Open-label, Non-randomized Study of U3-1287 in Combination with Erlotinib in Subjects with Advanced Non-Small Cell Lung Cancer (NSCLC) - Extension

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000104-42-DE

Enrollment

Registered

2013-04-05

Start date

2013-06-14

Completion date

Unknown

Last updated

2015-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment for advanced or metastatic NSCLC in combination with erlotinib in subjects who are epidermal growth factor receptor (EGFR) treatment naïve after failure of at least one prior chemotherapy regimen MedDRA version: 14.1 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10029521 Term: Non-small cell lung cance

Interventions

Product Name: U3-1287 (AMG 888) Product Code: U3-1287 (AMG 888) Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Patritumab CAS Number: 1262787-83-6 Current Sponsor code

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subject remains on study treatment under Protocol U31287-A-U201 at the time of U31287-A-U201 study closure. 2. Subject is willing to participate in the extension treatment protocol and provide signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 9 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Subjects who meet any of the following criteria prior to starting this extension will be disqualified from entering the study: - Progression of disease - Occurrence of unacceptable toxicity

Design outcomes

Primary

Measure	Time frame
Main Objective: To allow continuation of study treatment for subjects who have demonstrated clinical benefit (stable disease or better) at the time of study closure for U31287-A-U201.;Secondary Objective: To document the safety profile of U3-1287 combined with erlotinib in these subjects;Primary end point(s): Safety evaluations include adverse events (AEs), serious adverse events (SAEs), clinical laboratory evaluations, physical examinations, vital signs, electrocardiograms (ECGs), echocardiograms, and human antihuman antibodies (HAHA). ;Timepoint(s) of evaluation of this end point: indeterminate.	—

Measure

Time frame

Main Objective: To allow continuation of study treatment for subjects who have demonstrated clinical benefit (stable disease or better) at the time of study closure for U31287-A-U201.;Secondary Objective: To document the safety profile of U3-1287 combined with erlotinib in these subjects;Primary end point(s): Safety evaluations include adverse events (AEs), serious adverse events (SAEs), clinical laboratory evaluations, physical examinations, vital signs, electrocardiograms (ECGs), echocardiograms, and human antihuman antibodies (HAHA). ;Timepoint(s) of evaluation of this end point: indeterminate.

—

Secondary

Measure	Time frame
Secondary end point(s): Pharmacokinetic analysis of serum U3-1287 concentrations may be conducted for subjects who received U3-1287 to correlate with HAHA results obtained at the End of Treatment (EOT) Visit.;Timepoint(s) of evaluation of this end point: indeterminate	—

Countries

Germany

Contacts

Public ContactClinical Trial Information

Daiichi Sankyo Development Limited

info@dsd-eu.com+44 1753 482800

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026