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AzTrials

Stage IV or Recurrent Non-Small Cell Lung CancerPhase 3NCT02041533

An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer (CheckMate 026)

A Phase 3 study testing Nivolumab, Gemcitabine and Cisplatin in people with Stage IV or Recurrent Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb at 141 sites in 26 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 this study is to show that Nivolumab will improve progression free survival in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared to chemotherapy Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nivolumab, Gemcitabine and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
541 participants
Where
141 sitesin 26 countries
Study dates
27 Mar 2014to 27 May 2022
Phase
Phase 3
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

  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1
  • Histologically confirmed Stage IV, or Recurrent NSCLC with no prior systemic anticancer therapy
  • Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per response evaluation criteria in solid tumors version (RECIST) 1.1 criteria
  • PD-L1+ on immunohistochemistry testing performed by central lab
  • Men and women, ages ≥ 18 years of age

Who cannot join

  • Known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy
  • Known anaplastic lymphoma kinase (ALK) translocations
  • Untreated central nervous system (CNS) metastases
  • Previous malignancies
  • Active, known or suspected autoimmune disease

Trial locations and contacts

141 sites in 26 countries.

141 sites in 26 countries

United States36 sites

  • Local Institution - 0007

    Allentown, Pennsylvania, 18103

  • Local Institution - 0010

    Atlanta, Georgia, 30322

  • University Of Colorado Hosp

    Aurora, Colorado, 80045

  • Local Institution - 0024

    Baltimore, Maryland, 21287

  • Local Institution - 0036

    Boston, Massachusetts, 02114

  • Local Institution - 0070

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • University Of North Carolina At Chapel Hill

    Chapel Hill, North Carolina, 27599-7305

  • Local Institution - 0011

    Charleston, South Carolina, 29425

  • Local Institution - 0037

    Chicago, Illinois, 60612-3841

  • Local Institution - 0012

    Cleveland, Ohio, 44106

  • Local Institution - 0027

    Columbus, Ohio, 43210

  • Local Institution - 0006

    Dallas, Texas, 75390

  • Local Institution - 0003

    Durham, North Carolina, 27710

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • Local Institution - 0038

    Greenville, South Carolina, 29601

  • Local Institution - 0023

    Houston, Texas, 77030

  • Local Institution - 0014

    Lexington, Kentucky, 40503

  • Northwest Georgia Oncology Center, P.C.

    Marietta, Georgia, 30060

  • Crescent City Research Consortium, LLC

    Marrero, Louisiana, 70072

  • Local Institution - 0030

    Miami, Florida, 33176

  • Southern Cancer Center, Inc.

    Mobile, Alabama, 36608

  • Local Institution - 0008

    Nashville, Tennessee, 37232-6307

  • Local Institution - 0020

    New Haven, Connecticut, 06520

  • Local Institution - 0009

    New York, New York, 10016

  • Local Institution - 0005

    New York, New York, 10065

  • Local Institution - 0033

    Ocala, Florida, 34471

  • Local Institution - 0054

    Philadelphia, Pennsylvania, 19104

  • Local Institution - 0002

    Philadelphia, Pennsylvania, 19111

  • Local Institution - 0018

    Pittsburgh, Pennsylvania, 15232

  • Oregon Health & Science University

    Portland, Oregon, 97239-3098

  • Cancer Centers of South Texas

    San Antonio, Texas, 78212

  • Local Institution - 0016

    Stanford, California, 94305-5826

  • H. Lee Moffitt Cancer Center

    Tampa, Florida, 33612

  • Local Institution - 0034

    Tucson, Arizona, 85704

  • Local Institution - 0029

    Yakima, Washington, 98902

Other trials in United States

Japan18 sites

  • Local Institution - 0159

    Akashi, Hyogo, 673-8558

  • Local Institution - 0154

    Chuo-ku, Tokyo, 1040045

  • Local Institution - 0166

    Habikino-shi, Osaka, 5638588

  • Local Institution - 0150

    Kitaadachi-gun, Saitama, 3620806

  • Local Institution - 0153

    Kobe, Hyōgo, 6500047

  • Local Institution - 0148

    Matsuyama, Ehime, 7910280

  • Local Institution - 0147

    Miyakojima-ku, Osaka, 534-0021

  • Local Institution - 0146

    Nagoya, Aichi-ken, 4600001

  • Local Institution - 0161

    Nagoya, Aichi-ken, 4640021

  • Local Institution - 0144

    Natori-shi, Miyagi, 9811293

  • Local Institution - 0151

    Niigata, Niigata, 951-8566

  • Local Institution - 0145

    Ōsaka-sayama, Osaka, 589-8511

  • Local Institution - 0162

    Ota, Gunma, 3738550

  • Local Institution - 0152

    Sakai, Osaka, 591-8555

  • Local Institution - 0165

    Sapporo, Hokkaido, 062-0931

  • Local Institution - 0149

    Sunto-gun, Shizuoka, 4118777

  • Local Institution - 0160

    Tokyo, 1358550

  • Local Institution - 0158

    Wakayama, 641-8510

Other trials in Japan

France6 sites

  • Local Institution - 0123

    Caen, 14000

  • Local Institution - 0105

    Lille, 59000

  • Local Institution - 0102

    Marseille, 13915

  • Local Institution - 0167

    Pontoise, 95303

  • Local Institution - 0100

    Rennes, 35033

  • Local Institution - 0140

    Strasbourg, 67090

Other trials in France

Germany6 sites

  • Local Institution - 0074

    Bamberg, 96049

  • Local Institution - 0063

    Cologne, 50937

  • Local Institution - 0065

    Großhansdorf, 22927

  • Local Institution - 0064

    Heidelberg, 69126

  • Local Institution - 0066

    Stuttgart, 70376

  • Local Institution - 0092

    Wiesbaden, 65199

Other trials in Germany

Italy6 sites

  • Local Institution - 0084

    Avellino, 83100

  • Local Institution - 0079

    Livorno, 57100

  • Local Institution - 0143

    Milan, 20141

  • Local Institution - 0142

    Naples, 80131

  • Local Institution - 0083

    Perugia, 06132

  • Local Institution - 0082

    Terni, 05100

Other trials in Italy

Spain6 sites

  • Local Institution - 0040

    Barcelona, 08035

  • Local Institution - 0041

    Las Palmas de Gran Canaria, 35016

  • Local Institution - 0047

    Madrid, 28050

  • Local Institution - 0042

    Málaga, 29010

  • Local Institution - 0039

    Seville, 41013

  • Local Institution - 0043

    Valencia, 46014

Other trials in Spain

Argentina5 sites

  • Local Institution - 0051

    Berazategui, Buenos Aires, 1880

  • Local Institution - 0049

    Capital Federal, Buenos Aires, 1426

  • Local Institution - 0052

    Ciudad Autonoma de Buenos Aire, Buenos Aires, 1181

  • Local Institution - 0048

    Córdoba, 5000

  • Local Institution - 0050

    Córdoba, 5000

Other trials in Argentina

Australia5 sites

  • Local Institution - 0091

    Brisbane, Queensland, 4102

  • Local Institution - 0090

    Camperdown, New South Wales, 2050

  • Local Institution - 0071

    Elizabeth Vale, South Australia, 5112

  • Local Institution - 0072

    Fitzroy, Victoria, 3065

  • Local Institution - 0104

    Heidelberg, Victoria, 3084

Other trials in Australia

Canada5 sites

  • Local Institution - 0086

    Calgary, Alberta, T2N 4N2

  • Local Institution - 0115

    Hamilton, Ontario, L8V 5C2

  • Local Institution - 0110

    Montreal, Quebec, H2X 3E4

  • Local Institution - 0109

    Rimouski, Quebec, G5L 5T1

  • Local Institution - 0113

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Poland5 sites

  • Local Institution - 0114

    Bydgoszcz, 85-796

  • Local Institution - 0131

    Krakow, 31-202

  • Local Institution - 0139

    Lodz, 93-513

  • Local Institution - 0089

    Warsaw, 02-781

  • Local Institution - 0093

    Wodzisław Śląski, 44-300

Other trials in Poland

Belgium4 sites

  • Local Institution - 0044

    Brussels, 1090

  • Local Institution - 0055

    Edegem, 2650

  • Local Institution - 0056

    Ghent, 9000

  • Local Institution - 0062

    Leuven, 3000

Other trials in Belgium

Czechia4 sites

  • Local Institution - 0059

    Olomouc, 779 00

  • Local Institution - 0061

    Ostrava - Poruba, 708 52

  • Local Institution - 0058

    Prague, 180 81

  • Local Institution - 0060

    Ústí nad Labem, 401 13

Other trials in Czechia

Brazil3 sites

  • Local Institution - 0135

    Barretos, São Paulo, 14780-070

  • Local Institution - 0134

    Ijuí, Rio Grande do Sul, 98700-000

  • Local Institution - 0133

    Porto Alegre, Rio Grande do Sul, 90610-000

Other trials in Brazil

Finland3 sites

  • Local Institution - 0120

    Helsinki, 00029

  • Local Institution - 0119

    Tampere, 33521

  • Local Institution - 0118

    Vaasa, 65130

Other trials in Finland

Hungary3 sites

  • Local Institution - 0126

    Budapest, 1121

  • Local Institution - 0116

    Debrecen, 4032

  • Local Institution - 0094

    Mátraháza, 3233

Other trials in Hungary

Mexico3 sites

  • Local Institution - 0122

    Guadalajara, Jalisco, 44280

  • Local Institution - 0124

    Mérida, Yucatán, 97133

  • Local Institution - 0117

    Mexico City, Mexico City, 14080

Other trials in Mexico

Netherlands3 sites

  • Local Institution - 0045

    Amsterdam, 1066 CX

  • Local Institution - 0057

    Groningen, 9700RB

  • Local Institution - 0046

    Rotterdam, 3014 GD

Other trials in Netherlands

Romania3 sites

  • Local Institution - 0068

    Cluj-Napoca, 400015

  • Local Institution - 0067

    Cluj-Napoca, 400352

  • Local Institution - 0069

    Ploieşti, 100337

Other trials in Romania

South Korea3 sites

  • Local Institution - 0155

    Gangnam-gu, 06351

  • Local Institution - 0164

    Seoul, 03722

  • Local Institution - 0163

    Seoul, 0

Other trials in South Korea

Switzerland3 sites

  • Local Institution - 0076

    Chur, 7000

  • Local Institution - 0077

    Lausanne, 1011

  • Local Institution - 0078

    Zurich, 8091

Other trials in Switzerland

United Kingdom3 sites

  • Local Institution - 0053

    Leeds, Yorkshire, LS9 7TF

  • Local Institution - 0098

    London, Greater London, N18 1QX

  • Local Institution - 0097

    Manchester, Greater Manchester, M20 4XB

Other trials in United Kingdom

Austria2 sites

  • Local Institution - 0087

    Vienna, 1090

  • Local Institution - 0088

    Wels, 4600

Other trials in Austria

Greece2 sites

  • Local Institution - 0075

    Athens, 11527

  • Local Institution - 0073

    Heraklion, Crete, 71110

Other trials in Greece

Sweden2 sites

  • Local Institution - 0127

    Stockholm, 171 76

  • Local Institution - 0125

    Uppsala, 751 85

Other trials in Sweden

Taiwan1 site

  • Local Institution - 0157

    Taipei, 11217

Other trials in Taiwan

Turkey (Türkiye)1 site

  • Local Institution - 0130

    Kayseri, 38039

Other trials in Turkey (Türkiye)

About this study

Official title: An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer

The purpose of this study is to show that Nivolumab will improve progression free survival in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared to chemotherapy

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 NCT02041533
Study groupRoleWhat they receive
Arm A: Nivolumab subjectsExperimentalNivolumab solution for Injection 3 mg/kg Intravenous every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure
Receives: Biological: Nivolumab
Arm B: Investigator's Choice ChemotherapyActive comparatorInvestigator's Choice Chemotherapy administered in 3-week cycles up to a maximum of 6 cycles of Intravenous injection until disease progression, unacceptable toxicity or completion of the 6 cycles, whichever comes first Squamous subjects: * Gemcitabine 1250 mg/mg(2) administered on Day 1 and Day 8 with Cisplatin 75 mg/m(2) administered on Day 1 of each cycle; or * Gemcitabine 1000 mg/mg(2) administered on Day 1 and Day 8 with Carboplatin (AUC 5) administered on Day 1 of each cycle; or * Paclitaxel 200 mg/m(2) with Carboplatin (AUC 6) administered on Day 1 of each cycle Non-Squamous subjects: * Pemetrexed 500 mg/m(2) with Cisplatin 75 mg/m(2) administered on Day 1 of each cycle * Pemetrexed 500 mg/m(2) Carboplatin (AUC 6) administered on Day 1 of each cycle Optional crossover: * Nivolumab solution for Injection 3 mg/kg Intravenous every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent or study closure
Receives: Biological: Nivolumab; Drug: Gemcitabine; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel; Drug: Pemetrexed

What is being measured

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

  1. Progression-Free Survival in Participants With PD-L1 Expression >= 5%

    Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.

    Measured: From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)

Secondary outcomes (5)

  1. Progression-Free Survival in All Randomized Participants

    Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.

    Measured: From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)

  2. Overall Survival in Participants With PD-L1 Expression >= 5%

    Overall Survival (OS) was defined as the time from randomization to the date of death. A participant who had not died was censored at the last known alive date. OS was censored at the date of randomization for participants who were randomized but had no follow-up.

    Measured: From date of randomization to date of death (up to approximately 89 months)

  3. Overall Survival in All Randomized Participants

    Overall Survival (OS) was defined as the time from randomization to the date of death. A participant who had not died was censored at the last known alive date. OS was censored at the date of randomization for participants who were randomized but had no follow-up.

    Measured: From date of randomization to date of death (up to approximately 89 months)

  4. Objective Response Rate (ORR) in Participants With PD-L1 Expression >= 5%

    ORR was defined as the proportion of randomized participants who achieved a Best Overall Response (BOR) of CR or PR using the RECIST v1.1 criteria per Independent Radiology Review Committee (IRRC) assessment. BOR was defined as the best response designation recorded between the date of randomization and the date of objectively documented progression or start of subsequent anti-cancer therapy, whichever occurred first. For participants without documented progression or subsequent therapy, all available response designations contributed to the BOR assessment. For participants who continued treatment beyond progression, BOR was determined from response designations recorded up to the time of initial progression. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir.

    Measured: From date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to August 2016, approximately 28 months)

  5. Disease-related Symptom Improvement Rate by Week 12

    The Lung Cancer Symptom Score (LCSS) is a validated instrument designed to assess the impact of treatment on disease-related symptoms. It consists of 6 symptom-specific questions related to dyspnea, cough, fatigue, pain, hemoptysis and anorexia plus 3 summary items: symptom distress, interference with activity, and global HRQoL. The degree of impairment was recorded on a 100 mm visual analogue scale with scores from 0 to 100 with zero representing the best score. Disease-related symptom improvement rate by Week 12 is defined as the proportion of all randomized (all PD-L1+) participants who had 10 points or more decrease from baseline in average symptom burden index score at any time between randomization and Week 12.

    Measured: From date of randomization to week 12

Timeline

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

  1. First posted22 Jan 2014 (estimated)
  2. Study start27 Mar 2014
  3. Primary completion1 Jul 2016
  4. Study completion27 May 2022

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
541 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02041533
Sponsor's protocol ID
CA209-026
Other IDs
2012-004502-93
Status last verified
Feb 2023
First submitted
19 Jan 2014
Last updated
2 Mar 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Mason M, Lapuente-Santana O, Halkola AS, Wang W, Mall R, Xiao X, Kaufman J, Fu J, Pfeil J, Banerjee J, Chung V, Chang H, Chasalow SD, Lin HY, Chai R, Yu T, Finotello F, Mirtti T, Mayranpaa MI, Bao J, Verschuren EW, Ahmed EI, Ceccarelli M, Miller LD, Monaco G, Hendrickx WRL, Sherif S, Yang L, Tang M, Gu SS, Zhang W, Zhang Y, Zeng Z, Das Sahu A, Liu Y, Yang W, Bedognetti D, Tang J, Eduati F, Laajala TD, Geese WJ, Guinney J, Szustakowski JD, Vincent BG, Carbone DP. A community challenge to predict clinical outcomes after immune checkpoint blockade in non-small cell lung cancer. J Transl Med. 2024 Feb 21;22(1):190. doi: 10.1186/s12967-023-04705-3.

    PubMed 38383458

  • Carbone DP, Reck M, Paz-Ares L, Creelan B, Horn L, Steins M, Felip E, van den Heuvel MM, Ciuleanu TE, Badin F, Ready N, Hiltermann TJN, Nair S, Juergens R, Peters S, Minenza E, Wrangle JM, Rodriguez-Abreu D, Borghaei H, Blumenschein GR Jr, Villaruz LC, Havel L, Krejci J, Corral Jaime J, Chang H, Geese WJ, Bhagavatheeswaran P, Chen AC, Socinski MA; CheckMate 026 Investigators. First-Line Nivolumab in Stage IV or Recurrent Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Jun 22;376(25):2415-2426. doi: 10.1056/NEJMoa1613493.

    PubMed 28636851

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nivolumab, Gemcitabine and Cisplatin in people with Stage IV or Recurrent Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb at 141 sites in 26 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 5 inclusion and 5 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 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 141 sites in United States, Japan, France, Germany, Italy and 21 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 26 Jul 2017). 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?

Progression-Free Survival in Participants With PD-L1 Expression >= 5% (time frame: From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 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 NCT02041533, which also lists 2 linked publications.

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 2 Mar 2023.

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