Trial · NCT00445848
S0636: Erlotinib and Bevacizumab in Never-Smokers With Stage IIIB or Stage IV Primary Non-Small Cell Lung Cancer
NCT00445848, Phase 2, Completed, SWOG Cancer Research Network; results first posted 2016-09-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. S0636: Erlotinib and Bevacizumab in Never-Smokers With Stage IIIB or Stage IV Primary Non-Small Cell Lung Cancer. Trials, record NCT00445848. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00445848
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- S0636: Erlotinib and Bevacizumab in Never-Smokers With Stage IIIB or Stage IV Primary Non-Small Cell Lung Cancer
- NCT number
- NCT00445848
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 89 participants, actual
- Lead sponsor
- SWOG Cancer Research Network
- Conditions
- Lung Cancer
- Interventions
- bevacizumab, erlotinib hydrochloride
- First posted
- 2007-03-09
- Last updated
- 2020-03-05
- Results first posted
- 2016-09-07
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 | Disease assessment is performed every 6 weeks for 18 weeks, then every 9-12 weeks until progression up to 2 years. After disease progression, patients must be followed every 3 months for 1 year and then every 6 months for a maximum of 3 years. | From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. |
| Secondary | Progression-free Survival | Disease assessment is performed every 6 weeks for 18 weeks, then every 9-12 weeks until progression up to 2 years. After disease progression, patients must be followed every 3 months for 1 year and then every 6 months for a maximum of 3 years. | From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.0), as a 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, or unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided) or appearance of any new lesion/site, or death due to disease without prior documentation of progression and without symptomatic deterioration. |
| Secondary | Response Rate (Complete and Partial) | Disease assessment is performed every 6 weeks for 18 weeks, then every 9-12 weeks until progression up to 2 years. After disease progression, patients must be followed every 3 months for 1 year and then every 6 months for a maximum of 3 years. | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0): Complete Response (CR), Disappearance of all measurable and non-measurable disease; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. All target measurable lesions must be assessed using the same techniques as baseline. |
| Secondary | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy. | Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included. |
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 | Disease assessment is performed every 6 weeks for 18 weeks, then every 9-12 weeks until progression up to 2 years. After disease progression, patients must be followed every 3 months for 1 year and then every 6 months for a maximum of 3 years. | months | MEDIAN | |
| SECONDARY | Progression-free Survival | Disease assessment is performed every 6 weeks for 18 weeks, then every 9-12 weeks until progression up to 2 years. After disease progression, patients must be followed every 3 months for 1 year and then every 6 months for a maximum of 3 years. | months | MEDIAN | |
| SECONDARY | Response Rate (Complete and Partial) | Disease assessment is performed every 6 weeks for 18 weeks, then every 9-12 weeks until progression up to 2 years. After disease progression, patients must be followed every 3 months for 1 year and then every 6 months for a maximum of 3 years. | Only patients with measurable disease at baseline were included in the analysis. 66 of 85 patients (78%) had measurable disease at baseline. | participants | NUMBER |
| SECONDARY | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy. | Eligible patients who had received the protocol treatments were included in the adverse event summaries. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Erlotinib and Bevacizumab | 29.8 | 95% Confidence Interval 22.5 to 37.8 | months | |
| Progression-free Survival | Erlotinib and Bevacizumab | 7.4 | 95% Confidence Interval 6.1 to 10.9 | months | |
| Response Rate (Complete and Partial) | Erlotinib and Bevacizumab | Complete Response (CR) | 2 | participants | |
| Response Rate (Complete and Partial) | Erlotinib and Bevacizumab | Partial Response (PR) | 31 | participants | |
| Response Rate (Complete and Partial) | Erlotinib and Bevacizumab | Objective Response Rate (CR + PR) | 33 | participants | |
| Response Rate (Complete and Partial) | Erlotinib and Bevacizumab | Stable Disease (SD) | 23 | participants | |
| Response Rate (Complete and Partial) | Erlotinib and Bevacizumab | Non-Progression (ORR+SD) | 56 | participants | |
| Response Rate (Complete and Partial) | Erlotinib and Bevacizumab | Progressive Disease (PD) | 8 | participants | |
| Response Rate (Complete and Partial) | Erlotinib and Bevacizumab | Not Determinable/ Inadequate Assessment | 2 | participants | |
| Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Erlotinib and Bevacizumab | ALT, SGPT (serum glutamic pyruvic transaminase) | 3 | Participants |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Erlotinib and Bevacizumab | 85 | |
| Overall Study | COMPLETED | Erlotinib and Bevacizumab | 0 | |
| Overall Study | NOT COMPLETED | Erlotinib and Bevacizumab | 85 |
Source ClinicalTrials.gov
Adverse events111
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 | Hemoglobin | Blood and lymphatic system disorders | Erlotinib and Bevacizumab | 19 | 85 | |
| other | Dry eye syndrome | Eye disorders | Erlotinib and Bevacizumab | 9 | 85 | |
| other | Ocular/Visual-Other | Eye disorders | Erlotinib and Bevacizumab | 6 | 85 | |
| other | Watery eye (epiphora, tearing) | Eye disorders | Erlotinib and Bevacizumab | 6 | 85 | |
| other | Constipation | Gastrointestinal disorders | Erlotinib and Bevacizumab | 13 | 85 | |
| other | Diarrhea | Gastrointestinal disorders | Erlotinib and Bevacizumab | 62 | 85 | |
| other | Dry mouth/salivary gland (xerostomia) | Gastrointestinal disorders | Erlotinib and Bevacizumab | 14 | 85 | |
| other | Flatulence | Gastrointestinal disorders | Erlotinib and Bevacizumab | 6 | 85 | |
| other | Heartburn/dyspepsia | Gastrointestinal disorders | Erlotinib and Bevacizumab | 13 | 85 | |
| other | Hemorrhage, GI - Oral cavity | Gastrointestinal disorders | Erlotinib and Bevacizumab | 7 | 85 |
1 to 10 of 111Source ClinicalTrials.gov
See all 111 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Erlotinib and Bevacizumab | ||
| Total, other adverse events | Erlotinib and Bevacizumab | 83 | 85 |
| Total, serious adverse events | Erlotinib and Bevacizumab | 17 | 85 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA032102 | Southwest Oncology Group Treatment Grant | BLANKE, CHARLES D. | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
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/NCT00445848
GET https://conductscience.org/api/trials/v1/NCT00445848/results?page=2