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)

NCT ID: NCT02041533

Last Updated: 2023-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 541 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-27
• Study Completion Date: 2022-05-27

Brief 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

Conditions

Stage IV or Recurrent Non-Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A: Nivolumab subjects

Nivolumab solution for Injection 3 mg/kg Intravenous every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure

Group Type: EXPERIMENTAL

Nivolumab

Intervention Type: BIOLOGICAL

Arm B: Investigator's Choice Chemotherapy

Investigator'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

Group Type: ACTIVE_COMPARATOR

Nivolumab

Intervention Type: BIOLOGICAL

Gemcitabine

Intervention Type: DRUG

Cisplatin

Intervention Type: DRUG

Carboplatin

Intervention Type: DRUG

Paclitaxel

Intervention Type: DRUG

Pemetrexed

Intervention Type: DRUG

Interventions

Nivolumab

Intervention Type: BIOLOGICAL

Gemcitabine

Intervention Type: DRUG

Cisplatin

Intervention Type: DRUG

Carboplatin

Intervention Type: DRUG

Paclitaxel

Intervention Type: DRUG

Pemetrexed

Intervention Type: DRUG

Other Intervention Names

BMS-936558; MDX-1106; Gemzar; Platinol; Paraplatin; Taxol; Alimta

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Southern Cancer Center, Inc.

Mobile, Alabama, United States

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Local Institution - 0034

Tucson, Arizona, United States

Local Institution - 0016

Stanford, California, United States

University Of Colorado Hosp

Aurora, Colorado, United States

Local Institution - 0020

New Haven, Connecticut, United States

Local Institution - 0030

Miami, Florida, United States

Local Institution - 0033

Ocala, Florida, United States

H. Lee Moffitt Cancer Center

Tampa, Florida, United States

Local Institution - 0010

Atlanta, Georgia, United States

Northwest Georgia Oncology Center, P.C.

Marietta, Georgia, United States

Local Institution - 0037

Chicago, Illinois, United States

Local Institution - 0014

Lexington, Kentucky, United States

Crescent City Research Consortium, LLC

Marrero, Louisiana, United States

Local Institution - 0024

Baltimore, Maryland, United States

Local Institution - 0036

Boston, Massachusetts, United States

Local Institution - 0070

Boston, Massachusetts, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Local Institution - 0009

New York, New York, United States

Local Institution - 0005

New York, New York, United States

University Of North Carolina At Chapel Hill

Chapel Hill, North Carolina, United States

Local Institution - 0003

Durham, North Carolina, United States

Local Institution - 0012

Cleveland, Ohio, United States

Local Institution - 0027

Columbus, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

Local Institution - 0007

Allentown, Pennsylvania, United States

Local Institution - 0054

Philadelphia, Pennsylvania, United States

Local Institution - 0002

Philadelphia, Pennsylvania, United States

Local Institution - 0018

Pittsburgh, Pennsylvania, United States

Local Institution - 0011

Charleston, South Carolina, United States

Local Institution - 0038

Greenville, South Carolina, United States

Local Institution - 0008

Nashville, Tennessee, United States

Local Institution - 0006

Dallas, Texas, United States

Local Institution - 0023

Houston, Texas, United States

Cancer Centers of South Texas

San Antonio, Texas, United States

Local Institution - 0029

Yakima, Washington, United States

Local Institution - 0051

Berazategui, Buenos Aires, Argentina

Local Institution - 0049

Capital Federal, Buenos Aires, Argentina

Local Institution - 0052

Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

Local Institution - 0048

Córdoba, , Argentina

Local Institution - 0050

Córdoba, , Argentina

Local Institution - 0090

Camperdown, New South Wales, Australia

Local Institution - 0091

Brisbane, Queensland, Australia

Local Institution - 0071

Elizabeth Vale, South Australia, Australia

Local Institution - 0072

Fitzroy, Victoria, Australia

Local Institution - 0104

Heidelberg, Victoria, Australia

Local Institution - 0087

Vienna, , Austria

Local Institution - 0088

Wels, , Austria

Local Institution - 0044

Brussels, , Belgium

Local Institution - 0055

Edegem, , Belgium

Local Institution - 0056

Ghent, , Belgium

Local Institution - 0062

Leuven, , Belgium

Local Institution - 0134

Ijuí, Rio Grande do Sul, Brazil

Local Institution - 0133

Porto Alegre, Rio Grande do Sul, Brazil

Local Institution - 0135

Barretos, São Paulo, Brazil

Local Institution - 0086

Calgary, Alberta, Canada

Local Institution - 0115

Hamilton, Ontario, Canada

Local Institution - 0113

Toronto, Ontario, Canada

Local Institution - 0110

Montreal, Quebec, Canada

Local Institution - 0109

Rimouski, Quebec, Canada

Local Institution - 0059

Olomouc, , Czechia

Local Institution - 0061

Ostrava - Poruba, , Czechia

Local Institution - 0058

Prague, , Czechia

Local Institution - 0060

Ústí nad Labem, , Czechia

Local Institution - 0120

Helsinki, , Finland

Local Institution - 0119

Tampere, , Finland

Local Institution - 0118

Vaasa, , Finland

Local Institution - 0123

Caen, , France

Local Institution - 0105

Lille, , France

Local Institution - 0102

Marseille, , France

Local Institution - 0167

Pontoise, , France

Local Institution - 0100

Rennes, , France

Local Institution - 0140

Strasbourg, , France

Local Institution - 0074

Bamberg, , Germany

Local Institution - 0063

Cologne, , Germany

Local Institution - 0065

Großhansdorf, , Germany

Local Institution - 0064

Heidelberg, , Germany

Local Institution - 0066

Stuttgart, , Germany

Local Institution - 0092

Wiesbaden, , Germany

Local Institution - 0073

Heraklion, Crete, Greece

Local Institution - 0075

Athens, , Greece

Local Institution - 0126

Budapest, , Hungary

Local Institution - 0116

Debrecen, , Hungary

Local Institution - 0094

Mátraháza, , Hungary

Local Institution - 0084

Avellino, , Italy

Local Institution - 0079

Livorno, , Italy

Local Institution - 0143

Milan, , Italy

Local Institution - 0142

Napoli, , Italy

Local Institution - 0083

Perugia, , Italy

Local Institution - 0082

Terni, , Italy

Local Institution - 0146

Nagoya, Aichi-ken, Japan

Local Institution - 0161

Nagoya, Aichi-ken, Japan

Local Institution - 0148

Matsuyama, Ehime, Japan

Local Institution - 0153

Kobe, Hyōgo, Japan

Local Institution - 0144

Natori-shi, Miyagi, Japan

Local Institution - 0151

Niigata, Niigata, Japan

Local Institution - 0166

Habikino-shi, Osaka, Japan

Local Institution - 0147

Miyakojima-ku, Osaka, Japan

Local Institution - 0145

Ōsaka-sayama, Osaka, Japan

Local Institution - 0152

Sakai, Osaka, Japan

Local Institution - 0150

Kitaadachi-gun, Saitama, Japan

Local Institution - 0149

Sunto-gun, Shizuoka, Japan

Local Institution - 0154

Chuo-ku, Tokyo, Japan

Local Institution - 0159

Akashi, Hyogo, , Japan

Local Institution - 0162

Ota, Gunma, , Japan

Local Institution - 0165

Sapporo, Hokkaido, , Japan

Local Institution - 0160

Tokyo, , Japan

Local Institution - 0158

Wakayama, , Japan

Local Institution - 0122

Guadalajara, Jalisco, Mexico

Local Institution - 0117

Mexico City, Mexico City, Mexico

Local Institution - 0124

Mérida, Yucatán, Mexico

Local Institution - 0045

Amsterdam, , Netherlands

Local Institution - 0057

Groningen, , Netherlands

Local Institution - 0046

Rotterdam, , Netherlands

Local Institution - 0114

Bydgoszcz, , Poland

Local Institution - 0131

Krakow, , Poland

Local Institution - 0139

Lodz, , Poland

Local Institution - 0089

Warsaw, , Poland

Local Institution - 0093

Wodzisław Śląski, , Poland

Local Institution - 0068

Cluj-Napoca, , Romania

Local Institution - 0067

Cluj-Napoca, , Romania

Local Institution - 0069

Ploieşti, , Romania

Local Institution - 0155

Gangnam-gu, , South Korea

Local Institution - 0164

Seoul, , South Korea

Local Institution - 0163

Seoul, , South Korea

Local Institution - 0040

Barcelona, , Spain

Local Institution - 0041

Las Palmas de Gran Canaria, , Spain

Local Institution - 0047

Madrid, , Spain

Local Institution - 0042

Málaga, , Spain

Local Institution - 0039

Seville, , Spain

Local Institution - 0043

Valencia, , Spain

Local Institution - 0127

Stockholm, , Sweden

Local Institution - 0125

Uppsala, , Sweden

Local Institution - 0076

Chur, , Switzerland

Local Institution - 0077

Lausanne, , Switzerland

Local Institution - 0078

Zurich, , Switzerland

Local Institution - 0157

Taipei, , Taiwan

Local Institution - 0130

Kayseri, , Turkey (Türkiye)

Local Institution - 0098

London, Greater London, United Kingdom

Local Institution - 0097

Manchester, Greater Manchester, United Kingdom

Local Institution - 0053

Leeds, Yorkshire, United Kingdom

Countries

United States; Argentina; Australia; Austria; Belgium; Brazil; Canada; Czechia; Finland; France; Germany; Greece; Hungary; Italy; Japan; Mexico; Netherlands; Poland; Romania; South Korea; Spain; Sweden; Switzerland; Taiwan; Turkey (Türkiye); United Kingdom

References

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.

Reference Type: DERIVED

PMID: 38383458 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28636851 (View on PubMed)

Related Links

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsstudyconnect.com/s/US/English/USenHome

BMS Clinical Trial Patient Recruiting

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Investigator Inquiry Form

Other Identifiers

2012-004502-93

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA209-026

Identifier Type: -

Identifier Source: org_study_id