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Pembrolizumab in Untreated Extensive SCLC

NCT02580994 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2023-12-11

No results posted yet for this study

Summary

This is a multicenter, open-label, two armed, controlled, and randomized phase II trial investigating the activity of pembrolizumab in combination with standard chemotherapy in Extensive Disease (ED)-SCLC.

Conditions

  • Small Cell Lung Cancer (SCLC)

Interventions

DRUG

Pembrolizumab

IV infusion at the dose of 200 mg on day 1 every 3 weeks

DRUG

cis/carboplatin and etoposide

Cisplatin 80 mg/m2 or Carboplatin Area Under the Curve (AUC) 5 IV infusion on day 1 Etoposide 100 mg/m2 IV infusion on day 1, 2 and 3

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-08
Primary Completion
2020-09-22
Completion
2022-06-22

Countries

  • France
  • Italy
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02580994 on ClinicalTrials.gov