Brentuximab Vedotin in Early Stage Hodgkin Lymphoma (RADAR)

May 29, 2026 updated by: University College, London

A Randomised Phase III Trial With a PET Response Adapted Design Comparing ABVD +/- ISRT With A2VD +/- ISRT in Patients With Previously Untreated Stage IA/IIA Hodgkin Lymphoma

RADAR is a multicentre, international, randomised, open-label phase III clinical trial composed of 2 trials running in parallel. Trial 1 will be led and sponsored by University College London (UCL) and conducted in Europe and Australia/New Zealand. Trial 2 will be led by the Canadian Cancer Trials Group (CCTG) and conducted in North America, with CCTG the regulatory sponsor in Canada, and University of Miami the regulatory sponsor and IND holder in the US. Datasets from Trial 1 and Trial 2 will be combined to achieve the total sample size. Data analysis will be performed by UCL and therefore UCL is responsible for the clinicaltrials.gov entry.

Eligible patients will be randomised to receive either ABVD or A2VD chemotherapy.

An interim PET-CT scan will be performed after 2 cycles of treatment, which will be used to adapt subsequent treatment. Patients will receive a total of 3-4 cycles of chemotherapy and may also receive involved site radiotherapy as consolidation.

Patients will be followed up for a minimum of 5 years after treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Eligible patients will be randomised to receive either ABVD chemotherapy (doxorubicin, bleomycin, vinblastine and dacarbazine) or A2VD chemotherapy (doxorubicin, brentuximab vedotin, vinblastine and dacarbazine, with growth factor support).

If patients agree, they will have a PET-CT scan after 1 cycle (PET1). The result of this scan will be blinded and used for exploratory endpoints only. Treatment will not be influenced by the result of this scan.

All patients will have a PET-CT scan after 2 cycles of treatment (PET2) which will be centrally reviewed. The Deauville score from central review will be used to risk adapt subsequent therapy as follows:

  • Patients with Deauville score 1-3 will have one further cycle of their randomised chemotherapy and then enter follow up.
  • Patients with Deauville score 4 will have two further cycles of their randomised chemotherapy followed by involved site radiotherapy
  • Patients with Deauville score 5 will be withdrawn from trial treatment. They will have further treatment at their treating clinician's discretion and will enter follow up for the trial.

Patients with Deauville score 4 on PET2 will have a final PET-CT scan to confirm adequate treatment response.

Patients will be followed up for a minimum of 5 years after completing treatment.

Study Type

Interventional

Enrollment (Estimated)

1042

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Adelaide, Australia, 5000
        • Recruiting
        • Royal Adelaide Hospital
        • Contact:
          • Pratyush Giri
        • Principal Investigator:
          • Pratyush Giri
      • Box Hill, Australia, VIC 3128
        • Recruiting
        • Box Hill Hospital
        • Contact:
          • Denise Lee
        • Principal Investigator:
          • Denise Lee
      • Brisbane, Australia, QLD 4006
        • Recruiting
        • Royal Brisbane and Women's Hospital
        • Principal Investigator:
          • Nicholas Weber
        • Contact:
          • Nicholas Weber
      • Darwin, Australia, NT 0810
        • Recruiting
        • Royal Darwin Hospital
        • Contact:
          • Emma Palfreyman
        • Principal Investigator:
          • Emma Palfreyman
      • Liverpool, Australia
        • Recruiting
        • Liverpool Hospital
        • Contact:
        • Principal Investigator:
          • Vu M Hua
      • Melbourne, Australia, VIC 3021
        • Recruiting
        • Sunshine Hospital (Western Health)
        • Contact:
          • Michael Gilbertson
        • Principal Investigator:
          • Michael Gilbertson
      • Sydney, Australia, NSW 2139
        • Recruiting
        • Concord Repatriation General Hospital
        • Contact:
          • Nicole Wong Doo
        • Principal Investigator:
          • Nicole Wong Doo
      • Sydney, Australia, NSW 2217
        • Recruiting
        • St George Hospital
        • Contact:
          • Fernando Roncolato
        • Principal Investigator:
          • Fernando Roncolato
    • New South Wales
      • Saint Leonards, New South Wales, Australia, 2065
        • Recruiting
        • Royal North Shore Hospital
        • Principal Investigator:
          • Keith Fay
        • Contact:
          • Keith Fay
    • Queensland
      • Townsville, Queensland, Australia, QLD 4814
  • Belgium
      • Antwerp, Belgium
        • Recruiting
        • Universitair Ziekenhuis Antwerpen
        • Contact:
        • Principal Investigator:
          • Eva De Backer
      • Antwerp, Belgium
        • Recruiting
        • Ziekenhuis Netwerk Antwerpen
        • Principal Investigator:
          • Ka Lung Wu
        • Contact:
      • Leuven, Belgium
      • Namur, Belgium
    • West Flanders
      • Roeselare, West Flanders, Belgium, Deltalaan 1, 8800
        • Recruiting
        • AZ Delta Campus Rumbeke
        • Principal Investigator:
          • Caressa Meert
        • Contact:
  • Canada
      • Ottawa, Canada, K1Y 4E9
        • Recruiting
        • Ottowa Hospital Research Institute
        • Contact:
          • Ashley-Ann Emond
        • Principal Investigator:
          • Isabelle Bence-Bruckler
      • Saint John, Canada, E2L 4L2
        • Recruiting
        • Saint John Regional Hospital
        • Contact:
          • Sharon Turnell
        • Principal Investigator:
          • Alfonso Riviera Duarte
      • Toronto, Canada, M5G 2M9
        • Recruiting
        • University Health Network Princess Margaret Cancer Centre
        • Contact:
          • Marie Kirchmeyer
        • Principal Investigator:
          • Michael Crump
      • Vancouver, Canada, V5Z 4E6
        • Recruiting
        • Vancouver Cancer Centre
        • Contact:
          • Niamh McMahon
        • Principal Investigator:
          • Kerry Savage
      • Winnipeg, Canada, R3E 0V9
        • Recruiting
        • CancerCare Manitoba
        • Contact:
          • Tianna Rarama
        • Principal Investigator:
          • Leonard Minuk
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Recruiting
        • QEII Health Sciences Centre
        • Contact:
          • Becky Veinot
        • Principal Investigator:
          • Nicholas Forward
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Recruiting
        • Juravinski Cancer Centre
        • Contact:
          • Edna Wilson
        • Principal Investigator:
          • Joanne Britto
  • Denmark
      • Aarhus, Denmark
        • Recruiting
        • Aarhus University Hospitak Skjeby
        • Contact:
        • Principal Investigator:
          • Peter Kamper
      • Copenhagen, Denmark
  • Ireland
      • Dublin, Ireland
        • Recruiting
        • St. Vincent's University Hospital
        • Principal Investigator:
          • Liam Smyth
        • Contact:
      • Dublin, Ireland
        • Recruiting
        • St James's Hospital
        • Principal Investigator:
          • Robert Henderson
        • Contact:
      • Galway, Ireland
        • Recruiting
        • University Hospital Galway
        • Contact:
        • Principal Investigator:
          • Amjad Hayat
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Recruiting
        • Amsterdam UMC - location VUMC
        • Contact:
          • Sanne Tonnio
        • Principal Investigator:
          • Sanne Tonnio
      • Delft, Netherlands
        • Recruiting
        • Reinier de Graafweg 3-11 - Postbus 5011 - 2625 AD Delft
        • Contact:
          • Posthuma Ward
        • Principal Investigator:
          • Posthuma Ward
      • Groningen, Netherlands
        • Recruiting
        • Universitair Medisch Centrum Groningen
        • Contact:
        • Principal Investigator:
          • Wouter Plattel
      • Nijmegen, Netherlands
      • The Hague, Netherlands
        • Recruiting
        • NL 331 - Haaglanden Medisch Centrum (HMC) - Haaglanden MC
        • Contact:
        • Principal Investigator:
          • Liane Te Boome
  • New Zealand
      • Auckland, New Zealand, 1023
        • Recruiting
        • Auckland City Hospital
        • Contact:
          • Leanne Berkahn
        • Principal Investigator:
          • Leanne Berkahn
  • Portugal
      • Lisbon, Portugal
        • Recruiting
        • Instituto Portugues de Oncologia de Lisboa Francisco Gentil
        • Contact:
        • Principal Investigator:
          • Susana Carvalho
  • Slovakia
      • Bratislava, Slovakia
        • Recruiting
        • Narodny Onkologicky Ustav
        • Contact:
        • Principal Investigator:
          • Andrej Vranovsky
  • Spain
      • Barcelona, Spain, ES 08908
        • Recruiting
        • Institut Catala d'Oncologia
        • Contact:
          • Sureda-Balari Anna
        • Principal Investigator:
          • Sureda-Balari Anna
      • Barcelona, Spain, ES 08003
        • Recruiting
        • Hospital del Mar
        • Principal Investigator:
          • Blanca Sanchez Gonzalez
        • Contact:
      • Pamplona, Spain
        • Recruiting
        • Complejo Hospitalario de Navarra
        • Contact:
        • Principal Investigator:
          • Jose Arguinano
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Recruiting
        • Aberdeen Royal Infirmary
        • Contact:
          • Dominic Culligan
        • Principal Investigator:
          • Dominic Culligan
      • Birmingham, United Kingdom, B15 2GW
        • Recruiting
        • University Hospitals Birmingham
        • Principal Investigator:
          • Lindsay George
        • Contact:
      • Bodelwyddan, United Kingdom, LL18 5UJ
      • Bristol, United Kingdom
        • Recruiting
        • Bristol Haematology and Oncology Centre
        • Contact:
          • Claire Burney
        • Principal Investigator:
          • Claire Burney
      • Colchester, United Kingdom, CO4 5JL
      • Coventry, United Kingdom, CV2 2DX
        • Recruiting
        • University Hospital Coventry
        • Contact:
        • Principal Investigator:
          • Duncan Murray
      • Glasgow, United Kingdom, G12 0YN
        • Recruiting
        • Beatson West of Scotland Cancer Centre
        • Contact:
          • Pam McKay
        • Principal Investigator:
          • Pam McKay
      • Hull, United Kingdom, HU16 5JQ
        • Recruiting
        • Castle Hill Hospital
        • Contact:
          • Russell Patmore
        • Principal Investigator:
          • Russell Patmore
      • Leeds, United Kingdom, LS9 7TF
        • Recruiting
        • St James University Hospital
        • Contact:
        • Principal Investigator:
          • Catherine Burton
      • Leicester, United Kingdom, LE1 5WW
        • Recruiting
        • University Hospitals of Leicester NHS Trust
        • Contact:
          • Sapna Ladani
        • Principal Investigator:
          • Sapna Ladani
      • Liverpool, United Kingdom, L7 8YA
        • Recruiting
        • The Clatterbridge Cancer Centre NHSFT, 65 Pembroke Place
        • Contact:
          • Nagesh Kalakonda
        • Principal Investigator:
          • Nagesh Kalakonda
      • London, United Kingdom, EC1A 7BE
        • Recruiting
        • St Bartholomew's Hospital
        • Contact:
          • Rebecca Auer
        • Principal Investigator:
          • Rebecca Auer
      • London, United Kingdom, NW1 2BU
        • Recruiting
        • University College London Hospitals NHS Foundation Trust (UCLH)
        • Contact:
          • Maria Marzolini
        • Principal Investigator:
          • Maria Marzolini
      • London, United Kingdom, SW3 6JZ
        • Recruiting
        • Royal Marsden Hospital Chelsea
        • Principal Investigator:
          • Sunil Iyengar
        • Contact:
      • Manchester, United Kingdom, M20 4BX
      • Norwich, United Kingdom, NR4 7UY
        • Recruiting
        • Norfolk & Norwich University Hospital
        • Contact:
          • Nimish Shah
        • Principal Investigator:
          • Nimish Shah
      • Oxford, United Kingdom, OX3 7LE
        • Recruiting
        • Churchill Hospital
        • Contact:
          • Graham Collins
        • Principal Investigator:
          • Graham Collins
      • Plymouth, United Kingdom, PL6 8DH
        • Recruiting
        • Derriford Hospital
        • Contact:
          • Patrick Medd
        • Principal Investigator:
          • Patrick Medd
      • Sheffield, United Kingdom, S10 2JF
        • Recruiting
        • Royal Hallamshire Hospital
        • Principal Investigator:
          • Nick Morley
        • Contact:
      • Southampton, United Kingdom, SO16 6YD
        • Recruiting
        • Southampton General Hospital
        • Principal Investigator:
          • Andrew Davies
        • Contact:
      • Sunderland, United Kingdom, SR4 7TP
        • Recruiting
        • Sunderland Royal Hospital
        • Principal Investigator:
          • Scott Marshall
        • Contact:
      • Sutton, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden Hospital
        • Principal Investigator:
          • Sunil Iyengar
        • Contact:
      • Torquay, United Kingdom, TQ2 7AA
        • Recruiting
        • Torbay Hospital
        • Contact:
          • Deborah Turner
        • Principal Investigator:
          • Deborah Turner
      • Truro, United Kingdom, TR1 3LJ
        • Recruiting
        • Royal Cornwall Hospital
        • Principal Investigator:
          • Bryson Pottinger
        • Contact:
          • Bryson Pottinger
    • Cardiff
      • Cardiff, Cardiff, United Kingdom, CF14 4XW
        • Recruiting
        • University Hospital of Wales, Cardiff & Vale University Local Health Board
        • Contact:
          • Eve Gallop-Evans
        • Principal Investigator:
          • Eve Gallop-Evans
    • Lancashire
      • Blackpool, Lancashire, United Kingdom, FY3 8NR
        • Recruiting
        • Blackpool Victoria Hospital
        • Contact:
          • Mac Macheta
        • Principal Investigator:
          • Mac Macheta
    • Newcastle
      • Newcastle upon Tyne, Newcastle, United Kingdom, NE7 7DN
        • Recruiting
        • Freeman Hospital, Newcastle
        • Contact:
          • Wendy Osborne
        • Principal Investigator:
          • Wendy Osborne
    • Nottingham
      • Nottingham, Nottingham, United Kingdom, NG51PB
        • Recruiting
        • Nottingham University Hospitals NHST
        • Contact:
          • Emily Chernucha
        • Principal Investigator:
          • Emily Chernucha
    • Scotland
      • Glasgow, Scotland, United Kingdom, G71 8BB
        • Recruiting
        • Lanarkshire
        • Contact:
          • Charlotte Thomas
        • Principal Investigator:
          • Charlotte Thomas
    • Tooting
      • London, Tooting, United Kingdom, SW17 0QT
  • United States
    • California
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University - (Stanford Cancer Institute)
        • Principal Investigator:
          • Ranjana Advani
        • Contact:
          • Austin Yeung
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami School of Medicine
        • Contact:
          • Safia Sawleh
        • Principal Investigator:
          • Craig Moskowitz
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Principal Investigator:
          • Alison Moskowitz
        • Contact:
          • Pamela Park

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Males and females aged 16-69 years (inclusive) (age range is 18-69 in US and EU)
  • Histologically confirmed classical Hodgkin lymphoma
  • Stage I or II supradiaphragmatic disease with no mediastinal bulk disease (defined as greater than a third of the transthoracic diameter at any level of thoracic vertebra as determined by CT) or B symptoms. Bulky disease at other sites is acceptable. Extranodal disease (single extranodal site (stage I) or contiguous nodal extension (stage II)) is acceptable.
  • ECOG performance status 0-2.
  • No previous treatment for Hodgkin lymphoma
  • Fit to receive anthracycline-based chemotherapy (patients with a history of ischaemic heart disease or hypertension should have a left ventricular ejection fraction of ≥50%)
  • Creatinine clearance (measured or calculated >40ml/min
  • Total bilirubin <1.5 x upper limit of normal, unless attributable to disease or known Gilbert's syndrome
  • ALT or AST < 2 x upper limit of normal
  • Adequate bone marrow function with neutrophils ≥1.0x10^9/l and platelets ≥100x10^9/l
  • Haemoglobin ≥8g/dL
  • Willing and able to comply with the requirements of the protocol, including contraceptive advice, where applicable
  • Written informed consent

Exclusion Criteria:

  • Previous treatment for Hodgkin lymphoma, excluding short courses of oral corticosteroids at a dose of 100mg prednisolone (or equivalent) for up to 7 days
  • Infradiaphragmatic disease
  • Nodular lymphocyte predominant Hodgkin lymphoma
  • Absence of FDG-avid lesions on baseline PET scan
  • Age 70 years or over or age 15 years or under
  • Other cancer diagnosed with the last 5 years. Patients with completely excised carcinoma in situ of any type and basal or squamous cell carcinoma of the skin are not excluded
  • Recurrent or persistent other cancer within last 5 years irrespective of date of initial diagnosis
  • Pre-existing grade ≥1 sensory or motor neuropathy from any cause
  • History of or current progressive multi-focal leukoencephalopathy or other chronic condition of the brain
  • Symptomatic neurologic disease compromising normal activities of daily living or requiring medications
  • Infection with HIV, hepatitis C or active hepatitis B infection (surface antigen or DNA positive)
  • Any active systemic viral, bacterial or fungal infection requiring systemic antibiotics, antivirals or antifungals within 2 weeks prior to first trial drug dose
  • Receiving or recently treated with any other investigational agent (within 4 weeks of trial entry)
  • Pregnant or breastfeeding women
  • Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin or any component of ABVD
  • Known history of any cardiovascular or respiratory conditions that would preclude anthracycline or bleomycin administration
  • Other significant medical or psychiatric comorbidity that in the opinion of the investigator would make administration of ABVD or A2VD hazardous

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ABVD +/- ISRT

2 x 28 day cycles of ABVD: Doxorubicin 25mg/m^2 IV days 1 & 15 Bleomycin 10000 IU/m^2 days 1 & 15 Vinblastine 6mg/m^2 days 1 & 15 Dacarbazine 375mg/m^2 days 1 & 15

PET-CT after 2 cycles will determine subsequent treatment:

Deauville score 1-3 (PET CMR): 1 further cycle of ABVD then follow up Deauville score 4 (PET positive): 2 further cycles of ABVD followed by involved site radiotherapy (ISRT) Deauville score 5: withdraw from trial treatment; further treatment will be given at the treating clinician's discretion. Enter follow up for the trial.
Radiation: Involved site radiotherapy

Involved site radiotherapy as per International Lymphoma Radiation Oncology Group (ILROG) guidelines.

Recommended dose 30Gy

Drug: Doxorubicin
See arm description
Drug: Bleomycin
See arm description
Drug: Vinblastine
See arm description
Drug: Dacarbazine
See arm description
Experimental: A2VD +/- ISRT

2 x 28 day cycles of A2VD: Doxorubicin 25mg/m^2 IV days 1 & 15 Brentuximab vedotin 1.2mg/kg (max 120mg) days 1 & 15 Vinblastine 6mg/m^2 days 1 & 15 Dacarbazine 375mg/m^2 days 1 & 15 Filgrastim (or equivalent haematopoietic growth factor) for 5-7 days from day 2 and day 16 (or single dose of peg-filgrastim on days 2 & 16)

PET-CT after 2 cycles will determine subsequent treatment:

Deauville score 1-3 (PET CMR): 1 further cycle of A2VD then follow up Deauville score 4 (PET positive): 2 further cycles of A2VD followed by involved site radiotherapy (ISRT) Deauville score 5: withdraw from trial treatment; further treatment will be given at the treating clinician's discretion. Enter follow up for the trial.
Radiation: Involved site radiotherapy

Involved site radiotherapy as per International Lymphoma Radiation Oncology Group (ILROG) guidelines.

Recommended dose 30Gy

Drug: Doxorubicin
See arm description
Drug: Vinblastine
See arm description
Drug: Dacarbazine
See arm description
Drug: Brentuximab vedotin
See arm description
Drug: Haematopoietic growth factor
See arm description
Other Names:
  • Filgrastim
  • G-CSF
  • Pegfilgrastim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: 3 years from end of treatment
Time from randomisation to first date of progression or death
3 years from end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PET-CMR (complete metabolic response) rate
Time Frame: At the end of cycle 2 (each cycle is 28 days)
Proportion of patients who have Deauville score 1-3 on PET-CT scan
At the end of cycle 2 (each cycle is 28 days)
Event-free survival (EFS)
Time Frame: 5 years from end of treatment
Time from randomisation to first date of progression, death or a positive PET2 scan (whichever occurs first)
5 years from end of treatment
Overall survival (OS)
Time Frame: 5 years from end of treatment
Time from randomisation to death
5 years from end of treatment
Incidence of second cancers and cardiovascular disease
Time Frame: 5 years from end of treatment
Proportion in each arm who develop a second cancer or cardiovascular disease
5 years from end of treatment
Safety and toxicity of ABVD and A2VD as described by CTCAE v5.0
Time Frame: From start of treatment to 30 days post treatment
Numbers of patients experiencing a grade 3+ adverse event of each type will be presented and compared between the arms. Only patients who start treatment will be included
From start of treatment to 30 days post treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic power of PET after 1 and 2 cycles of ABVD/A2VD
Time Frame: Up to 5 years after end of treatment
7A Associations between PET1 Deauville score (DS) and PET2 DS; 7B Associations between PET1 DS and EFS; 7C Associations between PET1 DS and OS; 7D Associations between PET1 DS and PFS; 7E Associations between PET2 DS and EFS; 7F Associations between PET2 DS and OS; 7G Associations between PET2 DS and PFS; 7H Associations between EORTC baseline stratification and PET1 DS; 7I Associations between EORTC baseline stratification and PET2 DS; 7J Associations between EORTC baseline stratification and EFS; 7K Associations between EORTC baseline stratification and OS; 7L Associations between EORTC baseline stratification and EFS; 7M Associations between GHSG baseline stratification and PET1 DS; 7N Associations between GHSG baseline stratification and PET2 DS; 7O Associations between GHSG baseline stratification and EFS; 7P Associations between GHSG baseline stratification and OS; 7Q Associations between GHSG baseline stratification and EFS
Up to 5 years after end of treatment
Prognostic and predictive power of baseline PET features
Time Frame: Up to 3 years after end of treatment
The association of baseline quantitative PET parameters such as total lesion glycolysis (TLG) and PFS/EFS/OS will be assessed. The ability to predict PET score (PET1 and PET2) and Hodgkin lymphoma events within 3 years will be compared: 8A Associations between baseline quantitative PET parameters such as total lesion glycolysis (TLG) and PFS; 8B Associations between baseline quantitative PET parameters such as total lesion glycolysis (TLG) and OS; 8C Associations between baseline quantitative PET parameters such as total lesion glycolysis (TLG) and EFS; 8D Associations between baseline quantitative PET parameters such as total lesion glycolysis (TLG) and PET1 DS; 8E Associations between baseline quantitative PET parameters such as total lesion glycolysis (TLG) and PET2 DS
Up to 3 years after end of treatment
Change in pulmonary function tests at end of treatment, 1 and 2 years
Time Frame: 3 months & 1 year after end of treatment
Change from baseline pulmonary function test (DLCO/TLCO percentage of normal) will be compared
3 months & 1 year after end of treatment
Correlation between maximum tumour dimension at baseline and end of treatment with PFS
Time Frame: Up to 5 years after end of treatment
The relationship between maximum tumour dimension at baseline and at end of treatment and PFS will be examined. This may also be analysed within the groups that achieve/do not achieve CMR after 2 cycles and may also be adjusted for the use of consolidation radiotherapy
Up to 5 years after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

University of Miami
Takeda
European Organisation for Research and Treatment of Cancer - EORTC
Canadian Cancer Trials Group
Seagen Inc.
Australasian Leukaemia and Lymphoma Group

Investigators

  • Principal Investigator: John Radford, University of Manchester / Christie Hospital, Manchester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2022

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

September 1, 2032

Study Registration Dates

First Submitted

November 27, 2020

First Submitted That Met QC Criteria

December 21, 2020

First Posted (Actual)

December 28, 2020

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RADAR
  • UCL/15/0105 (Other Identifier: UCL)
  • 2020-005160-65 (EudraCT Number)
  • IISR X25041 (Other Grant/Funding Number: Takeda Pharmaceutical Company Ltd)
  • CCTG HD.12 (Other Identifier: CCTG)
  • IRB number 20230081 (Other Identifier: University of Miami)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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