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Clinical Trials/JPRN-jRCTs041200046
JPRN-jRCTs041200046
Active, not recruiting
Phase 2

Phase II Study of Multidisciplinary Therapy using Pembrolizumab for Patients with Synchronous Oligometastatic Stage IV Non-Small Cell Lung Cancer (TRAP OLIGO study) (WJOG11118L) - TRAP OLIGO study

Hirotsugu Kenmotsu0 sites30 target enrollmentSeptember 29, 2020
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Hirotsugu Kenmotsu
Enrollment
30
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 29, 2020
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Hirotsugu Kenmotsu

Eligibility Criteria

Inclusion Criteria

  • •Inclusion Criteria:
  • •1\.The age is within 20\-75 years.
  • •2\.Histologically confirmed non\-small cell lung cancer
  • •3\.No or unknown activating driver mutation: epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), proto\-oncogene receptor tyrosine kinase (ROS1\), mesenchymal epithelial transition receptor (MET)
  • •4\.Patients who have not received prior systemic chemotherapy
  • •5\.Synchronous oligo\-metastatic stage IV disease: maximum of three distant metastases\*
  • •\*The metastatic lesions will be counted as follows: each lesion will individually be counted as one, and intrathoracic lymph node involvement (defined here as hilar, mediastinal, or supraclavicular nodes, N1\-N3\) will collectively be counted as one.
  • •6\.The patient must be a suitable candidate for local therapy (radiotherapy and/or surgery) to every site of disease, as determined by a multidisciplinary tumor board (including specialists in thoracic oncology, radiology, radiotherapy and thoracic surgery).
  • •7\.No malignant ascites, leptomeningeal carcinomatosis and malignant pleural effusion Primary
  • •8\.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion Criteria

  • •1\.History of another primary malignancy within 5 years.
  • •2\.Active infection requiring therapy.
  • •3\.Active Hepatitis B or C.
  • •4\.Active autoimmune disease that has required systemic treatment
  • •5\.Unsuitable for thoracic radiotherapy by interstitial lung disease or chronic obstructive lung disease
  • •6\.Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of patient safety or study results.

Outcomes

Primary Outcomes

Not specified

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EUCTR2009-014582-51-DEFaculty of Medicine, Technische Universität München