Clinical trial • Phase II • Oncology

Hafnium oxide for Non-small cell lung cancer (stage III, locally advanced, unresectable)

Phase II trial of Hafnium oxide for Non-small cell lung cancer (stage III, locally advanced, unresectable).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer (stage III, locally advanced, unresectable)
Trial Stage
Phase II
Drug Modality
Other

Key dates

Initial CTIS Submission Date
31-10-2024
First CTIS Authorization Date
10-03-2025

Trial design

Randomised, open-label, standard of care chemoradiation (concurrent chemoradiation, ccrt) followed by consolidation durvalumab-controlled Phase II trial across 12 sites in Netherlands, Spain, France.

Randomised
Yes
Open Label
Yes
Comparator
Standard of care chemoradiation (concurrent chemoradiation, cCRT) followed by consolidation durvalumab
Target Sample Size
105

Eligibility

Recruits 105 adults.

Inclusion criteria

  • {"criterion_text":"- Have locally advanced and unresectable stage III lung cancer"}
  • {"criterion_text":"- Pathologically (histologically or cytologically) proven diagnosis of NSCLC within 3 months prior to enrollment/randomization. Pathologic mediastinal staging with mediastinoscopy, mediastinotomy, EBUS, EUS, and/or CT guided biopsy is required when deemed technically feasible and clinically appropriate."}
  • {"criterion_text":"- A candidate for standard of care treatment of study cancer by cCRT followed by consolidation durvalumab treatment"}
  • {"criterion_text":"- Have at least one target lesion (primary lung lesion or involved lymph nodes) planned to receive the full dose of prescribed RT [60 Gy]) per RECIST 1.1 that is amenable to intratumoral or intranodal injection and external-beam irradiation and IMRT as determined by the investigator at screening."}
  • {"criterion_text":"- Have documented tumor proportion score (TPS) of PD-L1 by local or central lab"}
  • {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1"}
  • {"criterion_text":"- Life expectancy ≥6 months at Consent"}

Exclusion criteria

  • {"criterion_text":"- Have mixed small cell and non-small cell lung cancer histology"}
  • {"criterion_text":"- Prior systemic ChT for lung cancer within the prior 36 months at informed consent"}
  • {"criterion_text":"- Participant received prior intrathoracic RT that would overlap with the current study PTV for lung cancer, or recommended normal tissue constraints are exceeded when creating a summation of the prior and current radiation plans. Prior RT is allowable only if the treatment is >36 months at informed consent and does not interfere with the study lesion assessment; RT to chest wall, such as for early-stage breast cancer or skin cancer, is allowable"}
  • {"criterion_text":"- Contraindications to the use of JNJ-90301900 per the IB or platinum-based doublet ChT or durvalumab per local prescribing information"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- ORR using Independent Central Review (ICR) assessments according to RECIST v1.1 (best response)","definition_or_measurement_approach":"Assessment by Independent Central Review (ICR) according to RECIST v1.1; best response"}

Recruitment

Planned Sample Size
105
Recruitment Window Months
44
Consent Approach
Informed consent obtained from adult participants. Subject information and informed consent forms (SIS and ICF) are provided (document titles indicate availability in English, Dutch, Spanish and French). No detailed information on assent or parental consent processes is provided in the available data.

Geography

Total Number Of Sites
12
Total Number Of Participants
25

Netherlands

Earliest CTIS Part Ii Submission Date
28-02-2025
Latest Decision Or Authorization Date
13-11-2025
Processing Time Days
258
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Radboud universitair medisch centrum Stichting
Department Name
Research Unit Longziekten
Contact Person Name
Olga Schuurbiers
Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
long departement
Contact Person Name
Joop de Langen
Contact Person Email
j.d.langen@nki.nl

Spain

Earliest CTIS Part Ii Submission Date
27-01-2025
Latest Decision Or Authorization Date
18-11-2025
Processing Time Days
295
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Oncology
Contact Person Name
Francisco de Asís Aparisi Aparisi Vidal
Contact Person Email
francisco_aparisi@iislafe.es
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Oncology
Contact Person Name
Patricia Calvo
Site Name
Clinica Universidad De Navarra
Department Name
Oncology
Contact Person Name
Maria Esperanza Rodríguez
Contact Person Email
mrruiz@unav.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Contact Person Name
Luis Paz-Ares
Contact Person Email
lpazaresr@seom.org

France

Earliest CTIS Part Ii Submission Date
27-01-2025
Latest Decision Or Authorization Date
17-11-2025
Processing Time Days
294
Number Of Sites
6
Number Of Participants
10

Sites

Site Name
Institut Gustave Roussy
Department Name
Radiation Oncology
Contact Person Name
Antonin Levy
Contact Person Email
antoine.levu@gustaveroussy.fr
Site Name
Institut Curie
Department Name
Pneumology
Contact Person Name
Nicolas Girard
Contact Person Email
nicolas.girard2@curie.fr
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
Pneumology
Contact Person Name
Florian Guisier
Contact Person Email
florian.guisier@chu-rouen.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Oncology
Contact Person Name
Renaud Descourt
Contact Person Email
renaud.descourt@chu-brest.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Oncology
Contact Person Name
Pascale Tomasini
Contact Person Email
pascale.tomasini@ap-hm.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Chest Department
Contact Person Name
Jacques Cadranel
Contact Person Email
jacques.cadranel@aphp.fr

Sponsor

Primary sponsor

Full Name
Johnson & Johnson Enterprise Innovation Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Medidata Solutions Inc.
Name
4g Clinical LLC

Third parties

  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Imaging","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
JNJ-90301900
Active Substance
Hafnium oxide
Modality
Other
Routes Of Administration
Intratumoral use
Route
Intratumoral
Combination Treatment
Yes

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