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Study of Erlotinib With or Without Investigational Drug (CS-7017) in Subjects With Advanced Non-small Cell Lung Cancer

NCT01101334 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2020-06-16

Study results available
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Summary

This is a Phase 2 and open-label (subject will know the treatment he or she is receiving) study. The subject will receive either Erlotinib alone or Erlotinib + CS-7017 in this study.

The study will determine what effect adding CS-7017 to Erlotinib has on safety and length of survival in subjects with advanced non-small cell lung cancer who failed the first treatment.

Conditions

  • Advanced Non-small Cell Lung Cancer (NSCLC)

Interventions

DRUG

CS-7017

CS-7017, Two 0.25mg Tablets administered twice daily

DRUG

erlotinib

Erlotinib; One 150mg tablet administered once daily

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Leader · Daiichi Sankyo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United States
  • Germany
  • India
  • South Korea

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01101334 on ClinicalTrials.gov