:
Median · months
Overall Survival in Participants With EGFR Mutation - Positive Tumors
monthsErlotinibPlacebo
Overall Survival in Participants With EGFR Mutation - Positive TumorsNA (NA to NA)NA (55.4 to NA)
SecondaryOverall 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.

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)
Reported as:
Median · months
Overall Survival in Participants With EGFR Mutation - Positive Tumors
monthsErlotinibPlacebo
Overall Survival in Participants With EGFR Mutation - Positive TumorsNA (NA to NA)NA (NA to NA)
SecondaryNumber 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.

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.
Reported as:
Number · participants
Number of Participants With Adverse Events (AEs)
participantsErlotinibPlacebo
Any adverse event (AE)599307
Grade 3 or higher adverse event27996
Serious adverse event (SAE)11879
AE leading to discontinuation of study drug20529
AE leading to death145
AE leading to dose reduction1509
AE leading to dose interruption11423
AE leading to dose interruption and reduction1565
Drug-related AE572181
Drug-related serious AE155
Drug-related AE leading to discontinuation1638

Adverse events

Collected over From the first dose of study drug until 30 days after the last dose. Maximum time on treatment for the Randomized Cohort was 24 months; maximum time on treatment for the BPC was 13 months on blinded study drug and 26 months on open-label erlotinib.. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
RC: Erlotinib—118/611 (19.3%)590/611 (96.6%)
RC: Placebo—79/343 (23%)288/343 (84%)
BPC-NOLC: Erlotinib/Placebo—21/134 (15.7%)125/134 (93.3%)
BPC-NOLC: Placebo Only—1/11 (9.1%)4/11 (36.4%)
BPC-OLC: Erlotinib—41/132 (31.1%)130/132 (98.5%)
Most frequent serious events
Showing 10 of 249
Most frequent serious events
EventRC: ErlotinibRC: PlaceboBPC-NOLC: Erlotinib/PlaceboBPC-NOLC: Placebo OnlyBPC-OLC: Erlotinib
ApnoeaRespiratory, thoracic and mediastinal disorders0/6110/3430/1341/110/132
PneumoniaInfections and infestations8/6112/3432/1340/113/132
Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)3/6111/3430/1340/113/132
Lung neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps)5/6113/3430/1340/112/132
Small cell lung cancer stage unspecifiedNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/6110/3430/1340/112/132
Mental status changesPsychiatric disorders0/6111/3430/1340/112/132
NauseaGastrointestinal disorders0/6111/3432/1340/111/132
VomitingGastrointestinal disorders0/6111/3432/1340/111/132
DyspnoeaRespiratory, thoracic and mediastinal disorders6/6115/3430/1340/111/132
Pulmonary embolismRespiratory, thoracic and mediastinal disorders3/6115/3430/1340/110/132
Most frequent other events
Showing 10 of 97
Most frequent other events
EventRC: ErlotinibRC: PlaceboBPC-NOLC: Erlotinib/PlaceboBPC-NOLC: Placebo OnlyBPC-OLC: Erlotinib
DiarrhoeaGastrointestinal disorders318/61154/34354/1340/1186/132
RashSkin and subcutaneous tissue disorders356/61158/34351/1340/1172/132
Dermatitis acneiformSkin and subcutaneous tissue disorders111/61119/34337/1340/1145/132
Dry skinSkin and subcutaneous tissue disorders127/61150/34315/1340/1141/132
PruritusSkin and subcutaneous tissue disorders161/61151/34321/1340/1129/132
FatigueGeneral disorders118/61149/34323/1340/1134/132
CoughRespiratory, thoracic and mediastinal disorders121/61169/34317/1340/1129/132
NauseaGastrointestinal disorders84/61144/34317/1341/1128/132
DyspnoeaRespiratory, thoracic and mediastinal disorders85/61161/34315/1340/1118/132
AlopeciaSkin and subcutaneous tissue disorders67/61111/34312/1340/1122/132

Baseline characteristics

Age, Continuous
Age, Continuous(years)RC: ErlotinibRC: PlaceboBPC-NOLC: Erlotinib/PlaceboBPC-NOLC: Placebo OnlyBPC-OLC: ErlotinibTotal
Randomized Cohort62.0 ± 9.2861.8 ± 9.34NA ± NANA ± NANA ± NA61.9 ± 9.30
Breached Protocol Cohort, No Open labelNA ± NANA ± NA64.4 ± 9.3362.7 ± 6.23NA ± NA64.3 ± 9.13
Breached Protocol Cohort, Open labelNA ± NANA ± NANA ± NANA ± NA61.8 ± 9.3561.8 ± 9.35
Sex: Female, Male
Sex: Female, Male(Participants)RC: ErlotinibRC: PlaceboBPC-NOLC: Erlotinib/PlaceboBPC-NOLC: Placebo OnlyBPC-OLC: ErlotinibTotal
Female25714147257504
Male36620987975746
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)RC: ErlotinibRC: PlaceboBPC-NOLC: Erlotinib/PlaceboBPC-NOLC: Placebo OnlyBPC-OLC: ErlotinibTotal
White500279114101111014
Black141140433
Asian1076015117200
American Indian/Alaska Native101002
Other100001
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)RC: ErlotinibRC: PlaceboBPC-NOLC: Erlotinib/PlaceboBPC-NOLC: Placebo OnlyBPC-OLC: ErlotinibTotal
Not Hispanic or Latino583322123111241163
Hispanic or Latino4028110887
Eastern Cooperative Oncology Group (ECOG) Performance Status
Eastern Cooperative Oncology Group (ECOG) Performance Status(participants)RC: ErlotinibRC: PlaceboBPC-NOLC: Erlotinib/PlaceboBPC-NOLC: Placebo OnlyBPC-OLC: ErlotinibTotal
Grade 038521175577753
Grade 123013455654479
Grade 26530115
Not measured201003
Cigarette Smoking History
Cigarette Smoking History(participants)RC: ErlotinibRC: PlaceboBPC-NOLC: Erlotinib/PlaceboBPC-NOLC: Placebo OnlyBPC-OLC: ErlotinibTotal
Never smoked or ≤ 100 cigarettes in lifetime1297019119238
Former smoker4232401039104879
Current smoker71401219133
Histology
Histology(participants)RC: ErlotinibRC: PlaceboBPC-NOLC: Erlotinib/PlaceboBPC-NOLC: Placebo OnlyBPC-OLC: ErlotinibTotal
Adenocarcinoma36721173376730
Squamous cell carcinoma19611148849412
Undifferentiated large cell22860440
Mixed NSCLC291850153
Other9220215
Extent of Disease at Diagnosis
Extent of Disease at Diagnosis(participants)RC: ErlotinibRC: PlaceboBPC-NOLC: Erlotinib/PlaceboBPC-NOLC: Placebo OnlyBPC-OLC: ErlotinibTotal
Stage IA121004
Stage IB32916764480644
Stage IIA4224101986
Stage IIB1559936423317
Stage IIIA935821117190
Stage IIIB202037
Stage IV100102

3 further baseline measures are reported on the registry.

08

Study locations

295 sites
  • University of Alabama at Birmingham
    Birmingham, Alabama 35294, United States
  • Arizona Cancer Center
    Tucson, Arizona 85724, United States
  • University of Arkansas for Medical Science
    Little Rock, Arkansas 72205, United States
  • Tower Cancer Research Foundation
    Beverly Hills, California 90211, United States
  • City of Hope Nat'l Medical Center
    Duarte, California 91010, United States
  • Loma Linda University Medical Center
    Loma Linda, California 92354, United States
  • USC/ Norris Comprehensive Cancer Center
    Los Angeles, California 90033, United States
  • Cedars-Sinai Medical Center
    Los Angeles, California 90048, United States
  • Hoag Memorial Hospital Presbyterian
    Newport Beach, California 92658, United States
  • Comprehensive Cancer Center at Desert Regional Medical Center
    Palm Springs, California 92262, United States
  • Bay Area Cancer Research Group, LLC
    Pleasant Hill, California 94523, United States
  • University of California, San Francisco Comprehensive Cancer Center
    San Francisco, California 94143-1770, United States
  • City of Hope Medical Group (COHMG)
    South Pasadena, California 91030, United States
  • Rocky Mountain Cancer Center- Aurora
    Aurora, Colorado 80012, United States
  • University of Colorado Hospital
    Aurora, Colorado 80045, United States
  • Rocky Mountain Cancer Centers-Boulder
    Boulder, Colorado 80303, United States
  • Penrose St. Francis Health Services
    Colorado Springs, Colorado 80907, United States
  • Rocky Mountain Cancer Center
    Colorado Springs, Colorado 80907, United States
  • Rocky Mountain Cancer Center
    Colorado Springs, Colorado 80909, United States
  • Rocky Mountain Cancer Center-Midtown
    Denver, Colorado 80218, United States
  • Rocky Mountain Cancer Centers- Rose
    Denver, Colorado 80220, United States
  • Rocky Mountain Cancer Centers
    Lakewood, Colorado 80228, United States
  • Rocky Mountain Cancer Centers-Littleton
    Littleton, Colorado 80120-4413, United States
  • Rocky Mountain Cancer Center-Sky Ridge
    Lone Tree, Colorado 80124, United States
  • Rocky Mountain Cancer Centers-Longmont
    Longmont, Colorado 80501, United States
  • Rocky Mountain Cancer Center-Parker
    Parker, Colorado 80138, United States
  • Rocky Mountain Cancer Centers
    Thornton, Colorado 80260, United States
  • Yale University
    New Haven, Connecticut 06520, United States
  • Smilow Cancer Hospital Care Center
    Sharon, Connecticut 06069, United States
  • Hematology Oncology, P.C.
    Stamford, Connecticut 06902, United States
  • Smilow Cancer Hospital Care Center
    Torrington, Connecticut 06790, United States
  • Florida Cancer Institute-New Hope
    Hudson, Florida 34667, United States
  • Cancer Specialists of North Florida
    Jacksonville, Florida 32204, United States
  • Cancer Specialists of North Florida
    Jacksonville, Florida 32216, United States
  • Watson Clinic LLP
    Lakeland, Florida 33805, United States
  • Advanced Medical Specialties
    Miami, Florida 33176, United States
  • Florida Cancer Institute- New Hope
    New Port Richey, Florida 34655, United States
  • Florida Cancer Specialists
    Orlando, Florida 32806, United States
  • Hematology Oncology Associates of the Treasure Coast
    Port St. Lucie, Florida 34952, United States
  • Peachtree Hematology-Oncology Consultants, P.C.
    Atlanta, Georgia 30318, United States
  • Central Georgia Cancer Care, PC
    Macon, Georgia 31201, United States
  • Northwest Georgia Oncology Centers, PC
    Marietta, Georgia 30060, United States
  • Mountain States Tumor Institute
    Boise, Idaho 83712, United States
  • Mountain States Tumor Institute
    Meridian, Idaho 83642, United States
  • Kootenai Cancer Center
    Post Falls, Idaho 83854, United States
  • Mountain States Tumor Institute
    Twin Falls, Idaho 83301, United States
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
  • University of Chicago, Section of Hematology/Oncology
    Chicago, Illinois 60637, United States
  • Joliet Oncology Hematology Assoc., LTD
    Joliet, Illinois 60435, United States
  • Loyola University Medical Center
    Maywood, Illinois 60153, United States
  • Indiana University Health
    Carmel, Indiana 46032, United States
  • Indiana University Health
    Fishers, Indiana 46037, United States
  • Indiana University Health
    Greenfield, Indiana 46140, United States
  • Indiana University Health
    Indianapolis, Indiana 46219, United States
  • Indiana University Health
    Indianapolis, Indiana 46227, United States
  • University of Kansas Medical Center
    Westwood, Kansas 66205, United States
  • Norton Healthcare, Inc.
    Louisville, Kentucky 40202, United States
  • Leonard J. Chabert Medical Center
    Houma, Louisiana 70363, United States
  • Cancer Care of Maine
    Brewer, Maine 04412, United States
  • Greater Baltimore Medical Center
    Baltimore, Maryland 21204, United States
  • St. Joseph Medical Center's Cancer Institute
    Towson, Maryland 21204, United States
  • Caritas St. Elizabeth's Medical Center
    Boston, Massachusetts 02135, United States
  • St. Joseph Mercy Hospital
    Ann Arbor, Michigan 48106, United States
  • Minnesota Oncology Hematology, P.A.
    Burnsville, Minnesota 55337, United States
  • Minnesota Oncology Hematology, P.A.
    Edina, Minnesota 55435-2150, United States
  • Minnesota Oncology Hematology, P.A.
    Maplewood, Minnesota 55109, United States
  • Minnesota Oncology Hematology, P.A.
    Minneapolis, Minnesota 55404, United States
  • Minnesota Oncology Hematology
    St. Paul, Minnesota 55102-2389, United States
  • Minnesota Oncology Hematology, P.A.
    Woodbury, Minnesota 55125, United States
  • Missouri Cancer Associates
    Columbia, Missouri 65201, United States
  • Heartland Regional Medical Center d/b/a Heartland Clinic
    St. Joseph, Missouri 64507, United States
  • St. Francis Cancer Treatment Center
    Grand Island, Nebraska 68803, United States
  • Nebraska Methodist Hospital
    Omaha, Nebraska 68114, United States
  • Comprehensive Cancer Centers of Nevada
    Henderson, Nevada 89052, United States
  • Comprehensive Cancer Centers of Nevada
    Las Vegas, Nevada 89128, United States
  • Comprehensive Cancer Centers of Nevada
    Las Vegas, Nevada 89148, United States
  • Comprehensive Cancer Centers of Nevada
    Las Vegas, Nevada 89169, United States
  • NH Oncology-Hematology PA (Co)
    Concord, New Hampshire 03301, United States
  • NH Oncology-Hematology PA
    Hooksett, New Hampshire 03106, United States
  • Dartmouth-Hitchcock Medical Center
    Lebanon, New Hampshire 03756, United States
  • Hackensack University Medical Center
    Hackensack, New Jersey 07601, United States
  • University of New Mexico Health Science Center
    Albuquerque, New Mexico 87131, United States
  • Christus St. Vincent Regional Cancer Center
    Santa Fe, New Mexico 87505, United States
  • Interlakes Oncology Hematology, PC
    Brockport, New York 14420, United States
  • Montefiore Medical Center
    Bronx, New York 10467, United States
  • Interlakes Oncology Hematology, PC
    Canadaigua, New York 14424, United States
  • Interlakes Oncology Hematology, PC
    Geneva, New York 14456, United States
  • Advanced Oncology Associates
    New Rochelle, New York 10801, United States
  • The New York Presbyterian-Weill Medical College of Cornell University
    New York, New York 10065, United States
  • Interlakes Oncology Hematology, PC
    Rochester, New York 14623, United States
  • Interlakes Oncology Hematology, PC
    Rochester, New York 14626, United States
  • Stony Brook University Medical Center
    Stony Brook, New York 11794, United States
  • Raleigh Hematology Oncology Associates d/b/a Cancer Center of North Carolina
    Cary, North Carolina 27511, United States
  • Carolina Oncology Specialists PA
    Hickory, North Carolina 28602, United States
  • Raleigh Hematology Oncology Associates
    Raleigh, North Carolina 27607, United States
  • Raleigh Hematology Oncology Associates
    Raleigh, North Carolina 27609, United States
  • Aultman Hospital/ North Canton Medical Foundation
    Canton, Ohio 44710, United States
  • University Hopsitals of Cleveland
    Cleveland, Ohio 44106, United States
  • Hematology Oncology Consultants Inc.
    Columbus, Ohio 43228, United States
  • Earle A Chiles Research Institute
    Portland, Oregon 97213, United States

Showing the first 100 of 295 sites across 19 countries.

09

References and documents

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. PubMed 26324372 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00373425
Lead sponsor
OSI Pharmaceuticals
Responsible party
Sponsor
First posted
Sep 8, 2006
Start date
Sep 2006
Primary completion
Apr 2013
Completion
Jun 2014
Results posted
Jun 3, 2014
Last update
Sep 17, 2015

Study contacts

Medical Monitor
study director · Astellas Pharma Global Development

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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