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Clinical Trials/JPRN-jRCTs071210050
JPRN-jRCTs071210050
Active, not recruiting
Phase 2

A Phase II study of Durvalumab (MEDI4736) plus carboplatin and etoposide in elderly patients with extensive-stage small-cell lung cancer - LOGIK2003 (Turtle study)

Koichi Azuma0 sites40 target enrollmentAugust 5, 2021
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Conditionsextensive-stage small cell lung cancer

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
extensive-stage small cell lung cancer
Sponsor
Koichi Azuma
Enrollment
40
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 5, 2021
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Koichi Azuma

Eligibility Criteria

Inclusion Criteria

  • •1\) Histologically or cytologically confirmed small\-cell lung cancer
  • •2\) Extensive\-stage (ES)\-SCLC
  • •3\) No prior systemic chemotherapy for ES\-SCLC
  • •4\) 75 years of age or older
  • •5\) ECOG performance status of 0 to 1
  • •6\) With measurable lesions according to the RECIST criteria version 1\.1
  • •7\) Written informed consent
  • •8\) Expected to survive for 12 weeks or longer
  • •9\) Body weight \> 30kg

Exclusion Criteria

  • •1\) Synchronous or metachronous (within a year) malignancies
  • •2\) Active infection requiring systemic therapy and/or surgical procedures such as drainage
  • •3\) Active hepatitis B and C, and active tuberculosis
  • •4\) Interstitial lung disease on CT
  • •5\) Active autoimmune or inflammatory disease, or the history of autoimmune disease
  • •6\) Administration of immunosuppressants within 14 days prior to the protocol treatment
  • •7\) Grade2 or worse complications
  • •8\) Uncontrolled complications
  • •9\) Surgical treatment with general anesthesia within 14 days prior to the registration

Outcomes

Primary Outcomes

Not specified

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