Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00095199 · ClinicalTrials.gov registry record · Phase 3
Docetaxel or Pemetrexed With or Without Cetuximab in Patients With Recurrent or Progressive Non-Small Cell Lung Cancer
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 939
- Enrollment target
NCT00095199: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT00095199 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 939 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00095199, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 939 participants
- Enrollment target
Study Summary
This trial is a multicenter, open-label, randomized, Phase III study in patients with recurrent or progressive Non-Small Cell Lung Cancer (NSCLC) after failure of an initial platinum-based chemotherapy. Patients will receive either Docetaxel or Pemetrexed as chemotherapy at the investigator's choice. Within each chemotherapy group, patients will be randomized to receive Cetuximab plus chemotherapy or chemotherapy alone (Cetuximab \& Pemetrexed or Pemetrexed alone; Cetuximab \& Docetaxel or Docetaxel alone).
Primary Outcome
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).
Interventions
- DRUG Docetaxel
- DRUG Pemetrexed
- BIOLOGICAL Cetuximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 939 participants |
| Start Date | 2005-01 |
| Est. Completion | 2011-07 |
| Phase | Phase 3 |
What the finished NCT00095199 record still lists
NCT00095199 is an interventional study that assigns participants to a tested intervention. The registered 939 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% higher).
The record links to 0 conditions, and to 3 interventions - of which Docetaxel is the first listed.
NCT00095199 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00095199 about?
NCT00095199 is a clinical study titled "Docetaxel or Pemetrexed With or Without Cetuximab in Patients With Recurrent or Progressive Non-Small Cell Lung Cancer". This trial is a multicenter, open-label, randomized, Phase III study in patients with recurrent or progressive Non-Small Cell Lung Cancer (NSCLC) after failure of an initial platinum-based chemotherapy. Patients will receive either Docetaxel or Pemetrexed as chemotherapy at the investigator's choice...
What is the current status of trial NCT00095199?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 939 participants. The study started on 2005-01. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00095199?
The interventions under investigation include: Docetaxel (DRUG), Pemetrexed (DRUG), Cetuximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00095199?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00095199's enrollment target sits among peer trials
939 338th of 2000 higher than 1,663 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03075696 · 940 participants · Phase 1
A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma
- NCT06855277 · 940 participants · Phase 3
Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC
- NCT06808334 · 942 participants
CLAiR Pivotal Study
- NCT07190209 · 942 participants · Phase 3
Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia