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NCT01328951 · ClinicalTrials.gov registry record · Phase 3
A Study of First-line Maintenance Erlotinib Versus Erlotinib at Disease Progression in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Platinum-Based Chemotherapy
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 643
- Enrollment target
NCT01328951: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT01328951 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 643 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01328951, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 643 participants
- Enrollment target
Study Summary
This double-blind, placebo-controlled study will evaluate the benefit of first-line maintenance erlotinib (Tarceva) versus erlotinib at the time of disease progression in participants with advanced NSCLC who have not progressed following 4 cycles of platinum based-chemotherapy and whose tumor does not harbor an epidermal growth factor receptor (EGFR)-activating mutation. Participants will be randomized to receive either erlotinib 150 milligrams (mg) orally (PO) once daily or placebo. Participants who progress on placebo will receive erlotinib 150 mg PO once daily as second-line therapy, and those who progress on erlotinib may switch to a non-investigational, second-line chemotherapy. Treatments will continue until disease progression, death, or unacceptable toxicity. Participants may also be entered into a final Survival Follow-Up (SFU) period upon treatment discontinuation.
Primary Outcome
Participants were followed for survival until death or premature withdrawal. The percentage of participants who died during the Overall Study (BP, OLP, or SFU) was calculated.
Interventions
- DRUG Placebo
- DRUG Erlotinib
- DRUG Second-Line Chemotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 643 participants |
| Start Date | 2011-09 |
| Est. Completion | 2016-01 |
| Phase | Phase 3 |
What the finished NCT01328951 record still lists
NCT01328951 is an interventional study that assigns participants to a tested intervention. The registered 643 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01328951 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01328951 about?
NCT01328951 is a clinical study titled "A Study of First-line Maintenance Erlotinib Versus Erlotinib at Disease Progression in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Platinum-Based Chemotherapy". This double-blind, placebo-controlled study will evaluate the benefit of first-line maintenance erlotinib (Tarceva) versus erlotinib at the time of disease progression in participants with advanced NSCLC who have not progressed following 4 cycles of platinum based-chemotherapy and whose tumor does n...
What is the current status of trial NCT01328951?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 643 participants. The study started on 2011-09. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01328951?
The interventions under investigation include: Placebo (DRUG), Erlotinib (DRUG), Second-Line Chemotherapy (DRUG).
Who is sponsoring clinical trial NCT01328951?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01328951's enrollment target sits among peer trials
643 573rd of 2000 higher than 1,427 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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