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NCT01160744 · ClinicalTrials.gov registry record · Phase 2
A Study of Pemetrexed and Carboplatin/Cisplatin or Gemcitabine and Carboplatin/Cisplatin With or Without IMC-1121B in Participants Previously Untreated With Recurrent or Advanced Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 280
- Enrollment target
NCT01160744: Completed Phase 2 study, sponsored by Eli Lilly and Company.
NCT01160744 is a Phase 2 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 280 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (111% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01160744, a Phase 2 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 280 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if participants with Stage IV NSCLC have a better outcome when treated with IMC-1121B in combination with pemetrexed + carboplatin/cisplatin or gemcitabine + carboplatin/cisplatin than when treated with pemetrexed + carboplatin/cisplatin or gemcitabine + carboplatin/cisplatin alone.
Primary Outcome
PFS was the time from randomization to the first objective progression as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v 1.1) or death from any cause, whichever occurred first. Progressive disease (PD) was defined as ≥20% increase in sum of diameter (SOD) of target lesions and short axes of target lymph nodes, taking as reference the smallest sum of the longest diameters recorded since treatment started and an absolute increase in sum diameter of ≥5 millimeters (m
Interventions
- DRUG Cisplatin
- DRUG Pemetrexed
- DRUG Gemcitabine
- BIOLOGICAL IMC-1121B (ramucirumab)
- DRUG Carboplatin (AUC 6)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2010-09 |
| Est. Completion | 2018-04 |
| Phase | Phase 2 |
What the finished NCT01160744 record still lists
NCT01160744 is an interventional study that assigns participants to a tested intervention. The registered 280 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (111% higher).
The record links to 0 conditions, and to 5 interventions - of which Cisplatin is the first listed.
NCT01160744 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01160744 about?
NCT01160744 is a clinical study titled "A Study of Pemetrexed and Carboplatin/Cisplatin or Gemcitabine and Carboplatin/Cisplatin With or Without IMC-1121B in Participants Previously Untreated With Recurrent or Advanced Non-Small Cell Lung Cancer (NSCLC)". The purpose of this study is to determine if participants with Stage IV NSCLC have a better outcome when treated with IMC-1121B in combination with pemetrexed + carboplatin/cisplatin or gemcitabine + carboplatin/cisplatin than when treated with pemetrexed + carboplatin/cisplatin or gemcitabine + car...
What is the current status of trial NCT01160744?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 280 participants. The study started on 2010-09. Estimated completion is 2018-04.
What interventions are being tested in trial NCT01160744?
The interventions under investigation include: Cisplatin (DRUG), Pemetrexed (DRUG), Gemcitabine (DRUG), IMC-1121B (ramucirumab) (BIOLOGICAL), Carboplatin (AUC 6) (DRUG).
Who is sponsoring clinical trial NCT01160744?
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 NCT01160744's enrollment target sits among peer trials
280 196th of 2000 higher than 1,800 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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