Trial · NCT00457392
A Study In Patients With Non-Small Cell Lung Cancer To Test If Erlotinib Plus SU011248 Is Better Than Erlotinib Alone
NCT00457392, Phase 3, Completed, Pfizer; results first posted 2011-08-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study In Patients With Non-Small Cell Lung Cancer To Test If Erlotinib Plus SU011248 Is Better Than Erlotinib Alone. Trials, record NCT00457392. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00457392
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study In Patients With Non-Small Cell Lung Cancer To Test If Erlotinib Plus SU011248 Is Better Than Erlotinib Alone
- NCT number
- NCT00457392
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 960 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Carcinoma, Non-Small Cell Lung
- Interventions
- erlotinib, sunitinib, erlotinib, placebo
- First posted
- 2007-04-06
- Last updated
- 2013-10-29
- Results first posted
- 2011-08-02
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Baseline to death or 28 days after last dose for the last participant | Overall survival is the duration from assignment to study medication to death. For participants who are alive, overall survival is censored at the last contact. |
| Secondary | Progression-Free Survival (PFS) | Baseline to disease progression or death due to any cause or 28 days after last dose | Time in weeks from assignment to study medication to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was "Death"). |
| Secondary | Percentage of Participants With Objective Response (OR) | Baseline to disease progression or discontinuation from study or 28 days after last dose | Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent. |
| Secondary | Duration of Response (DR) | Baseline to disease progression or death or discontinuation from study or 28 days after last dose | Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. |
| Secondary | One-year Survival Probability | Baseline until death or until 28 days after last dose for the last participant | The 1 year survival probability was defined as the probability of survival at one year after the date of the start of the study treatment based on the Kaplan Meier estimate. |
| Secondary | EuroQol 5-Dimension Questionnaire (EQ-5D)- Health State Profile Utility Score | Baseline and End of Treatment (EOT) or Withdrawal | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | Baseline to death or 28 days after last dose for the last participant | The Full Analysis (FA) set included all participants who were randomized, with study drug assignment designated according to actual randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized. | Months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) | Baseline to disease progression or death due to any cause or 28 days after last dose | The FA set included all participants who were randomized, with study drug assignment designated according to actual randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized. | Weeks | MEDIAN |
| SECONDARY | Percentage of Participants With Objective Response (OR) | Baseline to disease progression or discontinuation from study or 28 days after last dose | The FA set included all participants who were randomized, with study drug assignment designated according to actual randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DR) | Baseline to disease progression or death or discontinuation from study or 28 days after last dose | DR was calculated for the subgroup of participants from the FA set, with a confirmed objective tumor response. | Weeks | MEDIAN |
| SECONDARY | One-year Survival Probability | Baseline until death or until 28 days after last dose for the last participant | The FA set included all participants who were randomized, with study drug assignment designated according to actual randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized. | Percent chance of survival | NUMBER |
| SECONDARY | EuroQol 5-Dimension Questionnaire (EQ-5D)- Health State Profile Utility Score | Baseline and End of Treatment (EOT) or Withdrawal | Patients Reported Outcome (PRO) Analysis Set included participants from the FA population who had at least one EQ-5D assessment while on treatment. The 'n' signifies those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively. | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Sunitinib + Erlotinib | 9.0 | 95% Confidence Interval 8.4 to 10.2 | Months | |
| Overall Survival (OS) | Erlotinib | 8.5 | 95% Confidence Interval 7.4 to 9.8 | Months | |
| Progression-Free Survival (PFS) | Sunitinib + Erlotinib | 15.5 | 95% Confidence Interval 13.1 to 16.1 | Weeks | |
| Progression-Free Survival (PFS) | Erlotinib | 8.7 | 95% Confidence Interval 8.3 to 12.8 | Weeks | |
| Percentage of Participants With Objective Response (OR) | Sunitinib + Erlotinib | 10.60 | 95% Confidence Interval 8.01 to 13.73 | Percentage of participants | |
| Percentage of Participants With Objective Response (OR) | Erlotinib | 6.90 | 95% Confidence Interval 4.78 to 9.52 | Percentage of participants | |
| Duration of Response (DR) | Sunitinib + Erlotinib | 39.6 | 95% Confidence Interval 31.3 to 48.9 | Weeks | |
| Duration of Response (DR) | Erlotinib | 32.3 | 95% Confidence Interval 24.2 to 48.0 | Weeks | |
| One-year Survival Probability | Sunitinib + Erlotinib | 40.0 | 95% Confidence Interval 35.4 to 44.2 | Percent chance of survival | |
| One-year Survival Probability | Erlotinib | 37.0 | 95% Confidence Interval 32.8 to 41.6 | Percent chance of survival |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sunitinib + Erlotinib | 480 | |
| Overall Study | STARTED | Erlotinib | 480 | |
| Overall Study | Treated | Sunitinib + Erlotinib | 473 | |
| Overall Study | Treated | Erlotinib | 477 | |
| Overall Study | COMPLETED | Sunitinib + Erlotinib | 0 | |
| Overall Study | COMPLETED | Erlotinib | 0 | |
| Overall Study | NOT COMPLETED | Sunitinib + Erlotinib | 480 | |
| Overall Study | NOT COMPLETED | Erlotinib | 480 |
Source ClinicalTrials.gov
Adverse events1,806
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 | Anaemia | Blood and lymphatic system disorders | Sunitinib + Erlotinib | 51 | 473 | |
| other | Anaemia | Blood and lymphatic system disorders | Erlotinib | 23 | 477 | |
| other | Anaemia megaloblastic | Blood and lymphatic system disorders | Sunitinib + Erlotinib | 1 | 473 | |
| other | Anaemia megaloblastic | Blood and lymphatic system disorders | Erlotinib | 0 | 477 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Sunitinib + Erlotinib | 1 | 473 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Erlotinib | 0 | 477 | |
| other | Granulocytopenia | Blood and lymphatic system disorders | Sunitinib + Erlotinib | 2 | 473 | |
| other | Granulocytopenia | Blood and lymphatic system disorders | Erlotinib | 0 | 477 | |
| other | Haemorrhagic diathesis | Blood and lymphatic system disorders | Sunitinib + Erlotinib | 1 | 473 | |
| other | Haemorrhagic diathesis | Blood and lymphatic system disorders | Erlotinib | 0 | 477 |
1 to 10 of 1,806Source ClinicalTrials.gov
See all 1,806 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sunitinib + Erlotinib | ||
| Total, all-cause mortality | Erlotinib | ||
| Total, other adverse events | Sunitinib + Erlotinib | 463 | 473 |
| Total, other adverse events | Erlotinib | 461 | 477 |
| Total, serious adverse events | Sunitinib + Erlotinib | 207 | 473 |
| Total, serious adverse events | Erlotinib | 181 | 477 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Sunitinib + Erlotinib vs Erlotinib: serious adverse events |
Source Trial comparisons
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/NCT00457392
GET https://conductscience.org/api/trials/v1/NCT00457392/events?page=2