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Completed Phase 3 Interventional Results available

An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy

ClinicalTrials.gov ID: NCT02538666

Public ClinicalTrials.gov record NCT02538666. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 10:42 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Multicenter, Double-Blind, Phase 3 Study of Nivolumab, Nivolumab in Combination With Ipilimumab, or Placebo as Maintenance Therapy in Subjects With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based First Line Chemotherapy (CheckMate 451: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 451)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

In this study, all patients must have already completed first-line chemotherapy to treat extensive-stage disease small cell lung cancer. The purpose of this study is to show that nivolumab, or nivolumab plus ipilimumab followed by nivolumab by itself, will prolong overall survival when administered as consolidation treatment in patients that are stable or responding after chemotherapy. Patients receiving treatment will be compared with patients taking placebo.

Study identification

NCT ID
NCT02538666
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Bristol-Myers Squibb
Industry
Enrollment
907 participants

Conditions and interventions

Conditions

Interventions

Biological · Other

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 13, 2015 (Actual)
Primary completion
Oct 1, 2018 (Actual)
Completion
Nov 11, 2021 (Actual)
Last update posted
Jan 5, 2023

2015 – 2021

United States locations

U.S. sites
28
U.S. states
20
U.S. cities
26
Facility City State ZIP Site status
Local Institution - 0003 Sacramento California 95816 —
Local Institution - 0202 New Haven Connecticut 06520 —
Local Institution - 0127 Fort Myers Florida 33901 —
Local Institution - 0007 Jacksonville Florida 32256 —
Local Institution - 0128 St. Petersburg Florida 33705 —
Local Institution - 0010 Atlanta Georgia 30322 —
Local Institution - 0013 Indianapolis Indiana 46237 —
Local Institution - 0061 Fairway Kansas 66205 —
Local Institution - 0012 Wichita Kansas 67214 —
Local Institution - 0032 Lexington Kentucky 40503 —
Local Institution - 0051 Baltimore Maryland 21287 —
Local Institution - 0107 Boston Massachusetts 02215 —
Local Institution - 0207 Boston Massachusetts 02215 —
Local Institution - 0015 St Louis Missouri 63110 —
Local Institution - 0008 New York New York 10065 —
Local Institution - 0014 Durham North Carolina 27710 —
Local Institution - 0016 Winston-Salem North Carolina 27103 —
Local Institution - 0215 Fargo North Dakota 58102 —
Local Institution - 0129 Cincinnati Ohio 45242 —
Local Institution - 0009 Columbus Ohio 43210 —
Local Institution - 0001 Portland Oregon 97213 —
Local Institution - 0034 Portland Oregon 97239 —
Local Institution - 0004 Allentown Pennsylvania 18103 —
Local Institution - 0002 Sayre Pennsylvania 18840 —
Local Institution - 0005 Charleston South Carolina 29425 —
Local Institution - 0213 Sioux Falls South Dakota 57104 —
Local Institution - 0011 Salt Lake City Utah 84112 —
Local Institution - 0006 Richmond Virginia 23226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 169 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02538666, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 5, 2023 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02538666 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →