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Phase 2 Completed N=233 Randomized Quadruple-blind Treatment

A Study of Pembrolizumab Plus Epacadostat With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-06/ECHO-306-06)

Source: ClinicalTrials.gov NCT03322566 ↗
Enrolled (actual)
233
Serious AEs
47.4%
Results posted
Jan 2020
Primary outcomePrimary: Objective Response Rate (ORR) of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo — 26.4; 44.8 percentage of participants — p=0.9948

Summary

The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat with platinum-based chemotherapy versus pembrolizumab plus platinum-based chemotherapy plus placebo as first-line therapy in participants with metastatic non-small cell lung cancer (NSCLC).

Outcome Measures

OutcomeResultp-value
PRIMARY
Objective Response Rate (ORR) of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo
26.4; 44.8 0.9948
SECONDARY
Progression-free Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo
8.0; 8.2 0.94305
SECONDARY
Overall Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo
NA; NA 0.96272
SECONDARY
Duration of Response of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo
NA; 7.0
SECONDARY
Safety and Tolerability of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Experiencing Adverse Events (AEs)
89; 82
SECONDARY
Safety and Tolerability of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Discontinuing Study Drug Due to AEs
37; 35

Eligibility Criteria

Inclusion Criteria

  • Histologically or cytologically confirmed diagnosis of stage IV NSCLC without epidermal growth factor receptor (EGFR)-sensitizing mutation, ROS1 and/or anaplastic lymphoma kinase (ALK) translocation
  • Measurable disease based on RECIST 1.1
  • Life expectancy of at least 3 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate organ function per protocol-defined criteria.
  • Provide tumor tissue sample.

Exclusion Criteria

  • Known untreated central nervous system metastases and/or carcinomatous meningitis
  • History of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.
  • Symptomatic ascites or pleural effusion.
  • Known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
  • Active autoimmune disease that has required systemic treatment in past 2 years.
  • Has had an allogeneic tissue/solid organ transplant.
  • Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by the local health authority.
  • Has known history of or is positive for active Hepatitis B (HBsAg reactive) or has active Hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility.
  • History or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful.
  • Use of protocol-defined prior/concomitant therapy.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03322566). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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