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Active Clinical Trials

Pembrolizumab Plus Epacadostat Alone or With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-02/ECHO-306)

Active NCT:
03322566
Allegheny General Hospital
Allegheny General Hospital

Jefferson Hospital
Jefferson Hospital

West Penn Hospital
West Penn Hospital

Wexford Health + Wellness Pavilion
Wexford Health + Wellness Pavilion

Category:
Cancer - Lung
Sponsor: 
Incyte Corporation
Contact: 

For more information, please contact Mara Yerk at 412-578-5393 or Mara.Yerk@ahn.org.

715-05/ECHO-306-05; A Randomized Phase 32 Study of the Combination of Pembrolizumab (MK-3475) Plus Epacadostat (INCB024360) Alone or with Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo as First-Line Treatment in Patients with Metastatic Non-Small Cell Lung Cancer

Purpose: 

This is a randomized, active-controlled, partial double-blind, multi-site study independently comparing the combinations of epacadostat + pembrolizumab + platinumbased chemotherapy VERSUS pembrolizumab + platinumbased chemotherapy + placebo as first-line treatment in participants with metastatic NSCLC.

This Phase 2 study will be conducted in participants with stage IV NSCLC who have not previously received systemic therapy for their metastatic disease and in whom EGFR, ALK, or ROS1 directed therapy is not indicated.

Ages Eligible for Study:  18 Years and older   (Adult, Senior)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

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.