Trial · NCT00946712
S0819: Carboplatin and Paclitaxel With or Without Bevacizumab and/or Cetuximab in Treating Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer
NCT00946712, Phase 3, Terminated, SWOG Cancer Research Network; results first posted 2019-03-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. S0819: Carboplatin and Paclitaxel With or Without Bevacizumab and/or Cetuximab in Treating Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer. Trials, record NCT00946712. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00946712
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- S0819: Carboplatin and Paclitaxel With or Without Bevacizumab and/or Cetuximab in Treating Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer
- NCT number
- NCT00946712
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,333 participants, actual
- Lead sponsor
- SWOG Cancer Research Network
- Conditions
Recurrent Large Cell Lung Carcinoma, Recurrent Lung Adenocarcinoma, Recurrent Squamous Cell Lung Carcinoma, Stage IV Large Cell Lung Carcinoma, Stage IV Lung Adenocarcinoma, Stage IV Squamous Cell Lung Carcinoma
- Interventions
- Bevacizumab, Carboplatin, Cetuximab, Laboratory Biomarker Analysis, Paclitaxel
- First posted
- 2009-07-27
- Last updated
- 2023-05-23
- Results first posted
- 2019-03-07
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) in the Entire Study Population | Patients will be followed every 3 weeks while on protocol treatment. Once off all protocol treatment, patients will be followed every 6 months until death or up to 3 years | From date of randomization to date of death due to any cause. Patients last known to be alive are censored at date of last contact. |
| Primary | Progression-free Survival (PFS) of EGFR FISH-positive Patients by Institutional Review | Disease assessment will be repeated every 6 weeks for the first 9 months and every 3 months thereafter, until disease progression. | From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause, whichever comes first by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as assessed by the treating investigator.Patients last known to be alive and progression-free are censored at date of last contact. Progression is defined using RECIST 1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Overall Survival (OS) of EGFR FISH-positive Patients | Patients will be followed every 3 weeks while on protocol treatment. Once off all protocol treatment, patients will be followed every 6 months until death or up to 3 years | From date of randomization 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 (PFS) of EGFR FISH-positive Patients by Centralized Review | Disease assessment will be repeated every 6 weeks until disease progression while on treatment. After off treatment, the frequency of disease assessment may be reduced to every 3 months until disease progression. | From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause, whichever comes first by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as assessed by the treating investigator.Patients last known to be alive and progression-free are censored at date of last contact. Progression is defined using RECIST 1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Progression-Free Survival (PFS) of the Entire Study Population by Institutional Review | Disease assessment will be repeated every 6 weeks until disease progression while on treatment. After off treatment, the frequency of disease assessment may be reduced to every 3 months until disease progression. | From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause, whichever comes first by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as assessed by the treating investigator.Patients last known to be alive and progression-free are censored at date of last contact. Progression is defined using RECIST 1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Progression-Free Survival (PFS) of the Entire Study Population by Centralized Review | Disease assessment will be repeated every 6 weeks until disease progression while on treatment. After off treatment, the frequency of disease assessment may be reduced to every 3 months until disease progression. | From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause, whichever comes first by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as assessed by the treating investigator.Patients last known to be alive and progression-free are censored at date of last contact. Progression is defined using RECIST 1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Response Rate (Confirmed Plus Unconfirmed, Complete and Partial Responses) in the Subset of Patients With Measurable Disease in EGFR FISH-positive Patients | Disease assessment will be repeated every 6 weeks for the first 9 months and every 3 months thereafter, until disease progression. | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR |
| Secondary | Response Rate (Confirmed Plus Unconfirmed, Complete and Partial Responses) in the Subset of Patients With Measurable Disease in the Entire Study Population | Disease assessment will be repeated every 6 weeks for the first 9 months and every 3 months thereafter, until disease progression. | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Secondary | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Toxicity assessment was evaluated every 3 weeks while one protocol treatment. Chemo and cetuximab is treated for 6 cycles (1 cycle =3 weeks) and Bevacizumab is treated until progression or unacceptable toxicity. | Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. |
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 | Overall Survival (OS) in the Entire Study Population | Patients will be followed every 3 weeks while on protocol treatment. Once off all protocol treatment, patients will be followed every 6 months until death or up to 3 years | All eligible patients are included in the analysis. | months | MEDIAN |
| PRIMARY | Progression-free Survival (PFS) of EGFR FISH-positive Patients by Institutional Review | Disease assessment will be repeated every 6 weeks for the first 9 months and every 3 months thereafter, until disease progression. | Eligible patients with EGFR FISH positive are included in the analysis. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) of EGFR FISH-positive Patients | Patients will be followed every 3 weeks while on protocol treatment. Once off all protocol treatment, patients will be followed every 6 months until death or up to 3 years | Eligible and evaluable participants who were EGFR-FISH positive | Months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) of EGFR FISH-positive Patients by Centralized Review | Disease assessment will be repeated every 6 weeks until disease progression while on treatment. After off treatment, the frequency of disease assessment may be reduced to every 3 months until disease progression. | Data are not available for this outcome as central image review was not performed. The study was closed for futility at the interim analysis and therefore there was no need to confirm PFS by central review. | ||
| SECONDARY | Progression-Free Survival (PFS) of the Entire Study Population by Institutional Review | Disease assessment will be repeated every 6 weeks until disease progression while on treatment. After off treatment, the frequency of disease assessment may be reduced to every 3 months until disease progression. | Eligible and evaluable participants | Months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) of the Entire Study Population by Centralized Review | Disease assessment will be repeated every 6 weeks until disease progression while on treatment. After off treatment, the frequency of disease assessment may be reduced to every 3 months until disease progression. | Data are not available for this outcome as central image review was not performed. The study was closed for futility at the interim analysis and therefore there was no need to confirm PFS by central review. | ||
| SECONDARY | Response Rate (Confirmed Plus Unconfirmed, Complete and Partial Responses) in the Subset of Patients With Measurable Disease in EGFR FISH-positive Patients | Disease assessment will be repeated every 6 weeks for the first 9 months and every 3 months thereafter, until disease progression. | Eligible EGFR FISH positive patients with baseline measurable disease are included in the analysis. | percentage of analyzed participants | NUMBER |
| SECONDARY | Response Rate (Confirmed Plus Unconfirmed, Complete and Partial Responses) in the Subset of Patients With Measurable Disease in the Entire Study Population | Disease assessment will be repeated every 6 weeks for the first 9 months and every 3 months thereafter, until disease progression. | Eligible patients with baseline measurable disease are included in the analysis. | percentage of analyzed participants | NUMBER |
| SECONDARY | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Toxicity assessment was evaluated every 3 weeks while one protocol treatment. Chemo and cetuximab is treated for 6 cycles (1 cycle =3 weeks) and Bevacizumab is treated until progression or unacceptable toxicity. | Limited to eligible patients who started treatment, who did not have a major deviation in the treatment protocol, and whose toxicity profile has been completed. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group422
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) in the Entire Study Population | Arm I (Chemo +/- Bevacizumab) | 9.2 | 95% Confidence Interval 8.7 to 10.3 | months | |
| Overall Survival (OS) in the Entire Study Population | Arm II (Chemo, Cetuximab, +/- Bevacizumab) | 10.9 | 95% Confidence Interval 9.5 to 12.0 | months | |
| Progression-free Survival (PFS) of EGFR FISH-positive Patients by Institutional Review | Arm I (Chemo +/- Bevacizumab) | 4.8 | 95% Confidence Interval 3.9 to 5.5 | months | |
| Progression-free Survival (PFS) of EGFR FISH-positive Patients by Institutional Review | Arm II (Chemo, Cetuximab, +/- Bevacizumab) | 5.4 | 95% Confidence Interval 4.5 to 5.7 | months | |
| Overall Survival (OS) of EGFR FISH-positive Patients | Arm I (Chemo +/- Bevacizumab) | 9.8 | 95% Confidence Interval 8.7 to 12.1 | Months | |
| Overall Survival (OS) of EGFR FISH-positive Patients | Arm II (Chemo, Cetuximab, +/- Bevacizumab) | 13.4 | 95% Confidence Interval 11.5 to 14.8 | Months | |
| Progression-Free Survival (PFS) of the Entire Study Population by Institutional Review | Arm I (Chemo +/- Bevacizumab) | 4.5 | 95% Confidence Interval 4.2 to 5.1 | Months | |
| Progression-Free Survival (PFS) of the Entire Study Population by Institutional Review | Arm II (Chemo, Cetuximab, +/- Bevacizumab) | 4.6 | 95% Confidence Interval 4.2 to 5.2 | Months | |
| Response Rate (Confirmed Plus Unconfirmed, Complete and Partial Responses) in the Subset of Patients With Measurable Disease in EGFR FISH-positive Patients | Arm I (Chemo +/- Bevacizumab) | 43 | 95% Confidence Interval 36 to 50 | percentage of analyzed participants | |
| Response Rate (Confirmed Plus Unconfirmed, Complete and Partial Responses) in the Subset of Patients With Measurable Disease in EGFR FISH-positive Patients | Arm II (Chemo, Cetuximab, +/- Bevacizumab) | 47 | 95% Confidence Interval 39 to 54 | percentage of analyzed participants |
1 to 10 of 422Source ClinicalTrials.gov
See all 422 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Chemo +/- Bevacizumab) | 671 | |
| Overall Study | STARTED | Arm II (Chemo, Cetuximab, +/- Bevacizumab) | 662 | |
| Overall Study | COMPLETED | Arm I (Chemo +/- Bevacizumab) | 124 | |
| Overall Study | COMPLETED | Arm II (Chemo, Cetuximab, +/- Bevacizumab) | 0 | |
| Overall Study | NOT COMPLETED | Arm I (Chemo +/- Bevacizumab) | 547 | |
| Overall Study | NOT COMPLETED | Arm II (Chemo, Cetuximab, +/- Bevacizumab) | 662 |
Source ClinicalTrials.gov
Adverse events296
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 | Arm I (Chemo +/- Bevacizumab) | 434 | 632 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Arm II (Chemo, Cetuximab, +/- Bevacizumab) | 384 | 627 | |
| other | Vision-blurred vision | Eye disorders | Arm I (Chemo +/- Bevacizumab) | 38 | 632 | |
| other | Vision-blurred vision | Eye disorders | Arm II (Chemo, Cetuximab, +/- Bevacizumab) | 33 | 627 | |
| other | Constipation | Gastrointestinal disorders | Arm I (Chemo +/- Bevacizumab) | 261 | 632 | |
| other | Constipation | Gastrointestinal disorders | Arm II (Chemo, Cetuximab, +/- Bevacizumab) | 302 | 627 | |
| other | Diarrhea | Gastrointestinal disorders | Arm I (Chemo +/- Bevacizumab) | 195 | 632 | |
| other | Diarrhea | Gastrointestinal disorders | Arm II (Chemo, Cetuximab, +/- Bevacizumab) | 243 | 627 | |
| other | Heartburn/dyspepsia | Gastrointestinal disorders | Arm I (Chemo +/- Bevacizumab) | 70 | 632 | |
| other | Heartburn/dyspepsia | Gastrointestinal disorders | Arm II (Chemo, Cetuximab, +/- Bevacizumab) | 109 | 627 |
1 to 10 of 296Source ClinicalTrials.gov
See all 296 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Chemo +/- Bevacizumab) | 593 | 657 |
| Total, all-cause mortality | Arm II (Chemo, Cetuximab, +/- Bevacizumab) | 570 | 656 |
| Total, other adverse events | Arm I (Chemo +/- Bevacizumab) | 619 | 632 |
| Total, other adverse events | Arm II (Chemo, Cetuximab, +/- Bevacizumab) | 611 | 627 |
| Total, serious adverse events | Arm I (Chemo +/- Bevacizumab) | 66 | 632 |
| Total, serious adverse events | Arm II (Chemo, Cetuximab, +/- Bevacizumab) | 97 | 627 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| U10CA180888 | SWOG Network Group Operations Center of the NCTN | LARA, PRIMO N.; HERSHMAN, DAWN | UNIVERSITY OF CALIFORNIA AT DAVIS | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA032102 | Southwest Oncology Group Treatment Grant | BLANKE, CHARLES D. | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I (Chemo +/- Bevacizumab) vs Arm II (Chemo, Cetuximab, +/- Bevacizumab): deaths from any cause | Trial comparisons |
| Arm I (Chemo +/- Bevacizumab) vs Arm II (Chemo, Cetuximab, +/- Bevacizumab): 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/NCT00946712
GET https://conductscience.org/api/trials/v1/NCT00946712/results?page=2