NCT01211483

Study of Erlotinib With or Without Investigational Drug (U3-1287) in Subjects With Advanced Non-small Cell Lung Cancer

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• NSCLC (Advanced Non-small Cell Lung Cancer)

Interventions

Type	Name	Description
DRUG	U3-1287	Liquid 70 mg/mL for IV infusion at high dose or low dose
DRUG	Erlotinib	Tablet 150 mg for oral administration
DRUG	Placebo	Placebo liquid matching U3-1287 for IV infusion

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-10-01
• Completion: 2013-11-23
• First posted: 2010-09-29
• Last updated: 2021-06-16
• Results posted: 2021-06-16

Locations

52 sites across 13 countries: United States, Austria, Belgium, Bulgaria, Germany, Hungary, Israel, Italy, Lithuania, Romania, Slovenia, Ukraine, United Kingdom