Study of Erlotinib With or Without Investigational Drug (U3-1287) in Subjects With Advanced Non-small Cell Lung Cancer
Public ClinicalTrials.gov record NCT01211483. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized, Placebo-controlled, Double-blind Phase 1b/2 Study of U3-1287 (AMG 888) in Combination With Erlotinib in EGFR Treatment Naïve Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Progressed on at Least One Prior Chemotherapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 1b/2 study. In Phase 1b, subjects will know the treatment they are receiving. Subjects will receive Erlotinib + U3-1287. The Phase 1b portion will determine if adding U3-1287 to Erlotinib will be safe in subjects with advanced non-small cell lung cancer who fail prior treatment. In the Phase 2 portion, subjects will be blinded to the treatments they are receiving. Subjects will receive either Erlotinib alone or Erlotinib + U3-1287. The Phase 2 portion will determine if adding U3-1287 to Erlotinib will be safe and improve survival in subjects with advanced non-small cell lung cancer who failed the first treatment.
Study identification
- NCT ID
- NCT01211483
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 222 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2010
- Primary completion
- Sep 30, 2013
- Completion
- Nov 22, 2013
- Last update posted
- Jun 15, 2021
2010 – 2013
United States locations
- U.S. sites
- 14
- U.S. states
- 10
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Glendale | Arizona | — | — |
| TRM - Oncology Research Associates, PLLC, d/b/a Pinnacle Oncology Hematology | Scottsdale | Arizona | 85258 | — |
| Not listed | Anaheim | California | — | — |
| Not listed | Encinitas | California | — | — |
| Not listed | La Verne | California | — | — |
| Not listed | Los Angeles | California | — | — |
| Not listed | Orlando | Florida | — | — |
| Not listed | Atlanta | Georgia | — | — |
| Not listed | Joliet | Illinois | — | — |
| Not listed | Evansville | Indiana | — | — |
| Not listed | Baton Rouge | Louisiana | — | — |
| Not listed | Detroit | Michigan | — | — |
| Not listed | The Bronx | New York | — | — |
| Not listed | York | Pennsylvania | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 38 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01211483, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 15, 2021 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01211483 live on ClinicalTrials.gov.