Trial · NCT00103207
Cetuximab in Treating Patients With Recurrent or Stage IIIB or Stage IV Lung Cancer
NCT00103207, Phase 2, Completed, Eastern Cooperative Oncology Group; results first posted 2013-01-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cetuximab in Treating Patients With Recurrent or Stage IIIB or Stage IV Lung Cancer. Trials, record NCT00103207. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00103207
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cetuximab in Treating Patients With Recurrent or Stage IIIB or Stage IV Lung Cancer
- NCT number
- NCT00103207
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 72 participants, actual
- Lead sponsor
- Eastern Cooperative Oncology Group
- Conditions
- Lung Cancer
- Interventions
- cetuximab
- First posted
- 2005-02-08
- Last updated
- 2023-06-28
- Results first posted
- 2013-01-04
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (Proportion of Patients With Objective Response) | Assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years | Response was evaluated using RECIST 1.0 criteria. Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= \>=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR. |
| Secondary | Overall Survival | Every week during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years | Overall survival is defined as the time from registration to death. |
| Secondary | Time to Progression | Assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years | Time to progression is defined as time from study entry until disease progression. Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions. |
| Secondary | Overall Survival by Smoking Status | Overall survival assessed every week during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years. Smoking status evaluated at baseline | Medians of overall survival by smoking status are reported. |
| Secondary | Time to Progression by Smoking Status | Progression assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years. Smoking status evaluated at baseline | Medians of time to progression by smoking status are reported. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (Proportion of Patients With Objective Response) | Assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years | Only eligible and treated patients with confirmed diagnosis are included in this analysis. | Proportion | NUMBER |
| SECONDARY | Overall Survival | Every week during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years | Only eligible and treated patients with confirmed diagnosis are included. | Months | MEDIAN |
| SECONDARY | Time to Progression | Assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years | Only eligible and treated patients with confirmed diagnosis are included in the analysis. | Months | MEDIAN |
| SECONDARY | Overall Survival by Smoking Status | Overall survival assessed every week during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years. Smoking status evaluated at baseline | Only eligible and treated patients with confirmed diagnosis and smoking status data are included in the analysis. | Months | MEDIAN |
| SECONDARY | Time to Progression by Smoking Status | Progression assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years. Smoking status evaluated at baseline | Only eligible and treated patients with confirmed diagnosis and smoking status data are included in the analysis. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (Proportion of Patients With Objective Response) | Cetuximab | 0.07 | 90% Confidence Interval 0.02 to 0.18 | Proportion | |
| Overall Survival | Cetuximab | 17.9 | 95% Confidence Interval 10.6 to 31.5 | Months | |
| Time to Progression | Cetuximab | 3.8 | 95% Confidence Interval 2.6 to 5.7 | Months | |
| Overall Survival by Smoking Status | Never Smoker | 40.9 | 95% Confidence Interval 7.2 to NA | Months | |
| Overall Survival by Smoking Status | Former/Current Smoker | 15.5 | 95% Confidence Interval 8.9 to 30.2 | Months | |
| Time to Progression by Smoking Status | Never Smoker | 2.6 | 95% Confidence Interval 1.8 to 6.0 | Months | |
| Time to Progression by Smoking Status | Former/Current Smoker | 3.7 | 95% Confidence Interval 2.6 to 5.7 | Months |
Source ClinicalTrials.gov
Participant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cetuximab | 72 | |
| Overall Study | Eligible Patients w/ Confirmed Diagnosis | Cetuximab | 41 | |
| Overall Study | Eligible Patients w/ Smoking Status Data | Cetuximab | 37 | |
| Overall Study | COMPLETED | Cetuximab | 34 | |
| Overall Study | NOT COMPLETED | Cetuximab | 38 |
Source ClinicalTrials.gov
Adverse events74
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 | Allergic reaction | Immune system disorders | Cetuximab | 4 | 72 | |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Cetuximab | 5 | 72 | |
| other | Anemia | Blood and lymphatic system disorders | Cetuximab | 27 | 72 | |
| other | Leukocytes, decreased | Investigations | Cetuximab | 8 | 72 | |
| other | Neutrophils, decreased | Investigations | Cetuximab | 7 | 72 | |
| other | Platelets, decreased | Investigations | Cetuximab | 5 | 72 | |
| other | Fatigue | General disorders | Cetuximab | 44 | 72 | |
| other | Fever w/o neutropenia | General disorders | Cetuximab | 8 | 72 | |
| other | Rigors/chills | General disorders | Cetuximab | 4 | 72 | |
| other | Weight loss | Investigations | Cetuximab | 12 | 72 |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cetuximab | ||
| Total, other adverse events | Cetuximab | 70 | 72 |
| Total, serious adverse events | Cetuximab | 27 | 72 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21422434 | RESULT |
Source PubMed
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 |
|---|---|---|---|---|---|
| U10CA021115 | Eastern Cooperative Oncology Group Operations Office | COMIS, ROBERT L | FRONTIER SCI & TECHNOLOGY RSCH FDN, INC | 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/NCT00103207
GET https://conductscience.org/api/trials/v1/NCT00103207/events?page=2