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

NCT03348904 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: CA2099NC/ECHO-309
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

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).

Conditions

Lung Cancer

Keywords

Non-small cell lung cancer; programmed cell death protein 1 (PD-1) antibody; indoleamine 2,3-dioxygenase (IDO) inhibitor

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Objective Response Rate (ORR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)

  Approximately 25 months

• Duration of Response (DOR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)

  Approximately 25 months

• Estimate of OS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)

  Approximately 38 months

• Estimate of PFS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)

  Approximately 25 months

• Estimate of ORR of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)

  Approximately 25 months

Study Arms (3)

Arm A

EXPERIMENTAL

Nivolumab plus epacadostat in combination with platinum doublet

Drug: Nivolumab; Drug: Epacadostat; Drug: Carboplatin; Drug: Cisplatin; Drug: Gemcitabine; Drug: Paclitaxel; Drug: Pemetrexed

Arm B

ACTIVE COMPARATOR

Platinum doublet chemotherapy

Drug: Carboplatin; Drug: Cisplatin; Drug: Gemcitabine; Drug: Paclitaxel; Drug: Pemetrexed

Arm C

EXPERIMENTAL

Nivolumab plus placebo in combination with platinum doublet chemotherapy.

Drug: Nivolumab; Drug: Placebo; Drug: Carboplatin; Drug: Cisplatin; Drug: Gemcitabine; Drug: Paclitaxel; Drug: Pemetrexed

Interventions

Nivolumab DRUG

Nivolumab administered intravenously at the protocol-defined dose every 3 weeks.

Also known as: BMS-936558

Arm A; Arm C

Epacadostat DRUG

Epacadostat administered orally at the protocol-defined dose twice daily.

Also known as: INCB024360

Arm A

Placebo DRUG

Matching placebo for epacadostat administered orally twice daily.

Arm C

Carboplatin DRUG

Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.

Arm A; Arm B; Arm C

Cisplatin DRUG

Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.

Arm A; Arm B; Arm C

Gemcitabine DRUG

Gemcitabine administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.

Arm A; Arm B; Arm C

Paclitaxel DRUG

Paclitaxel administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.

Arm A; Arm B; Arm C

Pemetrexed DRUG

Pemetrexed administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Optional continuation maintenance every 3 weeks, if eligible.

Arm A; Arm B; Arm C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead
• Bristol-Myers Squibb: collaborator

Study Sites (2)

Pacific Cancer Medical Center, Inc

Anaheim, California, 92801, United States

Location

Cancer Center of Kansas

Wichita, Kansas, 67214, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

Nivolumab; epacadostat; Carboplatin; Cisplatin; Gemcitabine; Paclitaxel; Pemetrexed

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Study Officials

• Sridhar K. Rabindran, PhD

  Bristol-Myers Squibb Research and Development

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: November 21, 2017
• Study Start: December 27, 2017
• Primary Completion: May 22, 2018
• Study Completion: May 22, 2018
• Last Updated: June 13, 2019
• Results First Posted: June 13, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)