Study of Durvalumab + Tremelimumab Durvalumab and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy

  • STATUS
    Recruiting
  • End date
    May 10, 2024
  • participants needed
    724
  • sponsor
    AstraZeneca
Updated on 25 November 2020
Investigator
AstraZeneca Clinical Study Information Center
Primary Contact
Research Site (2.0 mi away) Contact
+217 other location
prophylactic cranial irradiation
etoposide
chemoradiotherapy
cancer chemotherapy
limited stage small cell lung cancer

Summary

This is a Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with LS-SCLC Who Have Not Progressed Following Concurrent Chemoradiation Therapy

Details
Treatment Placebo, tremelimumab, durvalumab
Clinical Study IdentifierNCT03703297
SponsorAstraZeneca
Last Modified on25 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 130 yrs?
Gender: Male or Female
Do you have Small Cell Lung Cancer?
Do you have any of these conditions: sclc or small cell carcinoma of the lung or Small Cell Lung Cancer or small cell carcinoma?
Histologically or cytologically documented limited-stage small cell lung cancer (stage I-III)
Received 4 cycles of chemotherapy concurrent with radiotherapy, which must be completed within 1 to 42 days prior to randomization and the first dose of IP. Chemotherapy must contain platinum and IV etoposide. Radiotherapy must be either total 60-66 Gy over 6 weeks for the standard QD regimen or total 45 Gy over 3 weeks for hyperfractionated BD schedules
PCI may be delivered at the discretion of investigator and local standard of care, and must be conducted after the end of cCRT and completed between 1 to 42 days to first dose of IP
Have not progressed following definitive concurrent chemoradiation 5 .Life
expectancy 12 weeks at Day 1. 6. ECOG 0 or 1 at enrolment

Exclusion Criteria

Extensive-stage SCLC
Active or prior documented autoimmune or inflammatory disorders
Uncontrolled intercurrent illness, including but not limited to interstitial lung disease
Active infection including tuberculosis, HIV, hepatitis B and C
Patients who received sequential chemotherapy and radiotherapy (no overlap of RT with chemotherapy)
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Step 2 Get screened

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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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