Trial · NCT00148798
Study of Cisplatin/Vinorelbine +/- Cetuximab as First-line Treatment of Advanced Non Small Cell Lung Cancer (FLEX)
NCT00148798, Phase 3, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2011-10-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Cisplatin/Vinorelbine +/- Cetuximab as First-line Treatment of Advanced Non Small Cell Lung Cancer (FLEX). Trials, record NCT00148798. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00148798
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Cisplatin/Vinorelbine +/- Cetuximab as First-line Treatment of Advanced Non Small Cell Lung Cancer (FLEX)
- NCT number
- NCT00148798
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,861 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Non Small Cell Lung Cancer (NSCLC)
- Interventions
- cetuximab + cisplatin + vinorelbine, cisplatin + vinorelbine
- First posted
- 2005-09-08
- Last updated
- 2014-06-25
- Results first posted
- 2011-10-04
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival Time (OS) | Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007 | Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier. |
| Secondary | Progression-free Survival Time | Time from randomization to disease progression, death or last tumor assessment, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007 | Duration from randomization until radiological progression (based on modified World Health Organisation (WHO) criteria) or death due to any cause. Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment. |
| Secondary | Best Overall Response Rate | Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007 | The best overall response rate is defined as the proportion of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria). |
| Secondary | Disease Control Rate | Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007 | The disease control rate is defined as the proportion of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments (based on modified WHO criteria). |
| Secondary | Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status | at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007 | Mean global health status scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL. |
| Secondary | Quality of Life Assessment (EORTC QLQ-C30) Social Functioning | at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007 | Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of functioning. |
| Secondary | A Population Pharmacokinetic (PK) Analysis for Cetuximab in Non-Small Cell Lung Cancer (NSCLC) - Serum Cetuximab Concentrations | Week 1, Day 1: baseline and end of infusion; Week 7, Day 43: within 12 h after cetuximab administration. | Population PK analysis was conducted using non-linear mixed effects modeling (NONMEM) software, integrating the PK data from this study and the Phase II study EMR 62 202-011. |
| Secondary | Safety - Number of Patients Experiencing Any Adverse Event | time from first dose up to 30 after last dose of study treatment, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007 | Please refer to Adverse Events section for further details |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival Time (OS) | Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007 | ITT | months | MEDIAN |
| SECONDARY | Progression-free Survival Time | Time from randomization to disease progression, death or last tumor assessment, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007 | ITT | months | MEDIAN |
| SECONDARY | Best Overall Response Rate | Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007 | percentage of participants | NUMBER | |
| SECONDARY | Disease Control Rate | Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007 | ITT | percentage of participants | NUMBER |
| SECONDARY | Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status | at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007 | 670 subjects completed (348 in the cetuximab + chemotherapy arm and 322 in the chemotherapy alone arm) at least 1 evaluable QLQ-C30 questionnaire and were included in the Evaluable population. Numbers at each timepoint were (Cetuximab + chemotherapy/Chemotherapy alone, respectively): baseline 278/274; cycle 3 184/153; 6 month 102/96 | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Quality of Life Assessment (EORTC QLQ-C30) Social Functioning | at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007 | 670 subjects completed (348 in the cetuximab + chemotherapy arm and 322 in the chemotherapy alone arm) at least 1 evaluable QLQ-C30 questionnaire and were included in the Evaluable population. Numbers at each timepoint were (Cetuximab + chemotherapy/Chemotherapy alone, respectively): baseline 280/275; cycle 3 185/153; 6 month 101/97 | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | A Population Pharmacokinetic (PK) Analysis for Cetuximab in Non-Small Cell Lung Cancer (NSCLC) - Serum Cetuximab Concentrations | Week 1, Day 1: baseline and end of infusion; Week 7, Day 43: within 12 h after cetuximab administration. | ug/mL | MEAN | |
| SECONDARY | Safety - Number of Patients Experiencing Any Adverse Event | time from first dose up to 30 after last dose of study treatment, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007 | Safety Population | participants | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival Time (OS) | Cetuximab Plus Chemotherapy | 11.3 | 95% Confidence Interval 9.4 to 12.4 | months | |
| Overall Survival Time (OS) | Chemotherapy Alone | 10.1 | 95% Confidence Interval 9.1 to 10.9 | months | |
| Progression-free Survival Time | Cetuximab Plus Chemotherapy | 4.8 | 95% Confidence Interval 4.2 to 5.3 | months | |
| Progression-free Survival Time | Chemotherapy Alone | 4.8 | 95% Confidence Interval 4.4 to 5.4 | months | |
| Best Overall Response Rate | Cetuximab Plus Chemotherapy | 36.4 | 95% Confidence Interval 32.4 to 40.6 | percentage of participants | |
| Best Overall Response Rate | Chemotherapy Alone | 29.2 | 95% Confidence Interval 25.5 to 33.2 | percentage of participants | |
| Disease Control Rate | Cetuximab Plus Chemotherapy | 72.5 | 95% Confidence Interval 68.6 to 76.2 | percentage of participants | |
| Disease Control Rate | Chemotherapy Alone | 71.5 | 95% Confidence Interval 67.6 to 75.2 | percentage of participants | |
| Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status | Cetuximab Plus Chemotherapy | At baseline | 45.72 | Standard Error 2.164 | scores on a scale |
| Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status | Chemotherapy Alone | At baseline | 46.36 | Standard Error 2.138 | scores on a scale |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cetuximab Plus Chemotherapy | 557 | |
| Overall Study | STARTED | Chemotherapy Alone | 568 | |
| Overall Study | COMPLETED | Cetuximab Plus Chemotherapy | 557 | |
| Overall Study | COMPLETED | Chemotherapy Alone | 568 | |
| Overall Study | NOT COMPLETED | Cetuximab Plus Chemotherapy | 0 | |
| Overall Study | NOT COMPLETED | Chemotherapy Alone | 0 |
Source ClinicalTrials.gov
Adverse events616
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 | Neutropenia | Blood and lymphatic system disorders | Cetuximab Plus Chemotherapy | 302 | 548 | |
| other | Neutropenia | Blood and lymphatic system disorders | Chemotherapy Alone | 324 | 562 | |
| other | Anaemia | Blood and lymphatic system disorders | Cetuximab Plus Chemotherapy | 226 | 548 | |
| other | Anaemia | Blood and lymphatic system disorders | Chemotherapy Alone | 264 | 562 | |
| other | Leukopenia | Blood and lymphatic system disorders | Cetuximab Plus Chemotherapy | 176 | 548 | |
| other | Leukopenia | Blood and lymphatic system disorders | Chemotherapy Alone | 155 | 562 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Cetuximab Plus Chemotherapy | 36 | 548 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Chemotherapy Alone | 32 | 562 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cetuximab Plus Chemotherapy | 23 | 548 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Chemotherapy Alone | 30 | 562 |
1 to 10 of 616Source ClinicalTrials.gov
See all 616 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cetuximab Plus Chemotherapy | ||
| Total, all-cause mortality | Chemotherapy Alone | ||
| Total, other adverse events | Cetuximab Plus Chemotherapy | 532 | 548 |
| Total, other adverse events | Chemotherapy Alone | 537 | 562 |
| Total, serious adverse events | Cetuximab Plus Chemotherapy | 325 | 548 |
| Total, serious adverse events | Chemotherapy Alone | 244 | 562 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|
| Cetuximab Plus Chemotherapy vs Chemotherapy Alone: Safety - Number of Patients Experiencing Any Adverse Event | Trial comparisons |
| Cetuximab Plus Chemotherapy vs Chemotherapy Alone: 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/NCT00148798
GET https://conductscience.org/api/trials/v1/NCT00148798/results?page=2