Nivolumab and Epacadostat With Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Interventions
- Registration Number
- NCT03348904
- Lead Sponsor
- Incyte Corporation
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B Gemcitabine Platinum doublet chemotherapy Arm A Nivolumab Nivolumab plus epacadostat in combination with platinum doublet Arm C Carboplatin Nivolumab plus placebo in combination with platinum doublet chemotherapy. Arm B Paclitaxel Platinum doublet chemotherapy Arm C Placebo Nivolumab plus placebo in combination with platinum doublet chemotherapy. Arm A Pemetrexed Nivolumab plus epacadostat in combination with platinum doublet Arm A Epacadostat Nivolumab plus epacadostat in combination with platinum doublet Arm A Gemcitabine Nivolumab plus epacadostat in combination with platinum doublet Arm A Carboplatin Nivolumab plus epacadostat in combination with platinum doublet Arm A Cisplatin Nivolumab plus epacadostat in combination with platinum doublet Arm B Carboplatin Platinum doublet chemotherapy Arm A Paclitaxel Nivolumab plus epacadostat in combination with platinum doublet Arm B Cisplatin Platinum doublet chemotherapy Arm B Pemetrexed Platinum doublet chemotherapy Arm C Cisplatin Nivolumab plus placebo in combination with platinum doublet chemotherapy. Arm C Nivolumab Nivolumab plus placebo in combination with platinum doublet chemotherapy. Arm C Gemcitabine Nivolumab plus placebo in combination with platinum doublet chemotherapy. Arm C Paclitaxel Nivolumab plus placebo in combination with platinum doublet chemotherapy. Arm C Pemetrexed Nivolumab plus placebo in combination with platinum doublet chemotherapy.
- Primary Outcome Measures
Name Time Method Overall Survival (OS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B) Approximately 38 months Defined as the time from randomization to the date of death from any cause.
Progression-free Survival (PFS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B) Approximately 25 months 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.
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B) Approximately 25 months 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.
Duration of Response (DOR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B) Approximately 25 months 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.
Estimate of PFS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C) Approximately 25 months 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.
Estimate of OS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C) Approximately 38 months Defined as the time from randomization to the date of death from any cause.
Estimate of ORR of Nivolumab and Placebo in Combination With Chemotherapy (Arm C) Approximately 25 months 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.
Estimate of DOR of Nivolumab and Placebo in Combination With Chemotherapy (Arm C) Approximately 25 months 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.
Trial Locations
- Locations (2)
Pacific Cancer Medical Center, Inc
🇺🇸Anaheim, California, United States
Cancer Center of Kansas
🇺🇸Wichita, Kansas, United States