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Neoadjuvant Immunotherapy With Durvalumab (MEDI4736) in Non-Surgical Early Stage or Locally Advanced Non-Small Cell Lung Cancer (NSCLC) Followed by Radical Radiotherapy or Chemoradiotherapy

NCT05267392 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-03-04

No results posted yet for this study

Summary

This study proposes to evaluate the safety and efficacy of an anti-PD-L1 (durvalumab) agent as neoadjuvant therapy in patients diagnosed with localized NSCLC who are planned to undergo radical RT or CRT. The hypothesis to be tested for the primary objective is that the treatment of durvalumab followed by RT/CRT will be safe and well tolerated in subjects with NSCLC.

Conditions

Interventions

DRUG

Durvalumab

Patients will receive 1500 mg of durvalumab (MEDI4736) via IV infusion

OTHER

standard of care RT/RCT

standard of care RT/RCT

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Instituto Portugues de Oncologia, Francisco Gentil, Porto

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-16
Primary Completion
2023-07-31
Completion
2024-01-31

Countries

  • Portugal

Study Locations

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Entities

Drugs
Diseases
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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 NCT05267392 on ClinicalTrials.gov