Clinical trial NCT03348904: Nivolumab and Epacadostat With Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Non-Small Cell Lung Cancer
Official title: A Phase 3, Randomized, Global Trial of Nivolumab and Epacadostat With Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in First-line Treatment of Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Lung Cancer
Keywords: Non-small cell lung cancer
programmed cell death protein 1 (PD-1) antibody
indoleamine 2,3-dioxygenase (IDO) inhibitor
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2017-11-21
Enrollment: 2
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: The purpose of this study was to evaluate the efficacy and safety of the combination of nivolumab plus epacadostat in combination with platinum chemotherapy compared with platinum chemotherapy alone, in participants with treatment-naïve Stage 4 or recurrent non-small cell lung cancer (NSCLC).


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed stage IV or recurrent NSCLC of squamous or non-squamous histology that is not amenable to therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
* No prior treatment with systemic anti-cancer therapy for Stage IV disease.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to1.
* Measurable disease by computed tomography or magnetic resonance imaging per RECIST v1.1.
* Documentation of program death ligand-1 (PD-L1) status of 0 to 49% by IHC performed by the central laboratory prior to randomization.
* Other protocol inclusion criteria may apply

Exclusion Criteria:

* Known epidermal growth factor receptor (EGFR) mutations sensitive to available targeted inhibitor therapy.
* Known ALK or ROS1 rearrangements sensitive to available targeted inhibitor therapy.
* Untreated central nervous system (CNS) metastases.
* Unevaluable PD-L1 status or PD-L1 status of ≥ 50% by IHC performed by a central laboratory.
* Carcinomatous meningitis.
* Active, known or suspected autoimmune disease.
* Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, IDO1 targeted agent, or any other antibody or drug targeting T cell co-stimulation or checkpoint pathways.
* History of allergy or hypersensitivity to platinum-containing compounds or study drug components.
* Physical and laboratory test findings outside the protocol-defined range.
* Other protocol exclusion criteria may apply.

Primary outcomes:
measure: Overall Survival (OS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)
timeFrame: Approximately 38 months
measure: Progression-free Survival (PFS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)
timeFrame: Approximately 25 months
Secondary outcomes:
measure: Objective Response Rate (ORR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)
timeFrame: Approximately 25 months
measure: Duration of Response (DOR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)
timeFrame: Approximately 25 months
measure: Estimate of OS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)
timeFrame: Approximately 38 months
measure: Estimate of PFS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)
timeFrame: Approximately 25 months
measure: Estimate of ORR of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)
timeFrame: Approximately 25 months
measure: Estimate of DOR of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)
timeFrame: Approximately 25 months
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center, Inc
state: California
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
Study officials:
affiliation: Bristol-Myers Squibb Research and Development
name: Sridhar K. Rabindran, PhD
role: STUDY_DIRECTOR
References: