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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03417037
• Other study ID #: CA017-062
• Secondary ID: 2017-003058-18
• Status: Withdrawn
• Phase: Phase 3
• Start date: May 24, 2018
• Est. completion date: August 20, 2025

Study information

• Verified date: April 2018
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 20, 2025
• Est. primary completion date: April 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• BMS-986205
Administered orally daily, 100 mg

Biological:
• Nivolumab
Specified dose on specified days

Drug:
• Chemotherapy
Platinum-based doublet chemotherapy

Locations

Country	Name	City	State
Australia	Local Institution	Brisbane	Queensland
Australia	Local Institution	Darlinghurst	New South Wales
Australia	Local Institution	Melbourne	Victoria
Australia	Local Institution	Murdoch	Western Australia
Australia	Local Institution	North Tamworth
Austria	Local Institution	Vienna
Austria	Local Institution	Wels
Brazil	Local Institution	Barretos	SAO Paulo
Brazil	Local Institution	Centro-porto Alegre	RIO Grande DO SUL
Brazil	Local Institution	Ijui	RIO Grande DO SUL
Brazil	Local Institution	Ipatinga	Minas Gerais
Brazil	Local Institution	Jd. Petropolis-Londrina	Parana
Brazil	Local Institution	Morumbi	SAO Paulo
Brazil	Local Institution	Porto Alegre	RIO Grande DO SUL
Brazil	Local Institution	Rio de Janeiro
Canada	Local Institution	Quebec
Czechia	Local Institution	Praha 2
France	Local Institution	Besancon
France	Local Institution	La Tronche
France	Local Institution	Paris Cedex 5
France	Local Institution	Pessac cedex
France	Local Institution	Pringy Cedex
France	Local Institution	Rennes Cedex 9
France	Local Institution	Saint Herblain
France	Local Institution	Toulon
Germany	Local Institution	Berlin
Germany	Local Institution	Gauting
Germany	Local Institution	Gera
Germany	Local Institution	Gottingen
Germany	Local Institution	Grosshansdorf
Germany	Local Institution	Hamburg
Germany	Local Institution	Heidelberg
Germany	Local Institution	Oldenburg
Germany	Local Institution	Paderborn
Germany	Local Institution	Wiesbaden
Greece	Local Institution	Athens
Greece	Local Institution	Athens
Greece	Local Institution	Thessaloniki
Italy	Local Institution	Modena
Italy	Local Institution	Monza (MB)
Italy	Local Institution	Napoli
Italy	Local Institution	Perugia
Italy	Local Institution	Ravenna
Italy	Local Institution	Reggio Emilia
Japan	Local Institution	Fukushima-shi	Fukushima
Japan	Local Institution	Kitaadachi-gun	Saitama
Japan	Local Institution	Morioka-shi	Iwate
Japan	Local Institution	Osaka-sayama-shi	Osaka
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Mexico	Local Institution	Merida	Yucatan
Spain	Local Institution	A Coruna	Galicia
Spain	Local Institution	Barcelona
Spain	Local Institution	Madrid
Spain	Local Institution	Majadahonda - Madrid
Spain	Local Institution	Malaga
Spain	Local Institution	Valencia
Switzerland	Local Institution	Basel
Taiwan	Local Institution	Taipei
Taiwan	Local Institution	Taipei
Turkey	Local Institution	?stanbul
Turkey	Local Institution	Adana
Turkey	Local Institution	Antalya
Turkey	Local Institution	Istanbul
United States	Local Institution	Boston	Massachusetts
United States	Local Institution	Bridgeton	Missouri
United States	Local Institution	Cleveland	Ohio
United States	Local Institution	Decatur	Georgia
United States	Local Institution	Fort Myers	Florida
United States	Local Institution	Fort Worth	Texas
United States	Local Institution	Gettysburg	Pennsylvania
United States	Local Institution	Greenville	South Carolina
United States	Local Institution	Jacksonville	Florida
United States	Local Institution	Lebanon	Tennessee
United States	Local Institution	Lincoln	Nebraska
United States	Local Institution	Louisville	Kentucky
United States	Local Institution	Lubbock	Texas
United States	Local Institution	Marietta	Georgia
United States	Local Institution	Saint Petersburg	Florida
United States	Local Institution	San Diego	California
United States	Local Institution	Tallahassee	Florida
United States	Local Institution	West Palm Beach	Florida
United States	Local Institution	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Brazil,  Canada,  Czechia,  France,  Germany,  Greece,  Italy,  Japan,  Korea, Republic of,  Mexico,  Spain,  Switzerland,  Taiwan,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		24 months
Primary	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		34 months
Secondary	Overall survival (OS) measured by the time between the date of randomization and the date of death due to any cause		Approximately 5 years
Secondary	Number of treatment-related adverse events (AE)		Approximately 5 years
Secondary	Number of treatment-related serious adverse events		Approximately 5 years

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form