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UNKNOWNPHASE2

Chemoradiation With Durvalumab Followed by Durvalumab Maintenance for Limited Disease Small Cell Lung Cancer

Phase II Trial of Durvalumab (MEDI4736) Maintenance Therapy After Concurrent Chemoradiation Therapy With Durvalumab (MEDI4736) for Limited Disease-small Cell Lung Cancer

NCT03585998•Samsung Medical Center

View on ClinicalTrials.gov

Summary

This is a single arm Phase II study, in which 4 cycles of chemotherapy (Etoposide and Cisplatin) and durvalumab with thoracic radiotherapy (52.2Gy, 2.1Gy/Fx) start at the 3rd cycle of chemotherapy and durvalumab for limited disease-small cell lung cancer. Four weeks after completion of concurrent chemoradiation therapy, patients will receive durvalumab consolidation monotherapy every 4 weeks until progression of disease or unacceptable toxicity up to the maximum duration of 2 years since enrollment.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Written informed consent and any locally-required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
•2. Histologically confirmed small cell lung cancer
•3. Limited disease, defined as disease confined to one hemithorax, the mediastinum, and the bilateral supraclavicular fossae.
•4. Age \> 19 years at time of study entry
•5. ECOG performance status of 0 to 1
•6. Body weight \>30kg
•7. Adequate normal organ and marrow function as defined below:
•* Haemoglobin ≥ 9.0 g/dL
•* Absolute neutrophil count (ANC ≥ 1.5 (or 1.0) x (\> 1500 per mm3)
•* Platelet count ≥ 100 (or 75) x 109/L (\>75,000 per mm3)
+38 more criteria

Exclusion Criteria

•1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
•2. Patients with extensive disease small-cell lung cancer
•3. Patients who previously received radiotherapy to the thorax or chemotherapy for small cell lung cancer
•4. Participation in another clinical study with an investigational product at any time
•5. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study

Locations (1)

Samsung Medical Center

Seoul, MA, South Korea

Key Dates

Start Date

June 19, 2018

Primary Completion Date

June 19, 2021

Completion Date

December 19, 2021

Last Updated

March 2, 2020

Enrollment

ACTUAL participants

Conditions

Small Cell Lung Cancer

Interventions

Durvalumab

DRUG

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Chemoradiation With Durvalumab Followed by Durvalumab Maintenance for Limited Disease Small Cell Lung Cancer

Inclusion Criteria

Exclusion Criteria

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy