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A Study of Pemetrexed and Carboplatin/Cisplatin or Gemcitabine and Carboplatin/Cisplatin With or Without IMC-1121B in Participants Previously Untreated With Recurrent or Advanced Non-Small Cell Lung Cancer (NSCLC)

NCT01160744 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2019-09-13

Study results available
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Summary

The purpose of this study is to determine if participants with Stage IV NSCLC have a better outcome when treated with IMC-1121B in combination with pemetrexed + carboplatin/cisplatin or gemcitabine + carboplatin/cisplatin than when treated with pemetrexed + carboplatin/cisplatin or gemcitabine + carboplatin/cisplatin alone.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

BIOLOGICAL

IMC-1121B (ramucirumab)

10 milligrams/kilogram (mg/kg) once every 3 weeks beginning Day 1, Cycle 1

DRUG

Pemetrexed

500 milligrams/square meter (mg/m²) on Day 1 of every 21-day cycle

DRUG

Carboplatin (AUC 6)

Day 1 of every 21-day cycle

DRUG

Cisplatin

75 mg/m² intravenous (IV) on Day 1 of each 21-day cycle

DRUG

Gemcitabine

1000 mg/m² on Days 1 and 8 of every 21-day cycle

DRUG

Carboplatin (AUC 5)

Day 1 of every 21-day cycle

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2014-01-31
Completion
2018-04-30

Countries

  • United States
  • Belgium
  • Canada
  • Germany
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT01160744 on ClinicalTrials.gov