Trial · NCT00130728
A Study to Evaluate the Efficacy of Bevacizumab in Combination With Tarceva for Advanced Non-Small Cell Lung Cancer
NCT00130728, Phase 3, Completed, Genentech, Inc.; results first posted 2011-11-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Efficacy of Bevacizumab in Combination With Tarceva for Advanced Non-Small Cell Lung Cancer. Trials, record NCT00130728. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00130728
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy of Bevacizumab in Combination With Tarceva for Advanced Non-Small Cell Lung Cancer
- NCT number
- NCT00130728
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 636 participants, actual
- Lead sponsor
- Genentech, Inc.
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- bevacizumab, erlotinib HCl, placebo
- First posted
- 2005-08-16
- Last updated
- 2021-01-14
- Results first posted
- 2011-11-03
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) Among All Randomized Patients | From the date of randomization until the date of patient death from any cause, or the date of last contact. (Up to 3.1 years) | Overall Survival was defined as the period from the date of randomization until the date of patient death from any cause. For patients who had not died, survival data was censored at the date of last contact. |
| Secondary | Progression-free Survival (PFS) | From randomization to documented disease progression or death on study treatment, whichever occurred first. (Up to 3.1 years) | PFS was defined as the time from randomization to documented disease progression, as determined by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST), or death on study treatment, whichever occurred first. |
| Secondary | Percentage of Participants With Objective Response | The median duration of Objective response was up to 9.7 months | Objective response was defined as a complete or partial response determined by RECIST on two consecutive occasions \>= 4 weeks apart. |
| Secondary | Duration of Objective Response | Period from Objective response until disease progression or death on study treatment. (Up to 29.5 months) | Duration of objective response was defined as the period from the date of the initial partial or complete response until the date of disease progression or death on study treatment from any cause. For patients who had not died, data was censored at the date of last contact. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) Among All Randomized Patients | From the date of randomization until the date of patient death from any cause, or the date of last contact. (Up to 3.1 years) | Randomized patients | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | From randomization to documented disease progression or death on study treatment, whichever occurred first. (Up to 3.1 years) | Randomized patients | months | MEDIAN |
| SECONDARY | Percentage of Participants With Objective Response | The median duration of Objective response was up to 9.7 months | Only patients with measurable disease at baseline were included in the analysis of the objective response. Patients without a post-baseline tumor assessment were considered non-responder. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Objective Response | Period from Objective response until disease progression or death on study treatment. (Up to 29.5 months) | Patients with an objective response | months | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) Among All Randomized Patients | Erlotinib HCl + Bevacizumab | 9.3 | 95% Confidence Interval 7.39 to 11.47 | months | |
| Overall Survival (OS) Among All Randomized Patients | Erlotinib HCl + Placebo | 9.2 | 95% Confidence Interval 7.85 to 11.60 | months | |
| Progression-free Survival (PFS) | Erlotinib HCl + Bevacizumab | 3.4 | 95% Confidence Interval 2.79 to 4.27 | months | |
| Progression-free Survival (PFS) | Erlotinib HCl + Placebo | 1.7 | 95% Confidence Interval 1.48 to 2.53 | months | |
| Percentage of Participants With Objective Response | Erlotinib HCl + Bevacizumab | 12.6 | 95% Confidence Interval 9.1 to 16.8 | Percentage of participants | |
| Percentage of Participants With Objective Response | Erlotinib HCl + Placebo | 6.2 | 95% Confidence Interval 3.8 to 9.5 | Percentage of participants | |
| Duration of Objective Response | Erlotinib HCl + Bevacizumab | 9.7 | 95% Confidence Interval 6.90 to 19.48 | months | |
| Duration of Objective Response | Erlotinib HCl + Placebo | 8.4 | 95% Confidence Interval 3.48 to 14.88 | months |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Erlotinib HCl + Bevacizumab | 319 | |
| Overall Study | STARTED | Erlotinib HCl + Placebo | 317 | |
| Overall Study | Received Study Drug (Safety Population) | Erlotinib HCl + Bevacizumab | 313 | |
| Overall Study | Received Study Drug (Safety Population) | Erlotinib HCl + Placebo | 313 | |
| Overall Study | COMPLETED | Erlotinib HCl + Bevacizumab | 57 | |
| Overall Study | COMPLETED | Erlotinib HCl + Placebo | 57 | |
| Overall Study | NOT COMPLETED | Erlotinib HCl + Bevacizumab | 262 | |
| Overall Study | NOT COMPLETED | Erlotinib HCl + Placebo | 260 |
Source ClinicalTrials.gov
Adverse events438
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 | Erlotinib HCl + Bevacizumab | 19 | 313 | |
| other | Anaemia | Blood and lymphatic system disorders | Erlotinib HCl + Placebo | 29 | 313 | |
| other | Diarrhoea | Gastrointestinal disorders | Erlotinib HCl + Bevacizumab | 203 | 313 | |
| other | Diarrhoea | Gastrointestinal disorders | Erlotinib HCl + Placebo | 162 | 313 | |
| other | Nausea | Gastrointestinal disorders | Erlotinib HCl + Bevacizumab | 121 | 313 | |
| other | Nausea | Gastrointestinal disorders | Erlotinib HCl + Placebo | 99 | 313 | |
| other | Vomiting | Gastrointestinal disorders | Erlotinib HCl + Bevacizumab | 57 | 313 | |
| other | Vomiting | Gastrointestinal disorders | Erlotinib HCl + Placebo | 49 | 313 | |
| other | Constipation | Gastrointestinal disorders | Erlotinib HCl + Bevacizumab | 49 | 313 | |
| other | Constipation | Gastrointestinal disorders | Erlotinib HCl + Placebo | 45 | 313 |
1 to 10 of 438Source ClinicalTrials.gov
See all 438 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Erlotinib HCl + Bevacizumab | 258 | 313 |
| Total, all-cause mortality | Erlotinib HCl + Placebo | 258 | 313 |
| Total, other adverse events | Erlotinib HCl + Bevacizumab | 310 | 313 |
| Total, other adverse events | Erlotinib HCl + Placebo | 306 | 313 |
| Total, serious adverse events | Erlotinib HCl + Bevacizumab | 146 | 313 |
| Total, serious adverse events | Erlotinib HCl + Placebo | 121 | 313 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21621716 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Erlotinib HCl + Bevacizumab vs Erlotinib HCl + Placebo: deaths from any cause | Trial comparisons |
| Erlotinib HCl + Bevacizumab vs Erlotinib HCl + Placebo: serious adverse events | 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/NCT00130728
GET https://conductscience.org/api/trials/v1/NCT00130728/events?page=2