Clinical trial NCT03417037: An Immuno-Therapy Study of Experimental Medication BMS-986205 Given With Nivolumab With or Without Chemotherapy Compared to Chemotherapy in Participants With Previously Untreated Stage IV or Recurrent Non-Small Cell Lung Cancer
Official title: A Phase 3 Open Label, Randomized Study of BMS-986205 Combined With Nivolumab With or Without Chemotherapy Versus Chemotherapy in Participants With Previously Untreated Stage IV or Recurrent Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Lung Cancer
Non-Small Cell Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-01-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study of experimental medication BMS-986205 given with Nivolumab with or without chemotherapy compared to chemotherapy in participants with previously untreated stage IV or recurrent non-small cell lung cancer.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Histologically confirmed stage IV NSCLC per the 8th IASLC of squamous or nonsquamous histology
* Locally advanced disease with recurrence after chemoradiation therapy (stage IIIB disease, specifically refers to patients with no curative treatment options)
* No prior systemic anti-cancer therapy (including EGFR and ALK/ROS1 inhibitors) given as primary therapy for advanced or metastatic disease
* Participants must have biomarker test results available for randomization
* ECOG Performance Status of ≤ 1
* Measurable disease by CT or MRI per RECIST 1.1 criteria

Exclusion Criteria:

* Participants with known sensitizing EGFR mutations or known ALK/ROS1 rearrangements
* Participants with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
* Participants with an 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 untreated CNS metastases are excluded \[Participants are eligible if CNS metastases are adequately treated and participants are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to first treatment\]

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Objective response rate (ORR) measured by number of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group
timeFrame: 24 months
measure: Progression free survival (PFS) measured by the time between the date of randomization and the first date of documented progression, as determined by the Blinded Independent Central Review, or death, due to any cause, whichever occurs first
timeFrame: 34 months
Secondary outcomes:
measure: Overall survival (OS) measured by the time between the date of randomization and the date of death due to any cause
timeFrame: Approximately 5 years
measure: Number of treatment-related adverse events (AE)
timeFrame: Approximately 5 years
measure: Number of treatment-related serious adverse events
timeFrame: Approximately 5 years
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Local Institution
state: California
city: Fort Myers
country: United States
facility: Local Institution
state: Florida
city: Jacksonville
country: United States
facility: Local Institution
state: Florida
city: Saint Petersburg
country: United States
facility: Local Institution
state: Florida
city: Tallahassee
country: United States
facility: Local Institution
state: Florida
city: West Palm Beach
country: United States
facility: Local Institution
state: Florida
city: Decatur
country: United States
facility: Local Institution
state: Georgia
city: Marietta
country: United States
facility: Local Institution
state: Georgia
city: Wichita
country: United States
facility: Local Institution
state: Kansas
city: Louisville
country: United States
facility: Local Institution
state: Kentucky
city: Boston
country: United States
facility: Local Institution
state: Massachusetts
city: Bridgeton
country: United States
facility: Local Institution
state: Missouri
city: Lincoln
country: United States
facility: Local Institution
state: Nebraska
city: Cleveland
country: United States
facility: Local Institution
state: Ohio
city: Gettysburg
country: United States
facility: Local Institution
state: Pennsylvania
city: Greenville
country: United States
facility: Local Institution
state: South Carolina
city: Lebanon
country: United States
facility: Local Institution
state: Tennessee
city: Fort Worth
country: United States
facility: Local Institution
state: Texas
city: Lubbock
country: United States
facility: Local Institution
state: Texas
city: Darlinghurst
country: Australia
facility: Local Institution
state: New South Wales
city: Brisbane
country: Australia
facility: Local Institution
state: Queensland
city: Melbourne
country: Australia
facility: Local Institution
state: Victoria
city: Murdoch
country: Australia
facility: Local Institution
state: Western Australia
city: North Tamworth
country: Australia
facility: Local Institution
city: Vienna
country: Austria
facility: Local Institution
city: Wels
country: Austria
facility: Local Institution
city: Ipatinga
country: Brazil
facility: Local Institution
state: Minas Gerais
city: Jd. Petropolis-Londrina
country: Brazil
facility: Local Institution
state: Parana
city: Centro-porto Alegre
country: Brazil
facility: Local Institution
state: RIO Grande DO SUL
city: Ijui
country: Brazil
facility: Local Institution
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Local Institution
state: RIO Grande DO SUL
city: Barretos
country: Brazil
facility: Local Institution
state: SAO Paulo
city: Morumbi
country: Brazil
facility: Local Institution
state: SAO Paulo
city: Rio de Janeiro
country: Brazil
facility: Local Institution
city: Quebec
country: Canada
facility: Local Institution
city: Praha 2
country: Czechia
facility: Local Institution
city: Besancon
country: France
facility: Local Institution
city: La Tronche
country: France
facility: Local Institution
city: Paris Cedex 5
country: France
facility: Local Institution
city: Pessac cedex
country: France
facility: Local Institution
city: Pringy Cedex
country: France
facility: Local Institution
city: Rennes Cedex 9
country: France
facility: Local Institution
city: Saint Herblain
country: France
facility: Local Institution
city: Toulon
country: France
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Gauting
country: Germany
facility: Local Institution
city: Gera
country: Germany
facility: Local Institution
city: Gottingen
country: Germany
facility: Local Institution
city: Grosshansdorf
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Heidelberg
country: Germany
facility: Local Institution
city: Oldenburg
country: Germany
facility: Local Institution
city: Paderborn
country: Germany
facility: Local Institution
city: Wiesbaden
country: Germany
facility: Local Institution
city: Athens
country: Greece
facility: Local Institution
city: Athens
country: Greece
facility: Local Institution
city: Thessaloniki
country: Greece
facility: Local Institution
city: Modena
country: Italy
facility: Local Institution
city: Monza (MB)
country: Italy
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution
city: Perugia
country: Italy
facility: Local Institution
city: Ravenna
country: Italy
facility: Local Institution
city: Reggio Emilia
country: Italy
facility: Local Institution
city: Fukushima-shi
country: Japan
facility: Local Institution
state: Fukushima
city: Morioka-shi
country: Japan
facility: Local Institution
state: Iwate
city: Osaka-sayama-shi
country: Japan
facility: Local Institution
state: Osaka
city: Kitaadachi-gun
country: Japan
facility: Local Institution
state: Saitama
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Merida
country: Mexico
facility: Local Institution
state: Yucatan
city: A Coruna
country: Spain
facility: Local Institution
state: Galicia
city: Barcelona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Majadahonda - Madrid
country: Spain
facility: Local Institution
city: Malaga
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: Basel
country: Switzerland
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: ?stanbul
country: Turkey
facility: Local Institution
city: Adana
country: Turkey
facility: Local Institution
city: Antalya
country: Turkey
facility: Local Institution
city: Istanbul
country: Turkey
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: