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NCT03348904

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

Terminated Phase 3 Results posted Last updated 13 June 2019
What this trial tests

Phase 3 trial testing Nivolumab in Lung Cancer in 2 participants. Terminated before completion.

Timeline
27 December 2017
Primary endpoint
22 May 2018
22 May 2018

Quick facts

Lead sponsorIncyte Corporation
PhasePhase 3
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment2
Start date27 December 2017
Primary completion22 May 2018
Estimated completion22 May 2018
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Incyte Corporation — full company profile →

Who can join

18 and older, any sex, with Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Adverse events — posted to ClinicalTrials.gov

Time frame: From the initiation of study treatment until 30 days after last dose of study treatment or up to study termination date 22May2018.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Nivolumab + Epacadostat/Platinum Doublet Chemotherapy
Serious: 0
Deaths: 0
Platinum Doublet Chemotherapy
Serious: 1/2 (50%)
Deaths: 1/2
Nivolumab + Placebo Combination/Platinum Doublet Chemotherapy
Serious: 0
Deaths: 0

Serious adverse events (3 terms)

ReactionSystemNivolumab + Epacadostat/Pl…Platinum Doublet Chemother…Nivolumab + Placebo Combin…
DehydrationMetabolism and nutrition disorders———
Back painMusculoskeletal and connective tissue disorders———
OsteomyelitisMusculoskeletal and connective tissue disorders———
Other adverse events (13 terms — click to expand)

ReactionSystemNivolumab + Epacadostat/Pl…Platinum Doublet Chemother…Nivolumab + Placebo Combin…
ConstipationGastrointestinal disorders———
DyspnoeaRespiratory, thoracic and mediastinal disorders———
Flank painMusculoskeletal and connective tissue disorders———
NauseaGastrointestinal disorders———
VomitingGastrointestinal disorders———
Weight decreasedInvestigations———
AnaemiaBlood and lymphatic system disorders———
HypotensionVascular disorders———
PyrexiaGeneral disorders———
ThrombocytopeniaBlood and lymphatic system disorders———
Muscle spasmsMusculoskeletal and connective tissue disorders———
AnxietyPsychiatric disorders———
Peripheral sensory neuropathyNervous system disorders———

Most-reported serious reactions: Dehydration, Back pain, Osteomyelitis.

Data from ClinicalTrials.gov NCT03348904 adverse events section.

Sponsor's own 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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Immune checkpoint inhibitors: recent progress and potential biomarkers.
    Darvin P, Toor SM, Sasidharan Nair V, Elkord E. · · 2018 · cited 1495× · PMID 30546008 · DOI 10.1038/s12276-018-0191-1
  2. Indoleamine 2,3-dioxygenase 1 (IDO1) inhibitors in clinical trials for cancer immunotherapy.
    Tang K, Wu YH, Song Y, Yu B. · · 2021 · cited 276× · PMID 33883013 · DOI 10.1186/s13045-021-01080-8
  3. Amino acid metabolism in immune cells: essential regulators of the effector functions, and promising opportunities to enhance cancer immunotherapy.
    Yang L, Chu Z, Liu M, Zou Q, et al · · 2023 · cited 198× · PMID 37277776 · DOI 10.1186/s13045-023-01453-1
  4. The Use of Immune Checkpoint Inhibitors in Oncology and the Occurrence of AKI: Where Do We Stand?
    Franzin R, Netti GS, Spadaccino F, Porta C, et al · · 2020 · cited 142× · PMID 33162990 · DOI 10.3389/fimmu.2020.574271
  5. Primary and Acquired Resistance to Immunotherapy in Lung Cancer: Unveiling the Mechanisms Underlying of Immune Checkpoint Blockade Therapy.
    Boyero L, Sánchez-Gastaldo A, Alonso M, Noguera-Uclés JF, et al · · 2020 · cited 78× · PMID 33322522 · DOI 10.3390/cancers12123729
  6. Immunogenicity of cell death and cancer immunotherapy with immune checkpoint inhibitors.
    Catanzaro E, Beltrán-Visiedo M, Galluzzi L, Krysko DV. · · 2025 · cited 53× · PMID 39653769 · DOI 10.1038/s41423-024-01245-8
  7. Next generation immune-checkpoints for cancer therapy.
    Donini C, D'Ambrosio L, Grignani G, Aglietta M, et al · · 2018 · cited 50× · PMID 29951308 · DOI 10.21037/jtd.2018.02.79
  8. Targeting Indoleamine Dioxygenase and Tryptophan Dioxygenase in Cancer Immunotherapy: Clinical Progress and Challenges.
    Peng X, Zhao Z, Liu L, Bai L, et al · · 2022 · cited 38× · PMID 35965963 · DOI 10.2147/dddt.s373780

Verify or expand the search:

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03348904.

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