Phase
Condition
Non-small Cell Lung Cancer
Treatment
Pemetrexed
Paclitaxel
Ipilimumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria
Participants must have histologically confirmed stage IV or recurrent non-small cell lung cancer (NSCLC) (as defined by the 9th edition of the IASLC Lung Cancer Staging Guidelines) of squamous or non-squamous histology.
Participants must have no prior systemic anti-cancer treatment (including EGFR, ALK, ROS-1, BRAF, RET, and NTRK inhibitors) given as primary therapy for advanced or metastatic disease.
Participants with prior definitive chemoradiation for locally advanced disease is permitted as long as the last administration of chemotherapy or radiotherapy (whichever was given last) occurred at least 6 months prior to randomization. Participants with locally advanced disease with recurrence after chemoradiation therapy (stage III disease, specifically refers to patients with no curative options) are eligible to enroll.
Participants with prior adjuvant or neoadjuvant chemotherapy for early-stage lung cancer are permitted if completed at least 6 months prior to randomization.
Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 at screening and confirmed prior to randomization.
Participants must have measurable disease by CT or MRI per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria with radiographic tumor assessment performed within 28 days of randomization.
Exclusion Criteria
Participants must not have any prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
Participants must not have any known driver mutations with available targeted therapy (including but not limited to EGFR mutations, ALK translocations, ROS-1 translocations and known BRAFV600E, that are sensitive to available targeted inhibitor therapy; participants with a known activating RET mutations and NTRK fusion gene alterations).
Participants must not have any untreated central nervous system (CNS) metastases
Participants must not have leptomeningeal metastases (carcinomatous meningitis).
Participants must not have any active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
Participants with previous malignancies (except non-melanoma skin cancers, and in situ cancers such as the following: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to randomization and no additional therapy is required or anticipated to be required during the study period.
Participants must not have a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) within 14 days or other immunosuppressive medications within 30 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
Participants must not have any history of interstitial lung disease or pneumonitis that required oral or IV glucocorticoids to assist with management.
Other protocol-defined Inclusion/Exclusion criteria apply.
Study Design
Connect with a study center
Local Institution - 0041
Brasilia, Distrito Federal 70200-730
BrazilSite Not Available
Hospital Sirio Libanes
Brasília, Federal District 70200-730
BrazilActive - Recruiting
Local Institution - 0041
Brasília, Federal District 70200-730
BrazilSite Not Available
Local Institution - 0041
Brasília 3469058, Federal District 3463504 70200-730
BrazilSite Not Available
Hospital Luxemburgo
Belo Horizonte, Minas Gerais 30380-490
BrazilActive - Recruiting
Local Institution - 0043
Belo Horizonte, Minas Gerais 30380-490
BrazilSite Not Available
Local Institution - 0043
Belo Horizonte 3470127, Minas Gerais 3457153 30380-490
BrazilSite Not Available
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul 90035-903
BrazilActive - Recruiting
Local Institution - 0038
Porto Alegre, Rio Grande do Sul 90035-903
BrazilSite Not Available
Hospital de Clinicas de Porto Alegre
Porto Alegre 3452925, Rio Grande do Sul 3451133 90035-903
BrazilSite Not Available
Local Institution - 0038
Porto Alegre 3452925, Rio Grande do Sul 3451133 90035-903
BrazilSite Not Available
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo 14784400
BrazilActive - Recruiting
Local Institution - 0037
Barretos, São Paulo 14784400
BrazilSite Not Available
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos 3470451, São Paulo 3448433 14784400
BrazilSite Not Available
Local Institution - 0037
Barretos 3470451, São Paulo 3448433 14784400
BrazilSite Not Available
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, 01246-000
BrazilActive - Recruiting
Local Institution - 0034
São Paulo, 01246-000
BrazilSite Not Available
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo 3448439, 01246-000
BrazilSite Not Available
Local Institution - 0034
São Paulo 3448439, 01246-000
BrazilSite Not Available
Local Institution - 0068
Antofagasta, AN 1240000
ChileSite Not Available
Local Institution - 0068
Antofagasta 3899539, AN 1240000
ChileSite Not Available
Local Institution - 0069
Viña del Mar, Región de Valparaíso 2520598
ChileSite Not Available
Local Institution - 0069
Viña del Mar 3868121, Región de Valparaíso 3868621 2520598
ChileSite Not Available
Bradfordhill
Santiago, Santiago Metropolitan 8420383
ChileActive - Recruiting
Local Institution - 0067
Santiago, Santiago Metropolitan 8420383
ChileSite Not Available
Local Institution - 0067
Santiago 3871336, Santiago Metropolitan 3873544 8420383
ChileSite Not Available
Centre Georges François Leclerc
Dijon, Côte-d'Or 21079
FranceActive - Recruiting
Local Institution - 0065
Dijon, Côte-d'Or 21079
FranceSite Not Available
Centre Georges François Leclerc
Dijon 3021372, Côte-d'Or 21079
FranceSite Not Available
Local Institution - 0065
Dijon 3021372, Côte-d'Or 21079
FranceSite Not Available
Hôpital Foch
Suresnes, Hauts-de-Seine 92151
FranceActive - Recruiting
Local Institution - 0003
Suresnes, Hauts-de-Seine 92151
FranceSite Not Available
Hôpital Foch
Suresnes 2973675, Hauts-de-Seine 92151
FranceSite Not Available
Local Institution - 0003
Suresnes 2973675, Hauts-de-Seine 92151
FranceSite Not Available
Groupe hospitalier Paris saint Joseph
Paris, Île-de-France Region 75014
FranceActive - Recruiting
Local Institution - 0010
Paris, Île-de-France Region 75014
FranceSite Not Available
Groupe hospitalier Paris saint Joseph
Paris 2988507, Île-de-France Region 3012874 75014
FranceSite Not Available
Local Institution - 0010
Paris 2988507, Île-de-France Region 3012874 75014
FranceSite Not Available
Local Institution - 0012
Athens, Attikí 115 27
GreeceSite Not Available
Thoracic General Hospital of Athens "I Sotiria"
Athens, Attikí 115 27
GreeceActive - Recruiting
Local Institution - 0012
Athens 264371, Attikí 115 27
GreeceSite Not Available
Thoracic General Hospital of Athens "I Sotiria"
Athens 264371, Attikí 115 27
GreeceSite Not Available
Local Institution - 0013
Chaidari, Attikí 12462
GreeceSite Not Available
Local Institution - 0013
Chaïdári, Attikí 12462
GreeceSite Not Available
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
Chaïdári, Attikí 12462
GreeceActive - Recruiting
Local Institution - 0013
Chaïdári 260183, Attikí 12462
GreeceSite Not Available
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
Chaïdári 260183, Attikí 12462
GreeceSite Not Available
"Theagenio" Cancer Hospital of Thessaloniki
Thessaloniki, Kentrikí Makedonía 540 07
GreeceActive - Recruiting
Local Institution - 0011
Thessaloniki, Kentrikí Makedonía 540 07
GreeceSite Not Available
"Theagenio" Cancer Hospital of Thessaloniki
Thessaloniki 734077, Kentrikí Makedonía 540 07
GreeceSite Not Available
Local Institution - 0011
Thessaloniki 734077, Kentrikí Makedonía 540 07
GreeceSite Not Available
Local Institution - 0014
Larissa, Thessalía 41110
GreeceSite Not Available
University General Hospital of Larissa
Larissa, Thessalía 41110
GreeceActive - Recruiting
Local Institution - 0014
Larissa 258576, Thessalía 41110
GreeceSite Not Available
University General Hospital of Larissa
Larissa 258576, Thessalía 41110
GreeceSite Not Available
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola, Emilia-Romagna 47014
ItalyActive - Recruiting
Local Institution - 0015
Meldola, Emilia-Romagna 47014
ItalySite Not Available
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola 3173635, Emilia-Romagna 3177401 47014
ItalySite Not Available
Local Institution - 0015
Meldola 3173635, Emilia-Romagna 3177401 47014
ItalySite Not Available
Local Institution - 0057
Udine, Friuli Venezia Giulia 33100
ItalySite Not Available
P.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale
Udine, Friuli Venezia Giulia 33100
ItalyActive - Recruiting
Local Institution - 0057
Udine 3165072, Friuli Venezia Giulia 3176525 33100
ItalySite Not Available
P.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale
Udine 3165072, Friuli Venezia Giulia 3176525 33100
ItalySite Not Available
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, Lombardy 24127
ItalyActive - Recruiting
Local Institution - 0020
Bergamo, Lombardy 24127
ItalySite Not Available
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo 3182164, Lombardy 3174618 24127
ItalySite Not Available
Local Institution - 0020
Bergamo 3182164, Lombardy 3174618 24127
ItalySite Not Available
Local Institution - 0019
Firenze, Toscana 50134
ItalySite Not Available
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany 50134
ItalyActive - Recruiting
Local Institution - 0019
Florence, Tuscany 50134
ItalySite Not Available
Azienda Ospedaliera Universitaria Careggi
Florence 3176959, Tuscany 3165361 50134
ItalySite Not Available
Local Institution - 0019
Florence 3176959, Tuscany 3165361 50134
ItalySite Not Available
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, 28100
ItalyActive - Recruiting
Local Institution - 0017
Novara, 28100
ItalySite Not Available
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara 3172189, 28100
ItalySite Not Available
Local Institution - 0017
Novara 3172189, 28100
ItalySite Not Available
Local Institution - 0025
Guadalajara, Jalisco 44630
MexicoSite Not Available
Local Institution - 0025
Guadalajara 4005539, Jalisco 4004156 44630
MexicoSite Not Available
Local Institution - 0058
Monterrey, Nuevo León 64460
MexicoSite Not Available
Local Institution - 0058
Monterrey 3995465, Nuevo León 3522542 64460
MexicoSite Not Available
Local Institution - 0027
Merida, Yucatán 97070
MexicoSite Not Available
Local Institution - 0027
Mérida, Yucatán 97070
MexicoSite Not Available
Local Institution - 0027
Mérida 3523349, Yucatán 3514211 97070
MexicoSite Not Available
Local Institution - 0024
Mexico, 06700
MexicoSite Not Available
Local Institution - 0024
México, 06700
MexicoSite Not Available
Local Institution - 0024
México 10248874, 06700
MexicoSite Not Available
Local Institution - 0022
Puebla, 72424
MexicoSite Not Available
Local Institution - 0022
Puebla City, 72424
MexicoSite Not Available
Local Institution - 0022
Puebla City 3521081, 72424
MexicoSite Not Available
Local Institution - 0081
Warsaw, Masovian Voivodeship 03-411
PolandSite Not Available
Mazowiecki Szpital Onkologiczny
Warsaw, Masovian Voivodeship 03-411
PolandActive - Recruiting
Local Institution - 0081
Warsaw 756135, Masovian Voivodeship 858787 03-411
PolandSite Not Available
Mazowiecki Szpital Onkologiczny
Warsaw 756135, Masovian Voivodeship 858787 03-411
PolandSite Not Available
Local Institution - 0081
Warszawa, Mazowieckie 03-411
PolandSite Not Available
Local Institution - 0080
Prabuty, Pomeranian Voivodeship 82-550
PolandSite Not Available
Szpital Specjalistyczny w Prabutach Spolka z o.o.
Prabuty, Pomeranian Voivodeship 82-550
PolandActive - Recruiting
Local Institution - 0080
Prabuty 3088161, Pomeranian Voivodeship 3337496 82-550
PolandSite Not Available
Szpital Specjalistyczny w Prabutach Spolka z o.o.
Prabuty 3088161, Pomeranian Voivodeship 3337496 82-550
PolandSite Not Available
Local Institution - 0079
Łódź, Łódzkie 93-338
PolandSite Not Available
Instytut Centrum Zdrowia Matki Polki
Lodz, Łódź Voivodeship 93-338
PolandActive - Recruiting
Local Institution - 0079
Lodz, Łódź Voivodeship 93-338
PolandSite Not Available
Instytut Centrum Zdrowia Matki Polki
Lodz 3093133, Łódź Voivodeship 3337493 93-338
PolandSite Not Available
Local Institution - 0079
Lodz 3093133, Łódź Voivodeship 3337493 93-338
PolandSite Not Available
Institutul Oncologic Bucuresti "Prof. Dr. Alexandru Trestioreanu"
Bucharest, Bucharest 022328
RomaniaActive - Recruiting
Local Institution - 0073
Bucharest, Bucharest 022328
RomaniaSite Not Available
Institutul Oncologic Bucuresti
Bucharest 683506, București 683504 022328
RomaniaSite Not Available
Local Institution - 0073
Bucharest 683506, București 683504 022328
RomaniaSite Not Available
Local Institution - 0076
Florești, Cluj 407280
RomaniaSite Not Available
SC Radiotherapy Center Cluj SRL
Florești, Cluj 407280
RomaniaActive - Recruiting
Centrul de Oncologie "Sfântul Nectarie"
Craiova, Dolj 200542
RomaniaActive - Recruiting
Local Institution - 0077
Craiova, Dolj 200542
RomaniaSite Not Available
Centrul de Oncologie "Sfântul Nectarie"
Craiova 680332, Dolj 679134 200542
RomaniaSite Not Available
Local Institution - 0077
Craiova 680332, Dolj 679134 200542
RomaniaSite Not Available
Centrul de Diagnostic si Tratament Provita
Bucharest, 020335
RomaniaActive - Recruiting
Local Institution - 0075
Bucharest, 020335
RomaniaSite Not Available
Centrul de Diagnostic si Tratament Provita
Bucharest 683506, 020335
RomaniaActive - Recruiting
Local Institution - 0075
Bucharest 683506, 020335
RomaniaSite Not Available
Local Institution - 0074
Cluj, 400015
RomaniaSite Not Available
Institutul Oncologic Cluj
Cluj-Napoca, 400015
RomaniaActive - Recruiting
Local Institution - 0074
Cluj-Napoca, 400015
RomaniaSite Not Available
Institutul Oncologic Cluj
Cluj-Napoca 681290, 400015
RomaniaSite Not Available
Local Institution - 0074
Cluj-Napoca 681290, 400015
RomaniaSite Not Available
Institutul Regional de Oncologie
Iași, 700483
RomaniaActive - Recruiting
Local Institution - 0078
Iași, 700483
RomaniaSite Not Available
Institutul Regional de Oncologie
Iași 675810, 700483
RomaniaSite Not Available
Local Institution - 0078
Iași 675810, 700483
RomaniaSite Not Available
Local Institution - 0009
Sandton, GP 2196
South AfricaSite Not Available
Local Institution - 0009
Sandton 957654, GP 2196
South AfricaSite Not Available
Local Institution - 0066
Pretoria, Gauteng 0181
South AfricaSite Not Available
Local Institution - 0031
Soweto, Gauteng 2013
South AfricaSite Not Available
Wits Clinical Research
Soweto, Gauteng 2013
South AfricaActive - Recruiting
Local Institution - 0066
Pretoria 964137, Gauteng 1085594 0181
South AfricaSite Not Available
Local Institution - 0031
Soweto 953781, Gauteng 1085594 2013
South AfricaSite Not Available
Wits Clinical Research
Soweto 953781, Gauteng 1085594 2013
South AfricaSite Not Available
Cancercare Rondebosch Oncology
Rondebosch, Western Cape 7700
South AfricaActive - Recruiting
Local Institution - 0084
Rondebosch, Western Cape 7700
South AfricaSite Not Available
Cancercare Rondebosch Oncology
Rondebosch 7302802, Western Cape 1085599 7700
South AfricaSite Not Available
Local Institution - 0084
Rondebosch 7302802, Western Cape 1085599 7700
South AfricaSite Not Available
Local Institution - 0070
Adana, 01140
TurkeySite Not Available
Local Institution - 0072
Ankara, 06010
TurkeySite Not Available
Local Institution - 0071
Istanbul, 34214
TurkeySite Not Available
Local Institution - 0070
Adana, 01140
Turkey (Türkiye)Site Not Available
Local Institution - 0070
Adana 325363, 01140
Turkey (Türkiye)Site Not Available
Local Institution - 0072
Ankara, 06010
Turkey (Türkiye)Site Not Available
Local Institution - 0072
Ankara 323786, 06010
Turkey (Türkiye)Site Not Available
Local Institution - 0071
Istanbul, 34214
Turkey (Türkiye)Site Not Available
Local Institution - 0071
Istanbul 745044, 34214
Turkey (Türkiye)Site Not Available
Alaska Oncology and Hematology
Anchorage, Alaska 99508
United StatesActive - Recruiting
Local Institution - 0032
Anchorage, Alaska 99508
United StatesSite Not Available
Alaska Oncology and Hematology
Anchorage 5879400, Alaska 5879092 99508
United StatesSite Not Available
Local Institution - 0062
Los Angeles, California 90033
United StatesSite Not Available
USC/Norris Comprehensive Cancer Center
Los Angeles, California 90033
United StatesActive - Recruiting
Local Institution - 0088
Newport Beach, California 92663
United StatesSite Not Available
Local Institution - 0062
Los Angeles 5368361, California 5332921 90033
United StatesSite Not Available
USC/Norris Comprehensive Cancer Center
Los Angeles 5368361, California 5332921 90033
United StatesSite Not Available
Local Institution - 0088
Newport Beach 5376890, California 5332921 92663
United StatesSite Not Available
Local Institution - 0052
Boise, Idaho 83706
United StatesSite Not Available
Local Institution - 0063
Boise, Idaho 83702
United StatesSite Not Available
Saint Alphonsus Regional Medical Center
Boise, Idaho 83706
United StatesActive - Recruiting
Beacon Cancer Care
Post Falls, Idaho 83854
United StatesActive - Recruiting
Local Institution - 0064
Post Falls, Idaho 83854
United StatesSite Not Available
Local Institution - 0052
Boise 5586437, Idaho 5596512 83706
United StatesSite Not Available
Local Institution - 0063
Boise 5586437, Idaho 5596512 83702
United StatesSite Not Available
Saint Alphonsus Regional Medical Center
Boise 5586437, Idaho 5596512 83706
United StatesSite Not Available
Beacon Cancer Care
Post Falls 5604353, Idaho 5596512 83854
United StatesSite Not Available
Local Institution - 0064
Post Falls 5604353, Idaho 5596512 83854
United StatesSite Not Available
Local Institution - 0033
Cleveland, Ohio 44109
United StatesSite Not Available
Local Institution - 0047
Cleveland, Ohio 44106
United StatesSite Not Available
MetroHealth Medical Center
Cleveland, Ohio 44109
United StatesActive - Recruiting
Local Institution - 0033
Cleveland 5150529, Ohio 5165418 44109
United StatesSite Not Available
Local Institution - 0047
Cleveland 5150529, Ohio 5165418 44106
United StatesSite Not Available
MetroHealth Medical Center
Cleveland 5150529, Ohio 5165418 44109
United StatesSite Not Available
Lehigh Valley Health Network
Allentown, Pennsylvania 18103
United StatesActive - Recruiting
Local Institution - 0051
Allentown, Pennsylvania 18103
United StatesSite Not Available
Lehigh Valley Health Network
Allentown 5178127, Pennsylvania 6254927 18103
United StatesSite Not Available

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