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Completed

NCT Number: NCT00373425

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

COIR, Mendoza, Mendoza Province, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Erlotinib

Drug

150 mg tablet

Other names: OSI-774, Tarceva

Placebo

Drug

Placebo tablet

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

OSI Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: RADIANT

Important dates

Study start
2006
Primary completion
2013
Study completion
2014
First posted
Sep 8, 2006
Registry last updated
Sep 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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