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Neoadjuvant nivolumab combination treatment in resectable non-small cell lung cancer patients: Defining optimal combinations and determinants of immunological response (NEOpredict-Lung)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513074-22-00
Acronym
CA224-063
Enrollment
90
Registered
2024-06-18
Start date
2019-12-02
Completion date
2025-11-27
Last updated
2025-10-23

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) of clinical stages IB, II and selected stage III A

Brief summary

Primary variable is the number of patients undergoing curatively intended surgery of non-small cell lung cancer within 43 days of initiation of study therapy.

Detailed description

Objective response rate (RECIST 1.1), Pathological response rate per ypTNM classification and per IASLC recommendations [..], R0 resection rate, Disease-free survival rate at 12 months per RECIST 1.1, Overall survival rate at 12 months, Safety and tolerability of preoperative immunotherapy, Morbidity and mortality within 90 days of curative surgery, Translational parameters [..]

Interventions

DRUGOPDIVO 10 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
Primary variable is the number of patients undergoing curatively intended surgery of non-small cell lung cancer within 43 days of initiation of study therapy.

Secondary

MeasureTime frame
Objective response rate (RECIST 1.1), Pathological response rate per ypTNM classification and per IASLC recommendations [..], R0 resection rate, Disease-free survival rate at 12 months per RECIST 1.1, Overall survival rate at 12 months, Safety and tolerability of preoperative immunotherapy, Morbidity and mortality within 90 days of curative surgery, Translational parameters [..]

Countries

Belgium, Germany, Netherlands

Outcome results

None listed

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