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
Local Institution - 0043
Belo Horizonte, Minas Gerais 30380-490
BrazilSite Not Available
Local Institution - 0038
Porto Alegre, Rio Grande Do Sul 90035-903
BrazilSite Not Available
Local Institution - 0037
Barretos, São Paulo 14784400
BrazilSite Not Available
Local Institution - 0034
São Paulo, 01246-000
BrazilSite Not Available
Local Institution - 0068
Antofagasta, AN 1240000
ChileSite Not Available
Local Institution - 0067
Santiago, Región Metropolitana De Santiago 8420383
ChileSite Not Available
Local Institution - 0069
Viña del Mar, Valparaíso 2520598
ChileSite Not Available
Local Institution - 0065
Dijon, Côte-d'Or 21079
FranceSite Not Available
Local Institution - 0003
Suresnes, Hauts-de-Seine 92151
FranceSite Not Available
Local Institution - 0010
Paris, Île-de-France 75014
FranceSite Not Available
Local Institution - 0012
Athens, Attikí 115 27
GreeceSite Not Available
Local Institution - 0013
Chaidari, Attikí 12462
GreeceSite Not Available
Local Institution - 0011
Thessaloniki, Kentrikí Makedonía 540 07
GreeceSite Not Available
Local Institution - 0014
Larissa, Thessalía 41110
GreeceSite Not Available
Local Institution - 0015
Meldola, Emilia-Romagna 47014
ItalySite Not Available
Local Institution - 0057
Udine, Friuli-Venezia Giulia 33100
ItalySite Not Available
Local Institution - 0020
Bergamo, Lombardia 24127
ItalySite Not Available
Local Institution - 0019
Firenze, Toscana 50134
ItalySite Not Available
Local Institution - 0017
Novara, 28100
ItalySite Not Available
Local Institution - 0025
Guadalajara, Jalisco 44630
MexicoSite Not Available
Local Institution - 0058
Monterrey, Nuevo León 64460
MexicoSite Not Available
Local Institution - 0027
Merida, Yucatán 97070
MexicoSite Not Available
Local Institution - 0024
Mexico, 06700
MexicoSite Not Available
Local Institution - 0022
Puebla, 72424
MexicoSite Not Available
Local Institution - 0081
Warszawa, Mazowieckie 03-411
PolandSite Not Available
Local Institution - 0080
Prabuty, Pomorskie 82-550
PolandSite Not Available
Local Institution - 0079
Łódź, Łódzkie 93-338
PolandSite Not Available
Local Institution - 0073
Bucharest, București 022328
RomaniaSite Not Available
Local Institution - 0076
Florești, Cluj 407280
RomaniaSite Not Available
Local Institution - 0077
Craiova, Dolj 200542
RomaniaSite Not Available
Local Institution - 0075
Bucharest, 020335
RomaniaSite Not Available
Local Institution - 0074
Cluj, 400015
RomaniaSite Not Available
Local Institution - 0078
Iași, 700483
RomaniaSite Not Available
Local Institution - 0009
Sandton, 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
Local Institution - 0084
Rondebosch, Western Cape 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
Alaska Oncology and Hematology
Anchorage, Alaska 99508
United StatesActive - Recruiting
Local Institution - 0032
Anchorage, Alaska 99508
United StatesSite Not Available
Local Institution - 0062
Los Angeles, California 90033
United StatesSite Not Available
Local Institution - 0052
Boise, Idaho 83706
United StatesSite Not Available
Local Institution - 0063
Boise, Idaho 83702
United StatesSite Not Available
Local Institution - 0064
Post Falls, Idaho 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
Local Institution - 0051
Allentown, Pennsylvania 18103
United StatesSite Not Available
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