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

Conditions

• Advanced Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CS-7017 — DRUG
  CS-7017, Two 0.25mg Tablets administered twice daily
• erlotinib — DRUG
  Erlotinib; One 150mg tablet administered once daily

Study Details

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.

Key Dates

First listed

Apr 9, 2010

Start date

Mar 31, 2010

Status verified

Jun 2020

Primary completion

Apr 30, 2013

Completion

Apr 30, 2013

Study Design

Enrollment

90 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: CS-7017 plus erlotinib
• Active Comparator: erlotinib

Primary Outcome Measure

Summary of Analysis of Progression-Free Survival Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy [ Time Frame: Baseline to disease progression or death, up to approximately 2.5 years ]

Locations (3)

Find similar trials in Denver, CO