Trial · 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
NCT00373425, Phase 3, Completed, OSI Pharmaceuticals; results first posted 2014-06-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT00373425. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00373425
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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
- NCT number
- NCT00373425
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,252 participants, actual
- Lead sponsor
- OSI Pharmaceuticals
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Erlotinib, Placebo
- First posted
- 2006-09-08
- Last updated
- 2015-09-17
- Other registries' IDs
- eudract:2005-001747-29
- Results first posted
- 2014-06-03
- 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.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease Free Survival (DFS) | 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. |
| Primary | Disease Free Survival (DFS) | 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 | Overall Survival (OS) | 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. |
| Secondary | Overall Survival (OS) | 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. |
| Secondary | Disease-free Survival in Participants With EGFR Mutation - Positive Tumors | 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. |
| Secondary | Disease-free Survival in Participants With EGFR Mutation - Positive Tumors | 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. |
| Secondary | Overall Survival in Participants With EGFR Mutation - Positive Tumors | 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. |
| Secondary | Overall Survival in Participants With EGFR Mutation - Positive Tumors | 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. |
| Secondary | Number of Participants With Adverse Events (AEs) | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease Free Survival (DFS) | 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). | Randomized cohort full analysis set (all randomized participants). | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | 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). | Randomized cohort full analysis set | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | 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). | Randomized cohort full analysis set | months | MEDIAN |
| SECONDARY | Disease-free Survival in Participants With EGFR Mutation - Positive Tumors | 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). | Randomized cohort full analysis set participants who are EGFR mutation positive | months | MEDIAN |
| SECONDARY | Disease-free Survival in Participants With EGFR Mutation - Positive Tumors | 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). | Randomized cohort full analysis set participants who are EGFR mutation positive | months | MEDIAN |
| PRIMARY | Disease Free Survival (DFS) | 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). | Randomized cohort full analysis set (all randomized participants). | months | MEDIAN |
| SECONDARY | Overall Survival in Participants With EGFR Mutation - Positive Tumors | 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) | Randomized cohort full analysis participants who were EGFR mutation positive | months | MEDIAN |
| SECONDARY | Overall Survival in Participants With EGFR Mutation - Positive Tumors | 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) | Randomized cohort full analysis participants who were EGFR mutation positive | months | MEDIAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) | 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. | Randomized Cohort, safety analysis set: all randomized participants who received at least one dose of study drug. One participant in the Randomized Cohort assigned to the erlotinib arm received placebo instead due to a dispensing error and is included in the placebo group for safety analyses. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease Free Survival (DFS) | Erlotinib | 50.5 | 95% Confidence Interval 44.7 to NA | months | |
| Disease Free Survival (DFS) | Placebo | 48.2 | 95% Confidence Interval 36.0 to NA | months | |
| Overall Survival (OS) | Erlotinib | NA | 95% Confidence Interval NA to NA | months | |
| Overall Survival (OS) | Placebo | NA | 95% Confidence Interval NA to NA | months | |
| Overall Survival (OS) | Erlotinib | NA | 95% Confidence Interval 77.9 to NA | months | |
| Overall Survival (OS) | Placebo | NA | 95% Confidence Interval NA to NA | months | |
| Disease-free Survival in Participants With EGFR Mutation - Positive Tumors | Erlotinib | 46.4 | 95% Confidence Interval 39.8 to NA | months | |
| Disease-free Survival in Participants With EGFR Mutation - Positive Tumors | Placebo | 28.5 | 95% Confidence Interval 16.7 to NA | months | |
| Disease-free Survival in Participants With EGFR Mutation - Positive Tumors | Erlotinib | 47.8 | 95% Confidence Interval 39.8 to 60.8 | months | |
| Disease-free Survival in Participants With EGFR Mutation - Positive Tumors | Placebo | 28.5 | 95% Confidence Interval 16.7 to 61.4 | months |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | RC: Erlotinib | 623 | |
| Overall Study | STARTED | RC: Placebo | 350 | |
| Overall Study | STARTED | BPC-NOLC: Erlotinib/Placebo | 134 | |
| Overall Study | STARTED | BPC-NOLC: Placebo Only | 11 | |
| Overall Study | STARTED | BPC-OLC: Erlotinib | 132 | |
| Overall Study | Received Treatment | RC: Erlotinib | 612 | |
| Overall Study | Received Treatment | RC: Placebo | 342 | |
| Overall Study | Received Treatment | BPC-NOLC: Erlotinib/Placebo | 134 | |
| Overall Study | Received Treatment | BPC-NOLC: Placebo Only | 7 | |
| Overall Study | Received Treatment | BPC-OLC: Erlotinib | 132 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events1,730
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Rash | Skin and subcutaneous tissue disorders | RC: Erlotinib | 356 | 611 | |
| other | Rash | Skin and subcutaneous tissue disorders | RC: Placebo | 58 | 343 | |
| other | Rash | Skin and subcutaneous tissue disorders | BPC-NOLC: Erlotinib/Placebo | 51 | 134 | |
| other | Rash | Skin and subcutaneous tissue disorders | BPC-NOLC: Placebo Only | 0 | 11 | |
| other | Rash | Skin and subcutaneous tissue disorders | BPC-OLC: Erlotinib | 72 | 132 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | RC: Erlotinib | 161 | 611 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | RC: Placebo | 51 | 343 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | BPC-NOLC: Erlotinib/Placebo | 21 | 134 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | BPC-NOLC: Placebo Only | 0 | 11 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | BPC-OLC: Erlotinib | 29 | 132 |
1 to 10 of 1,730Source ClinicalTrials.gov
See all 1,730 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RC: Erlotinib | ||
| Total, all-cause mortality | RC: Placebo | ||
| Total, all-cause mortality | BPC-NOLC: Erlotinib/Placebo | ||
| Total, all-cause mortality | BPC-NOLC: Placebo Only | ||
| Total, all-cause mortality | BPC-OLC: Erlotinib | ||
| Total, other adverse events | RC: Erlotinib | 590 | 611 |
| Total, other adverse events | RC: Placebo | 288 | 343 |
| Total, other adverse events | BPC-NOLC: Erlotinib/Placebo | 125 | 134 |
| Total, other adverse events | BPC-NOLC: Placebo Only | 4 | 11 |
| Total, other adverse events | BPC-OLC: Erlotinib | 130 | 132 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26324372 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00373425
GET https://conductscience.org/api/trials/v1/NCT00373425/results?page=2