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Non-Small Cell Lung CancerPhase 2Checkmate 171NCT02409368

An Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) Monotherapy in Subjects With Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC

A Phase 2 study testing Nivolumab in people with Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb at 90 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of the study is to determine the occurrence of high-grade (CTCAE v4.0 Grades 3-4), treatment-related, select adverse events in patients with advanced or metastatic Squamous Cell Non-Small Cell Lung Cancer (SqNSCLC) with progression of disease during or after at least 1 systemic therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
812 participants
Where
90 sitesin 13 countries
Study dates
29 Apr 2015to 27 Aug 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ECOG Status: PS 0-1 \& PS 2
  • Subjects with histologically or cytologically-documented SqNSCLC
  • Subjects must have experienced disease progression or recurrence during or after one prior platinum doublet-based chemotherapy regimen
  • Subjects must have evaluable disease by CT or MRI per RECIST 1.1 criteria
  • Subjects with treated or asymptomatic CNS metastases
  • Prior palliative radiotherapy must have been completed at least 14 days prior to study drug administration
  • Prior lines of antineoplastic therapy, including hemotherapy, hormonal therapy, immunotherapy, surgical resection of lesions, non-palliative radiation therapy, or standard or investigational agents for treatment of NSCLC, must be completed 28 days prior to the first dose of nivolumab
  • Males and Females, ages 18 or older

Who cannot join

  • Subjects with untreated, symptomatic CNS metastases
  • Subjects with carcinomatous meningitis
  • Subjects with active, known or suspected autoimmune disease.
  • Subjects who received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways) or who have previously taken part in a randomized BMS clinical trial for nivolumab or ipilimumab.

Trial locations and contacts

90 sites in 13 countries.

90 sites in 13 countries

United Kingdom22 sites

  • Local Institution - 0345

    Aberdeen, Aberdeen CITY, AB25 2ZN

  • Local Institution - 0171

    Bebington, CH63 4JY

  • Local Institution - 0340

    Bodelwyddan, Rhyl, LL18 5UJ

  • Local Institution - 0344

    Bradford, BD9 6RJ

  • Local Institution - 0190

    Bristol, BS2 8ED

  • Local Institution - 0133

    Cardiff, CF14 2TL

  • Local Institution - 0126

    Cottingham, HU16 5JQ

  • Local Institution - 0195

    Glasgow, Lanarkshire, G12 0YN

  • Local Institution - 0167

    Leicester, Leicestershire, LE1 5WW

  • Local Institution - 0127

    London, Greater London, N18 1QX

  • Local Institution - 0165

    London, W1T 7HA

  • Local Institution - 0169

    London, W6 8RF

  • Local Institution - 0128

    Maidstone, Kent, ME16 9QQ

  • Local Institution - 0191

    Manchester, Greater Manchester, M20 4BX

  • Local Institution - 0194

    Northwood, HA6 2RN

  • Local Institution - 0166

    Plymouth, PL6 8DH

  • Local Institution - 0132

    Preston, Lancashire, PR2 9HT

  • Local Institution - 0124

    Sheffield, S10 5SJ

  • Local Institution - 0131

    Southampton, Hampshire, SO16 6YD

  • Local Institution - 0196

    Sutton, Surrey, SM2 5PT

  • Local Institution - 0189

    Sutton, SM2 5PT

  • Local Institution - 0338

    West Midlands, CV2 2DX

Other trials in United Kingdom

Spain21 sites

  • Local Institution - 0104

    A Coruña, 15006

  • Local Institution - 0119

    Alicante, 03010

  • Local Institution - 0162

    Barcelona, 08036

  • Local Institution - 0112

    Barcelona, 08916

  • Local Institution - 0111

    Barcelona, 8028

  • Local Institution - 0110

    Barcelona, 8035

  • Local Institution - 0108

    Burgos, 09006

  • Local Institution - 0103

    Granada, 18014

  • Local Institution - 0114

    Madrid, 28034

  • Local Institution - 0117

    Madrid, 28040

  • Local Institution - 0116

    Madrid, 28041

  • Local Institution - 0105

    Madrid, 28046

  • Local Institution - 0106

    Málaga, 29010

  • Local Institution - 0337

    Oviedo, Principality of Asturias, 33006

  • Local Institution - 0113

    Palma de Mallorca, 07198

  • Local Institution - 0107

    San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320

  • Local Institution - 0109

    Santander, Cantabria, 39008

  • Local Institution - 0118

    Seville, 41013

  • Local Institution - 0161

    Valencia, 46010

  • Local Institution - 0102

    Valencia, 46026

  • Local Institution - 0163

    Zaragoza, 50009

Other trials in Spain

Poland6 sites

  • Local Institution - 0086

    Gdansk, 80-214

  • Local Institution - 0158

    Gliwice, Silesian Voivodeship, 44-100

  • Local Institution - 0088

    Lodz, 90-302

  • Local Institution - 0087

    Poznan, Greater Poland Voivodeship, 60-693

  • Local Institution - 0089

    Warsaw, 04-141

  • Local Institution - 0184

    Zabrze, Silesian Voivodeship, 41-803

Other trials in Poland

Portugal6 sites

  • Local Institution - 0094

    Coimbra, 3000-602

  • Local Institution - 0093

    Lisbon, 1099-023

  • Local Institution - 0090

    Lisbon, 1769-001

  • Local Institution - 0092

    Porto, 4099-001

  • Local Institution - 0091

    Porto, 4200-072

  • Local Institution - 0159

    Porto, 4200-319

Other trials in Portugal

Romania6 sites

  • Local Institution - 0095

    Bucharest, 022328

  • Local Institution - 0096

    Bucharest, 030171

  • Local Institution - 0098

    Cluj-Napoca, Cluj, 400058

  • Local Institution - 0097

    Cluj-Napoca, 400015

  • Local Institution - 0192

    Oradea, Bihor County, 410469

  • Local Institution - 0187

    Timișoara, Timiș County, 300167

Other trials in Romania

Sweden6 sites

  • Local Institution - 0193

    Gothenburg, Västra Götaland County, 41345

  • Local Institution - 0348

    Linköping, 581 85

  • Local Institution - 0342

    Lund, 22185

  • Local Institution - 0339

    Örebro, Örebro County, SE-70185

  • Local Institution - 0346

    Stockholm, Stockholm County, 17176

  • Local Institution - 0120

    Stockholm, 171 76

Other trials in Sweden

Greece5 sites

  • Local Institution - 0051

    Athens, 11527

  • Local Institution - 0052

    Heraklion, 71110

  • Local Institution - 0177

    Nea Kifisia Athens, 14564

  • Local Institution - 0148

    Pátrai, 26504

  • Local Institution - 0147

    Thessaloniki, 57010

Other trials in Greece

Hungary4 sites

  • Local Institution - 0053

    Budapest, 1121

  • Local Institution - 0347

    Budapest, 1125

  • Local Institution - 0178

    Debrecen, 4032

  • Local Institution - 0054

    Pécs, Baranya, 7624

Other trials in Hungary

Austria3 sites

  • Local Institution - 0003

    Salzburg, 5020

  • Local Institution - 0005

    Vienna, 1140

  • Local Institution - 0002

    Wels, Upper Austria, 4600

Other trials in Austria

Denmark3 sites

  • Local Institution - 0021

    Aalborg, 9000

  • Local Institution - 0020

    Herlev, 2730

  • Local Institution - 0173

    Odense, Region Syddanmark, 5000

Other trials in Denmark

Ireland3 sites

  • Local Institution - 0056

    Dublin, 0

  • Local Institution - 0058

    Galway, ST4 6QG

  • Local Institution - 0349

    Tullamore, Offaly, 0

Other trials in Ireland

Russia3 sites

  • Local Institution - 0160

    Moscow, Moscow, 115478

  • Local Institution - 0100

    Saint Petersburg, Leningradskaya Oblast', 197758

  • Local Institution - 0099

    Saint Petersburg, Sankt-Peterburg, 198255

Other trials in Russia

Finland2 sites

  • Local Institution - 0022

    Oulu, North Ostrobothnia, 90230

  • Local Institution - 0023

    Pori, FI-28500

Other trials in Finland

About this study

The purpose of the study is to determine the occurrence of high-grade (CTCAE v4.0 Grades 3-4), treatment-related, select adverse events in patients with advanced or metastatic Squamous Cell Non-Small Cell Lung Cancer (SqNSCLC) with progression of disease during or after at least 1 systemic therapy.

Being tested
Nivolumab
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02409368
Study groupRoleWhat they receive
Cohort A: Treatment - NivolumabExperimentalNivolumab IV infusion
Receives: Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events

    The total number of participants with high grade treatment related select adverse events.

    Measured: From first dose to time of analysis of primary endpoint (approximately up to 34 months)

Secondary outcomes (5)

  1. Number of Participants With High Grade Select Adverse Events

    The total number of participants with high grade select adverse events. High grade is defined as Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Grades 3-4. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.

    Measured: From first dose up to 100 days post last dose (up to 76 months)

  2. Median Time to Onset of Any Grade Select Adverse Events

    Median Time to onset of any grade select adverse events reported up to 100 days after last dose. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.

    Measured: From first dose up to 100 days post last dose (up to approximately 65 months)

  3. Median Time to Resolution of Any Grade Select Adverse Events

    Median time to resolution of any grade select adverse events reported up to 100 days after last dose. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.

    Measured: From first dose to up to 100 days post last dose (up to approximately 45 months)

  4. Overall Survival

    Overall Survival (OS) is defined as the time from first dosing date to the date of death. A subject who has not died will be censored at last known date alive. OS will be followed continuously while subjects are on treatment and every 3 months via in-person or phone contact after subjects discontinue the study drug.

    Measured: From the first dosing up to the date of death (up to approximately 76 months)

  5. Objective Response Rate (ORR)

    ORR is defined as the percentage of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR). CR is defined as the disappearance of all target lesions; PR is defined by at least a 30% decrease in the sum of the longest diameter of target lesions. ORR as assessed by the investigator will be reported.

    Measured: From first dose up to last dose (up to approximately 76 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2015 (estimated)
  2. Study start29 Apr 2015
  3. Primary completion7 Mar 2018
  4. Study completion27 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
812 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02409368
Sponsor's protocol ID
CA209-171
Other IDs
2014-001285-10, 2014
Acronym
Checkmate 171
Status last verified
Oct 2022
First submitted
1 Apr 2015
Last updated
14 Nov 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Felip E, Ardizzoni A, Ciuleanu T, Cobo M, Laktionov K, Szilasi M, Califano R, Carcereny E, Griffiths R, Paz-Ares L, Duchnowska R, Garcia MA, Isla D, Jassem J, Appel W, Milanowski J, Van Meerbeeck JP, Wolf J, Li A, Acevedo A, Popat S. CheckMate 171: A phase 2 trial of nivolumab in patients with previously treated advanced squamous non-small cell lung cancer, including ECOG PS 2 and elderly populations. Eur J Cancer. 2020 Mar;127:160-172. doi: 10.1016/j.ejca.2019.11.019. Epub 2020 Feb 3.

    PubMed 32028209

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab in people with Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb at 90 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in United Kingdom, Spain, Poland, Portugal, Romania and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events (time frame: From first dose to time of analysis of primary endpoint (approximately up to 34 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02409368, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.

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