Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)

Conditions

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ipilimumab — DRUG
  Ipilimumab, 10 mg/kg, administered as a single-dose, intravenously (IV), over 90 minutes depending on randomization every 3 weeks (up to 6 doses). Participants could receive additional maintenance ipilimumab at a dose of 10 mg/kg every 12 weeks starting 24 weeks after the first ipilimumab dose.
• Placebo — DRUG
  Matched placebo for ipilimumab administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants could also receive additional maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first placebo dose.
• Paclitaxel — DRUG
  175 mg/m\^2, administered as a single IV dose over 3 hours every 3 weeks (up to 6 doses). Dose modifications (reductions as well as delays) done as per product label.
• Carboplatin — DRUG
  Area under the concentration curve (AUC)=6, administered as a single IV dose over 30 minutes every 3 weeks (up to 6 doses) as per randomization. Dose modifications (reductions as well as delays) done as per product label.

Study Details

The purpose of the study is to determine whether ipilimumab given with paclitaxel/carboplatin has clinical benefit when compared with paclitaxel/carboplatin alone in patients with previously untreated lung cancer.

Key Dates

Start date

Feb 29, 2008

Status verified

Jun 2018

Primary completion

Oct 31, 2009

Completion

Dec 31, 2011

Study Design

Enrollment

334 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ipilimumab/ placebo + paclitaxel + carboplatin (concurrent)
• Experimental: Ipilimumab/ placebo + paclitaxel + carboplatin (sequential)
• Active Comparator: Ipilimumab placebo + paclitaxel + carboplatin

Primary Outcome Measure

Immune-related Progression-free Survival (irPFS) in Participants With Nonsmall-cell Lung Cancer (NSCLC) Per Immune-related Response Criteria (irRC) [ Time Frame: Tumor assessed at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until immune-related Progressive Disease (irPD) or death (of censored, maximum reached: 16.5 months) ]

Locations (27)

Find similar trials in Birmingham, AL

Related Studies

• Evaluation for NCI Surgery Branch Clinical Research Protocols
  Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland
• Collection of Blood From Patients With Cancer
  Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland
• Detection of Genetic Markers of Lung Cancer
  Recruiting · University of Pittsburgh · Pittsburgh, Pennsylvania
• Lung Cancer Biomarkers and Screening
  Recruiting · NYU Langone Health · New York, New York