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AZD2811 and Durvalumab (MEDI4736) Combination Therapy in Relapsed Small Cell Lung Cancer

NCT04525391 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2022-02-25

No results posted yet for this study

Summary

Samsung Medical Centre, Seoul, Korea. Additional 0\~5 Korea Lung Cancer Consortium (KLCC) centres in Korea Up to 40 subjects will be enrolled in two-stages (first stage: 19 evaluable subjects and second stage: 17 evaluable subjects and additional 4 subjects considering the drop out rate) If the study is conducted as de-escalated dosage (Durvalumab 1120mg) after the safety run-in, number of the patients will be counted from the second safety-run in phase.

Conditions

  • SCLC, Recurrent

Interventions

DRUG

Durvalumab+AZD2811 to SCLC patients

AZD2811 must NOT be infused through a 0.2-µm or 0.22-µm filter and therefore durvalumab and AZD2811 MUST be infused through different infusion lines. In order not to exceed the endotoxin limit, durvalumab and AZD2811 mustbe administered consecutively. Durvalumab is administered first over 1 hour, followed by AZD2811 administered over 2 hours. AZD2811 should be administered at 30 minutes after the end of the durvalumab infusion, as long as there are no acute infusion reactions to durvalumab.

Sponsors & Collaborators

  • Se-Hoon Lee

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-18
Primary Completion
2022-01-14
Completion
2022-01-14

Countries

  • South Korea

Study Locations

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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 NCT04525391 on ClinicalTrials.gov