Nivolumab and Epacadostat With Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03348904
• Other study ID #: CA2099NC/ECHO-309
• Status: Terminated
• Phase: Phase 3
• Start date: December 27, 2017
• Est. completion date: May 22, 2018

Study information

• Verified date: June 2019
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 22, 2018
• Est. primary completion date: May 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Nivolumab
Nivolumab administered intravenously at the protocol-defined dose every 3 weeks.
• Epacadostat
Epacadostat administered orally at the protocol-defined dose twice daily.
• Placebo
Matching placebo for epacadostat administered orally twice daily.
• Carboplatin
Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
• Cisplatin
Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
• Gemcitabine
Gemcitabine administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
• Paclitaxel
Paclitaxel administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
• Pemetrexed
Pemetrexed administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Optional continuation maintenance every 3 weeks, if eligible.

Locations

Country	Name	City	State
United States	Pacific Cancer Medical Center, Inc	Anaheim	California
United States	Cancer Center of Kansas	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Incyte Corporation	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)	Defined as the time from randomization to the date of death from any cause.	Approximately 38 months
Primary	Progression-free Survival (PFS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)	Defined as the time between the date of randomization and the first date of documented progression assessed by blinded independent central review, or death due to any cause, whichever occurs first.	Approximately 25 months
Secondary	Objective Response Rate (ORR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)	Defined as the proportion of participants who achieve a confirmed best response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by blinded independent central review.	Approximately 25 months
Secondary	Duration of Response (DOR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)	Defined as the time between the date of first confirmed response and the date of the first documented tumor progression (per RECIST v1.1) assessed by blinded independent central review or death due to any cause, whichever occurs first.	Approximately 25 months
Secondary	Estimate of OS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)	Defined as the time from randomization to the date of death from any cause.	Approximately 38 months
Secondary	Estimate of PFS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)	Defined as the time between the date of randomization and the first date of documented progression assessed by blinded independent central review or death due to any cause, whichever occurs first.	Approximately 25 months
Secondary	Estimate of ORR of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)	Defined as the proportion of participants who achieve a confirmed best response of CR or PR per RECIST v1.1 criteria as assessed by blinded independent central review.	Approximately 25 months
Secondary	Estimate of DOR of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)	Defined as the time between the date of first confirmed response and the date of the first documented tumor progression (per RECIST v1.1) assessed by blinded independent central review or death due to any cause, whichever occurs first.	Approximately 25 months