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Prospective Phase-II Trial of induction chemotherapy and chemoradiotherapy plus/minus the PD-L1 antibody durvalumab followed by surgery or definitive chemoradiation boost and consolidation durvalumab in resectable stage III NSCLC (ESPADURVA)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513039-26-00
Acronym
ESPADURVA
Enrollment
90
Registered
2024-08-26
Start date
2019-11-25
Completion date
Unknown
Last updated
2025-09-22

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 stages IIIA (N2) and selected resectable stages IIIB

Brief summary

The primary endpoint is the progression-free survival rate

Detailed description

Overall survival, Occurrence of pulmonary adverse effects of grade > 3 according to CTCAE 5.0., Occurrence of immune therapy related adverse effects of grade > 3 according to CTCAE v.5.0., Adverse events with at least probable relationship to study procedures will counted in total and separate according to CTCAE criteria., Quality of life (QoL C30 and Qol-LC13) date will be analyzed descriptively calculation mean scores, standard deviations median minimum and maximum of the scores.

Interventions

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

Sponsors

Universitaetsklinikum Essen AöR
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the progression-free survival rate

Secondary

MeasureTime frame
Overall survival, Occurrence of pulmonary adverse effects of grade > 3 according to CTCAE 5.0., Occurrence of immune therapy related adverse effects of grade > 3 according to CTCAE v.5.0., Adverse events with at least probable relationship to study procedures will counted in total and separate according to CTCAE criteria., Quality of life (QoL C30 and Qol-LC13) date will be analyzed descriptively calculation mean scores, standard deviations median minimum and maximum of the scores.

Countries

Germany

Outcome results

None listed

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