Phase II Umbrella Study of Novel Anti-cancer Agents in Patients With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy (HUDSON)
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ClinicalTrials.gov Identifier: NCT03334617 |
Recruitment Status :
Recruiting
First Posted : November 7, 2017
Last Update Posted : January 5, 2023
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Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | September 22, 2017 | ||||||||||||||
First Posted Date ICMJE | November 7, 2017 | ||||||||||||||
Last Update Posted Date | January 5, 2023 | ||||||||||||||
Actual Study Start Date ICMJE | December 18, 2017 | ||||||||||||||
Estimated Primary Completion Date | January 2, 2026 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
Assessment of the efficacy of each treatment by evaluation of objective response rate [ Time Frame: 12 weeks ] Endpoint based on Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
Objective response rate (ORR)
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Original Primary Outcome Measures ICMJE |
Assessment of the efficacy of each treatment by evaluation of objective response rate [ Time Frame: 12 weeks ] Endpoint based on modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
Objective response rate (ORR)
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Change History | |||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures |
Incidence of adverse events/serious adverse events to assess the safety and tolerability of each treatment [ Time Frame: Through to study completion, up to 3.5 years. ] Physical examinations, laboratory findings, and vital signs AEs/SAEs collected throughout the study, from informed consent until the safety follow-up visit
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Original Other Pre-specified Outcome Measures | Same as current | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | Phase II Umbrella Study of Novel Anti-cancer Agents in Patients With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy | ||||||||||||||
Official Title ICMJE | 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). | ||||||||||||||
Brief Summary | This is an open-label, multi-centre, umbrella Phase II study in patients with metastatic NSCLC who have progressed on an anti-PD-1/PD-L1 containing therapy. This study is modular in design, allowing initial assessment of the efficacy, safety, and tolerability of multiple treatment arms. | ||||||||||||||
Detailed Description | This is an open-label, multi-centre, umbrella Phase II study in patients with metastatic non-small cell lung cancer (NSCLC) who have progressed on an anti-programmed cell death-1/anti-programmed cell death ligand 1 (anti-PD-1/PD-L1) containing therapy. This study is modular in design, consisting of a number of treatment cohorts, allowing evaluation of the efficacy, safety, and tolerability of multiple treatment arms. There is currently no established therapy for patients who have received immune checkpoint inhibitors and platinum-doublet therapies, and novel treatments are urgently needed. This protocol has a modular design, with the potential for future treatment arms to be added via protocol amendment. |
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Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Intervention Model Description: This is an open-label, multi-centre, umbrella Phase II study in patients with metastatic NSCLC who have progressed on an anti-PD-1/PD-L1 containing therapy. This study is modular in design, allowing initial assessment of the efficacy, safety, and tolerability of multiple treatment arms. Within each module, there will be treatment cohorts. Primary Purpose: Treatment |
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Condition ICMJE | Non-Small Cell Lung Cancer | ||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||
Estimated Enrollment ICMJE |
570 | ||||||||||||||
Original Estimated Enrollment ICMJE |
200 | ||||||||||||||
Estimated Study Completion Date ICMJE | January 2, 2026 | ||||||||||||||
Estimated Primary Completion Date | January 2, 2026 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 99 Years (Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Austria, Canada, France, Germany, Israel, Korea, Republic of, Spain, United States | ||||||||||||||
Removed Location Countries | |||||||||||||||
Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT03334617 | ||||||||||||||
Other Study ID Numbers ICMJE | D6185C00001 2017-002208-28 ( EudraCT Number ) 138050 ( Registry Identifier: IND ) |
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Has Data Monitoring Committee | Yes | ||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | AstraZeneca | ||||||||||||||
Original Responsible Party | Same as current | ||||||||||||||
Current Study Sponsor ICMJE | AstraZeneca | ||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||
Investigators ICMJE |
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PRS Account | AstraZeneca | ||||||||||||||
Verification Date | December 2022 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |