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An Open-Label, Multi-Drug, Biomarker-Directed, Multi-Centre Phase II Umbrella Study in Patients with Non-Small Cell Lung Cancer, who Progressed on an anti-PD-1/PD-L1 Containing Therapy (HUDSON).

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509004-15-00
Acronym
D6185C00001
Enrollment
172
Registered
2024-08-09
Start date
2018-02-20
Completion date
Unknown
Last updated
2025-06-05

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

Conditions

Patients with non-small cell lung cancer (NSCLC).

Brief summary

Endpoint based on Response Evaluation Criteria in Solid Tumours (RECIST 1.1) Objective response rate (ORR)

Detailed description

Overall Survival (OS)., Endpoints based on RECIST 1.1 including: Disease control rate (DCR), Endpoints based on RECIST 1.1 including: Best percentage change in tumour size, Endpoints based on RECIST 1.1 including: Duration of response (DoR), Endpoints based on RECIST 1.1 including: Progression free survival (PFS).

Interventions

DRUGINFLIXIMAB
DRUGDS-8201a
DRUGMYCOPHENOLATE MOFETIL
DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

Sponsors

AstraZeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Endpoint based on Response Evaluation Criteria in Solid Tumours (RECIST 1.1) Objective response rate (ORR)

Secondary

MeasureTime frame
Overall Survival (OS)., Endpoints based on RECIST 1.1 including: Disease control rate (DCR), Endpoints based on RECIST 1.1 including: Best percentage change in tumour size, Endpoints based on RECIST 1.1 including: Duration of response (DoR), Endpoints based on RECIST 1.1 including: Progression free survival (PFS).

Countries

Austria, France, Germany, Spain

Outcome results

None listed

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