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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 – IDEAR

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518804-32-00
Acronym
ESR-18-13828
Enrollment
30
Registered
2024-11-26
Start date
2021-02-16
Completion date
Unknown
Last updated
2024-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Brief summary

Rate of patients without Dose-Limiting Toxicity (DLT).

Detailed description

Presence of adverse events (AEs), including physical examinations, vital signs, electrocardiograms and laboratory clinically significant abnormalities., Objective Response Rate (ORR) (ORR = Complete response (CR) + partial response (PR)), Pathologic response rate (If tumor downsizing and surgical resection become best treatment option)., Proportion of enrolled patients starting RT/CRT within 4 - 5 weeks after durvalumab administration., Proportion of enrolled patients completing the clinical trial.

Interventions

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

Sponsors

Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Rate of patients without Dose-Limiting Toxicity (DLT).

Secondary

MeasureTime frame
Presence of adverse events (AEs), including physical examinations, vital signs, electrocardiograms and laboratory clinically significant abnormalities., Objective Response Rate (ORR) (ORR = Complete response (CR) + partial response (PR)), Pathologic response rate (If tumor downsizing and surgical resection become best treatment option)., Proportion of enrolled patients starting RT/CRT within 4 - 5 weeks after durvalumab administration., Proportion of enrolled patients completing the clinical trial.

Countries

Portugal

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026