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NCT01933932 · ClinicalTrials.gov registry record · Phase 3
Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC
A Phase 3 study of Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 3
- Development phase
- 510
- Enrollment target
- 20
- Study locations
NCT01933932: Active Phase 3 study of Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV, sponsored by AstraZeneca.
NCT01933932 is a Phase 3 study of Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 510 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01933932, a Phase 3 study of Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 510 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the efficacy of selumetinib in combination with docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also assess the PK, safety, patient reported outcomes (PRO) and tolerability profile of the selumetinib/docetaxel combination, compared to placebo in combination with docetaxel
Primary Outcome
Progression free survival is defined as the time from randomisation until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Docetaxel
- DRUG Selumetinib
- DRUG Pegylated G-CSF
Study Locations (20)
Massachusetts
- Research Site - Boston
- Research Site - Boston
- Research Site - Danvers
Other
- Research Site - Buenos Aires
- Research Site - Ciudad de Buenos Aires
- Research Site - Ciudad de Buenos Aires
New York
- Research Site - New York
- Research Site - New York
Pennsylvania
- Research Site - Hershey
- Research Site - Philadelphia
Tennessee
- Research Site - Nashville
- Research Site - Nashville
Colorado
- Research Site - Aurora
Florida
- Research Site - Pembroke Pines
Georgia
- Research Site - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 510 participants |
| Start Date | 2013-09-25 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 3 |
What the registry record for NCT01933932 still lists
NCT01933932 is an interventional study that assigns participants to a tested intervention. The registered 510 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 (34% lower).
The record links to 1 condition, with Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT01933932 names 20 study sites across 13 states, led by Massachusetts, Other, New York.
Frequently Asked Questions
What is clinical trial NCT01933932 about?
NCT01933932 is a clinical study titled "Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC". The purpose of this study is to assess the efficacy of selumetinib in combination with docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also assess the PK, safety, patient repor...
What is the current status of trial NCT01933932?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 510 participants. The study started on 2013-09-25. Estimated completion is 2025-12-31.
What conditions does trial NCT01933932 study?
This clinical trial studies the following conditions: Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV.
What interventions are being tested in trial NCT01933932?
The interventions under investigation include: Placebo (DRUG), Docetaxel (DRUG), Selumetinib (DRUG), Pegylated G-CSF (DRUG).
Who is sponsoring clinical trial NCT01933932?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01933932 being conducted?
This trial has 20 study locations across Colorado, Florida, Georgia, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01933932's enrollment target sits among peer trials
510 729th of 2000 higher than 1,265 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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