Description:
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).
Title
- Brief Title: 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)
Clinical Trial IDs
- ORG STUDY ID:
CA2099NC/ECHO-309
- NCT ID:
NCT03348904
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Nivolumab | BMS-936558 | Arm A |
Epacadostat | INCB024360 | Arm A |
Placebo | | Arm C |
Carboplatin | | Arm A |
Cisplatin | | Arm A |
Gemcitabine | | Arm A |
Paclitaxel | | Arm A |
Pemetrexed | | Arm A |
Purpose
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).
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A | Experimental | Nivolumab plus epacadostat in combination with platinum doublet | - Nivolumab
- Epacadostat
- Carboplatin
- Cisplatin
- Gemcitabine
- Paclitaxel
- Pemetrexed
|
Arm B | Active Comparator | Platinum doublet chemotherapy | - Carboplatin
- Cisplatin
- Gemcitabine
- Paclitaxel
- Pemetrexed
|
Arm C | Experimental | Nivolumab plus placebo in combination with platinum doublet chemotherapy. | - Nivolumab
- Placebo
- Carboplatin
- Cisplatin
- Gemcitabine
- Paclitaxel
- Pemetrexed
|
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Overall Survival (OS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B) |
Time Frame: | Approximately 38 months |
Safety Issue: | |
Description: | Defined as the time from randomization to the date of death from any cause. |
Secondary Outcome Measures
Measure: | Objective Response Rate (ORR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B) |
Time Frame: | Approximately 25 months |
Safety Issue: | |
Description: | 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. |
Measure: | Duration of Response (DOR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B) |
Time Frame: | Approximately 25 months |
Safety Issue: | |
Description: | 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. |
Measure: | Estimate of OS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C) |
Time Frame: | Approximately 38 months |
Safety Issue: | |
Description: | Defined as the time from randomization to the date of death from any cause. |
Measure: | Estimate of PFS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C) |
Time Frame: | Approximately 25 months |
Safety Issue: | |
Description: | 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. |
Measure: | Estimate of ORR of Nivolumab and Placebo in Combination With Chemotherapy (Arm C) |
Time Frame: | Approximately 25 months |
Safety Issue: | |
Description: | 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. |
Measure: | Estimate of DOR of Nivolumab and Placebo in Combination With Chemotherapy (Arm C) |
Time Frame: | Approximately 25 months |
Safety Issue: | |
Description: | 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. |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Terminated |
Lead Sponsor: | Incyte Corporation |
Trial Keywords
- Non-small cell lung cancer
- programmed cell death protein 1 (PD-1) antibody
- indoleamine 2,3-dioxygenase (IDO) inhibitor
Last Updated
June 13, 2019