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Survival imProvement in Lung cancEr iNduced by DenOsUmab theRapy

NCT02129699 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 595

Last updated 2024-09-19

Study results available
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Summary

The purpose of this study is to investigate how well the standard treatment (platinum-based doublet chemotherapy) in combination with denosumab works compared with the standard treatment alone in patients with a type of lung cancer called "non small cell lung cancer" (NSCLC) that has spread to other parts of the body.

Conditions

  • Lung Cancer Non-small Cell Stage IV

Interventions

DRUG

Denosumab

Denosumab: 120 mg, s.c. every 3-4 weeks (in cycle 1 additional dose on day 8) until unacceptable toxicity, patient refusal or patient's death (max. 4 years 3 months).

OTHER

None, standard chemotherapy only

Possible standard chemotherapies (3 weeks cycles, duration: 4 - 6 cycles): Cisplatin 75 mg/m2 as an infusion on day 1 Gemcitabine 1250 mg/m2 as an infusion days 1 and 8 or Carboplatin AUC 5 as an infusion on day 1 Gemcitabine 1000 mg/m2 as an infusion days 1 and 8 or Cisplatin 75 mg/m2 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1 or Carboplatin AUC 5 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1

Sponsors & Collaborators

  • European Organisation for Research and Treatment of Cancer - EORTC

    collaborator NETWORK

  • Amgen

    collaborator INDUSTRY

  • ETOP IBCSG Partners Foundation

    lead NETWORK

Principal Investigators

  • Solange Peters, MD, PhD · Trial Chair, CHUV Lausanne, Switzerland

  • Mary O'Brien, MD · EORTC Trial Co-Chair, Royal Marden Hospital, Sutton, UK

  • Sarah Danson, PhD · EORTC Trial Co-Chair, University of Sheffield, Sheffield, UK

  • Rolf Stahel, MD · Trial Co-Chair, University Hospital of Zuerich, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-06
Primary Completion
2020-02-29
Completion
2020-02-29

Countries

  • Austria
  • Belgium
  • France
  • Germany
  • Ireland
  • Italy
  • Poland
  • Slovenia
  • Spain
  • Switzerland
  • 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 NCT02129699 on ClinicalTrials.gov