Trial · NCT00095199
Docetaxel or Pemetrexed With or Without Cetuximab in Patients With Recurrent or Progressive Non-Small Cell Lung Cancer
NCT00095199, Phase 3, Completed, Eli Lilly and Company; results first posted 2012-10-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Docetaxel or Pemetrexed With or Without Cetuximab in Patients With Recurrent or Progressive Non-Small Cell Lung Cancer. Trials, record NCT00095199. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00095199
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Docetaxel or Pemetrexed With or Without Cetuximab in Patients With Recurrent or Progressive Non-Small Cell Lung Cancer
- NCT number
- NCT00095199
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 939 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Pemetrexed, Cetuximab, Docetaxel
- First posted
- 2004-11-02
- Last updated
- 2012-10-15
- Results first posted
- 2012-10-15
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | Randomization to progression of disease or death due to any cause up to 59.6 months | PFS was defined as the time from randomization until the date of progressive disease (PD) or death from any cause. Participants who were alive and without progression were censored at the date of their last tumor assessment. PFS was assessed by the independent review committee (IRC) in the Pemetrexed group (Cetuximab \& Pemetrexed versus Pemetrexed) and by the investigator in the Docetaxel group (Cetuximab \& Docetaxel versus Docetaxel). |
| Secondary | Overall Survival (OS) | Randomization to the date of death from any cause up to 72.8 months | OS was defined as the time from randomization to death. Participants without a date of death were censored on the last date participants were known to be alive, or lost to follow-up. |
| Secondary | Proportion of Randomized Participants With the Best Overall Response (OR) of Partial Response (PR) or Complete Response (CR) (Overall Response Rate [ORR]) | Randomization until progression of disease or death from any cause up to 59.6 months | The best overall response rate (ORR) was the proportion of randomized participants with a best OR of CR or PR, according to modified World Health Organization (WHO) guidelines. It was calculated as the total number of participants with CR or PR divided by the total number of participants treated in that arm. Participants with no post-baseline evaluation were considered as non-responders. The tumor response was assessed by the independent review committee (IRC) in the Pemetrexed group and by the investigator in the Docetaxel group. |
| Secondary | Proportion of Randomized Participants With Best Overall Response (OR) of Partial Response (PR), Complete Response (CR), or Stable Disease (SD) | Randomization to progression of disease or death due to any cause up to 59.6 months | The disease control rate (DCR) was the proportion of randomized participants with a best OR of CR, PR or SD according to modified World Health Organization (WHO) guidelines. It was calculated as the total number of participants with CR, PR or SD divided by the total number of participants randomized in that arm. The tumor response was assessed by the independent review committee (IRC) in the Pemetrexed group and by the investigator in the Docetaxel group. |
| Secondary | Percentage of Participants With Symptomatic Response (Symptom Response Rates) Using the Lung Cancer Subscale (LCS) Scores of Functional Assessment of Cancer Therapy for Participants With Lung Cancer (FACT-L) | At baseline, every 3 weeks and 30 days after end of therapy up to 50 months | The FACT-LCS is a set of 7 questions to inventory problems specific to lung cancer symptoms. Participants rate each item on a 5-point Likert-type scale from 0 (not at all) to 4 (very much). Scores range from 0-28 and higher score indicates fewer symptoms. Symptom response (improvement) was defined as ≥2 point increase from baseline in the 7-item LCS score that was maintained for 2 consecutive assessments at least 3 weeks, and not \>5 weeks apart for participants, whose baseline LCS score was ≤26. Symptom response rate was the percentage of participants with symptomatic response. |
| Secondary | Time to Symptomatic Progression | Randomization until symptomatic progression up to 48.3 months | The FACT-LCS (see description in Outcome measure 5) inventories problems specific to lung cancer symptoms. Using this Scale, Symptom progression = a ≥ 2 point decrease from baseline in LCS score maintained for 2 consecutive assessments ≥3 weeks, and \<5 weeks, apart. The symptom progression date = the first of 2 consecutive assessments with a ≥2 point decline. Time to symptomatic progression = the time from randomization to the symptom progression date. For participants with no symptom progression, time to symptomatic progression was censored the date of last symptom assessment. |
| Secondary | Duration of Overall Response (OR) | Time of first occurrence of either (PR) or (CR) to the first date of progressive disease or death up to 32.5 months | The duration of response, in participants with best OR of complete response (CR) or partial response (PR), was measured from the date criteria are met for CR/PR (not confirmation date, whichever was first recorded), until the first occurrence date that the criteria of progressive disease (PD) was met, or death. Participants who were alive and without progression were censored at the date of their last independent review committee (IRC) tumor assessment. The tumor response and progression were assessed by the IRC in the Pemetrexed group and by the investigator in the Docetaxel group. |
| Secondary | Number of Participants With Common Toxicity Criteria (CTC) Grade 3 or 4 Toxicities | Time from first dose to 30 days after last dose of study therapy up to 28.3 months for Cetuximab & Pemetrexed (versus Pemetrexed alone) and up to 54.3 months for Cetuximab + Docetaxel (versus Docetaxel alone) | National Cancer Institutes-Common Toxicity Criteria version 3.0 was used by investigators to assess participant toxicities. Mapping of investigator verbatim terms to CTCAE terms was done by the sponsor/designee using CTCAE v4.0. Participants reported had grade 3 or 4 toxicities (or both potentially). Grade 3 AEs: severe or medically significant but not immediately life-threatening;hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4 AEs: life-threatening consequences; urgent intervention indicated. |
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 | Progression Free Survival (PFS) | Randomization to progression of disease or death due to any cause up to 59.6 months | The intent-to-treat population (ITT) included all participants classified according to the treatment arms into which they were randomized, regardless of the actual treatment received. Censored participants: 10 in Cetuximab + Pemetrexed arm; 25 in Pemetrexed arm; 6 in Cetuximab + Docetaxel arm; 16 in Docetaxel arm. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Randomization to the date of death from any cause up to 72.8 months | The intent-to-treat population (ITT) included all participants classified according to the treatment arms into which they were randomized, regardless of the actual treatment received. Censored participants: 24 in Cetuximab + Pemetrexed arm; 43 in Pemetrexed arm; 12 in Cetuximab + Docetaxel arm; 22 in Docetaxel arm. | months | MEDIAN |
| SECONDARY | Proportion of Randomized Participants With the Best Overall Response (OR) of Partial Response (PR) or Complete Response (CR) (Overall Response Rate [ORR]) | Randomization until progression of disease or death from any cause up to 59.6 months | The intent-to-treat population (ITT) included all participants classified according to the treatment arms into which they were randomized, regardless of the actual treatment received. | proportion of participants | NUMBER |
| SECONDARY | Proportion of Randomized Participants With Best Overall Response (OR) of Partial Response (PR), Complete Response (CR), or Stable Disease (SD) | Randomization to progression of disease or death due to any cause up to 59.6 months | The intent-to-treat population (ITT) included all participants classified according to the treatment arms into which they were randomized, regardless of the actual treatment received. | proportion of participants | NUMBER |
| SECONDARY | Percentage of Participants With Symptomatic Response (Symptom Response Rates) Using the Lung Cancer Subscale (LCS) Scores of Functional Assessment of Cancer Therapy for Participants With Lung Cancer (FACT-L) | At baseline, every 3 weeks and 30 days after end of therapy up to 50 months | The randomized participants with baseline LCS scores less than or equal to 26. | percentage of participants | NUMBER |
| SECONDARY | Time to Symptomatic Progression | Randomization until symptomatic progression up to 48.3 months | All randomized participants with a baseline LCS \>= 2 were included. Censored participants: 237 in Cetuximab plus Pemetrexed arm; 244 in Pemetrexed arm; 126 in Cetuximab plus Docetaxel arm; 131 in Docetaxel arm. | months | MEDIAN |
| SECONDARY | Duration of Overall Response (OR) | Time of first occurrence of either (PR) or (CR) to the first date of progressive disease or death up to 32.5 months | All randomized participants with a best overall response of CR or PR. Censored participants: 1 in Cetuximab plus Pemetrexed arm; 2 in Pemetrexed arm; 1 in Cetuximab plus Docetaxel arm; 0 in Docetaxel arm. | months | MEDIAN |
| SECONDARY | Number of Participants With Common Toxicity Criteria (CTC) Grade 3 or 4 Toxicities | Time from first dose to 30 days after last dose of study therapy up to 28.3 months for Cetuximab & Pemetrexed (versus Pemetrexed alone) and up to 54.3 months for Cetuximab + Docetaxel (versus Docetaxel alone) | All randomized participants receiving at least 1 dose of study drug made up the safety population for this outcome measure. Investigators graded events using CTCAE v3.0. Mapping of investigator verbatim terms for toxicity to CTCAE terms was done by the sponsor/designee using CTCAE v4.0. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) | Cetuximab & Pemetrexed | 2.89 | 95% Confidence Interval 2.69 to 3.22 | months | |
| Progression Free Survival (PFS) | Pemetrexed | 2.76 | 95% Confidence Interval 2.53 to 3.29 | months | |
| Progression Free Survival (PFS) | Cetuximab & Docetaxel | 2.37 | 95% Confidence Interval 1.61 to 2.89 | months | |
| Progression Free Survival (PFS) | Docetaxel | 1.54 | 95% Confidence Interval 1.45 to 2.50 | months | |
| Overall Survival (OS) | Cetuximab & Pemetrexed | 6.93 | 95% Confidence Interval 6.28 to 7.85 | months | |
| Overall Survival (OS) | Pemetrexed | 7.79 | 95% Confidence Interval 6.77 to 8.41 | months | |
| Overall Survival (OS) | Cetuximab & Docetaxel | 5.75 | 95% Confidence Interval 4.73 to 8.31 | months | |
| Overall Survival (OS) | Docetaxel | 8.15 | 95% Confidence Interval 6.11 to 9.20 | months | |
| Proportion of Randomized Participants With the Best Overall Response (OR) of Partial Response (PR) or Complete Response (CR) (Overall Response Rate [ORR]) | Cetuximab & Pemetrexed | 0.066 | 95% Confidence Interval 0.038 to 0.095 | proportion of participants | |
| Proportion of Randomized Participants With the Best Overall Response (OR) of Partial Response (PR) or Complete Response (CR) (Overall Response Rate [ORR]) | Pemetrexed | 0.043 | 95% Confidence Interval 0.020 to 0.066 | proportion of participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cetuximab & Pemetrexed | 302 | |
| Overall Study | STARTED | Pemetrexed | 304 | |
| Overall Study | STARTED | Cetuximab and Docetaxel | 167 | |
| Overall Study | STARTED | Docetaxel | 166 | |
| Overall Study | COMPLETED | Cetuximab & Pemetrexed | 6 | |
| Overall Study | COMPLETED | Pemetrexed | 62 | |
| Overall Study | COMPLETED | Cetuximab and Docetaxel | 7 | |
| Overall Study | COMPLETED | Docetaxel | 23 | |
| Overall Study | NOT COMPLETED | Cetuximab & Pemetrexed | 296 | |
| Overall Study | NOT COMPLETED | Pemetrexed | 242 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,160
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 | Cetuximab & Pemetrexed | 70 | 292 | 90 |
| other | Anaemia | Blood and lymphatic system disorders | Pemetrexed | 64 | 289 | 93 |
| other | Anaemia | Blood and lymphatic system disorders | Cetuximab and Docetaxel | 40 | 159 | 75 |
| other | Anaemia | Blood and lymphatic system disorders | Docetaxel | 35 | 149 | 48 |
| other | Leukopenia | Blood and lymphatic system disorders | Cetuximab & Pemetrexed | 10 | 292 | 14 |
| other | Leukopenia | Blood and lymphatic system disorders | Pemetrexed | 11 | 289 | 17 |
| other | Leukopenia | Blood and lymphatic system disorders | Cetuximab and Docetaxel | 15 | 159 | 31 |
| other | Leukopenia | Blood and lymphatic system disorders | Docetaxel | 7 | 149 | 13 |
| other | Neutropenia | Blood and lymphatic system disorders | Cetuximab & Pemetrexed | 32 | 292 | 51 |
| other | Neutropenia | Blood and lymphatic system disorders | Pemetrexed | 32 | 289 | 58 |
1 to 10 of 1,160Source ClinicalTrials.gov
See all 1,160 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cetuximab & Pemetrexed | ||
| Total, all-cause mortality | Pemetrexed | ||
| Total, all-cause mortality | Cetuximab and Docetaxel | ||
| Total, all-cause mortality | Docetaxel | ||
| Total, other adverse events | Cetuximab & Pemetrexed | 289 | 292 |
| Total, other adverse events | Pemetrexed | 281 | 289 |
| Total, other adverse events | Cetuximab and Docetaxel | 159 | 159 |
| Total, other adverse events | Docetaxel | 147 | 149 |
| Total, serious adverse events | Cetuximab & Pemetrexed | 119 | 292 |
| Total, serious adverse events | Pemetrexed | 86 | 289 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24231627 | 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 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
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