Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Recurrence

Death

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Antineoplastic Agents

Micronutrients

Hematinics

Vitamins

Antibodies

Gemcitabine

Paclitaxel

Carboplatin

Pemetrexed

Albumin-Bound Paclitaxel

Cisplatin

Nivolumab

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Nivolumab plus epacadostat in combination with platinum doublet

Nivolumab plus placebo in combination with platinum doublet chemotherapy.

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

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

Epacadostat

Matching placebo for epacadostat administered orally twice daily.

Placebo

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

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

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

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

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

Sridhar K. Rabindran, PhD

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).

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

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)

Defined as the time from randomization to the date of death from any cause.

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.

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.

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.

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.

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.

Bristol-Myers Squibb

Incyte Corporation

Nivolumab + Epacadostat/Platinum Doublet Chemotherapy included the following:

Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. Epacadostat was administered orally at the protocol-defined dose twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.

Optional continuation maintenance was available every 3 weeks, if eligible.

Nivolumab + Epacadostat/Platinum Doublet Chemotherapy

Platinum Doublet Chemotherapy included the following:

Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.

Optional continuation maintenance was available every 3 weeks, if eligible.

Platinum Doublet Chemotherapy

Nivolumab plus placebo in combination with platinum doublet chemotherapy included:

Nivolumab was administered intravenously at the protocol-defined dose every 3 weeks. : Matching placebo for epacadostat was administered orally twice daily. Carboplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Cisplatin was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Gemcitabine was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Paclitaxel was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles. Pemetrexed was administered intravenously at the protocol-defined dose every 3 weeks up to 4 cycles.

Optional continuation maintenance was available every 3 weeks, if eligible.

Nivolumab + Placebo Combination/Platinum Doublet Chemotherapy

Total

Age, Categorical

Sex: Female, Male

White or Caucasian

Race/Ethnicity, Customized

Study Director

All randomized participants; Arm A did not enroll any participants in the study and as a result no comparisons were performed and since the study was terminated early no efficacy analyses were conducted.

Overall Survival (OS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)

Progression-free Survival (PFS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)

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

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

All randomized participants; Arm C did not enroll any participants in the study and as a result no analyses were performed and since the study was terminated early no efficacy analyses were conducted.

Spots Global Cancer Trial Database for Nivolumab and Epacadostat With Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Non-Small Cell Lung Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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