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NCT00981058 · ClinicalTrials.gov registry record · Phase 3
First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,093
- Enrollment target
NCT00981058: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT00981058 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 1,093 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00981058, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,093 participants
- Enrollment target
Study Summary
The research study is testing the investigational drug necitumumab (IMC-11F8) in the treatment of advanced non-small cell lung cancer. The aim of this study is to determine if necitumumab, given together with a standard chemotherapy combination consisting of cisplatin and gemcitabine will be more effective in improving participant disease than the standard chemotherapy combination alone.
Primary Outcome
Overall survival is defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive. OS was estimated by the Kaplan-Meier method.
Interventions
- DRUG Cisplatin
- DRUG Gemcitabine
- BIOLOGICAL Necitumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,093 participants |
| Start Date | 2010-01-07 |
| Est. Completion | 2024-05-30 |
| Phase | Phase 3 |
What the finished NCT00981058 record still lists
NCT00981058 is an interventional study that assigns participants to a tested intervention. Its 1,093 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% higher).
The record links to 0 conditions, and to 3 interventions - of which Cisplatin is the first listed.
NCT00981058 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00981058 about?
NCT00981058 is a clinical study titled "First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin". The research study is testing the investigational drug necitumumab (IMC-11F8) in the treatment of advanced non-small cell lung cancer. The aim of this study is to determine if necitumumab, given together with a standard chemotherapy combination consisting of cisplatin and gemcitabine will be more ef...
What is the current status of trial NCT00981058?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,093 participants. The study started on 2010-01-07. Estimated completion is 2024-05-30.
What interventions are being tested in trial NCT00981058?
The interventions under investigation include: Cisplatin (DRUG), Gemcitabine (DRUG), Necitumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00981058?
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 NCT00981058's enrollment target sits among peer trials
1,093 266th of 2000 higher than 1,735 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
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