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Recruiting NCT06667908

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

Phase II Interventional Carcinoma, Non-Small-Cell Lung

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JNJ-90301900, Durvalumab, Concurrent Chemo/Radiation Therapy (cCRT), Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin.
Who it may be relevant to
Registry conditions: Carcinoma, Non-Small-Cell Lung. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Brazil, China, France +5
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 2, Randomized, Open-Label, Active-Controlled Study of JNJ-90301900 in Combination With Chemoradiation Followed by Durvalumab in Locally Advanced and Unresectable Stage III NSCLC

Overview

The purpose of this study is to determine whether JNJ-90301900 added to concurrent platinum-based doublet chemotherapy with radiation therapy (cCRT) followed by consolidation immunotherapy (cIT) can improve objective response rate (ORR; that is percentage of participants whose best response is complete response or partial response during the study) in participants with locally advanced and unresectable stage III non-small cell lung cancer.

Interventions

  • Drug JNJ-90301900
    JNJ-90301900 will be injected intratumorally and/or intranodally.
  • Biological Durvalumab
    Durvalumab will be administered as intravenous (IV) infusion as cIT.
  • Radiation Concurrent Chemo/Radiation Therapy (cCRT)
    Radiation by intensity modulated radiation therapy (IMRT) will be administered.
  • Drug Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin
    Carboplatin will be administered as IV infusion as platinum-based doublet chemotherapy.
  • Drug Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel
    Paclitaxel will be administered as IV infusion as platinum-based doublet chemotherapy.

Primary outcome measures

  • Objective Response Rate (ORR) Using Independent Central Review (ICR) Assessment [Time frame: Up to 2 Years and 2 months]
Secondary outcome measures (9)
  • Objective Response Rate (ORR) Post-cCRT and Pre-cIT [Time frame: Up to 12 Weeks]
  • Disease Control Rate (DCR) Post-cCRT and Pre-cIT [Time frame: Up to 12 Weeks]
  • Objective Response Rate (ORR) as Assessed by the Investigator [Time frame: Up to 2 Years and 2 months]
  • Progression Free Survival (PFS) [Time frame: Up to 2 Years and 2 months]
  • Duration of Response (DoR) [Time frame: Up to 2 Years and 2 months]
  • Time to Locoregional Failure (LRF) [Time frame: Up to 2 Years and 2 months]
  • Time to Distant Failure (DF) [Time frame: Up to 2 Years and 2 months]
  • Number of Participants with Treatment-Emergent Adverse Event (TEAE) Related to Study Treatment [Time frame: Up to 2 Years and 2 months]
  • Number of Participants Reporting Laboratory Parameters, Physical Examination, Vital Signs Including Eastern Cooperative Oncology Group (ECOG) Performance Status Abnormalities [Time frame: Up to 2 Years and 2 months]

Eligibility criteria

Inclusion criteria

  • Must be a candidate for standard of care (SOC) treatment of non small cell lung cancer (NSCLC) by concurrent platinum-based doublet chemotherapy with radiation therapy (cCRT) followed by consolidation durvalumab treatment as determined by the investigator and per local guidelines at screening
  • Have a medical history of pathologically (histologically or cytologically) proven diagnosis of NSCLC within 3 months prior to enrollment/randomization
  • Have locally advanced unresectable stage III NSCLC according to the eighth edition lung cancer stage classification
  • Have at least 1 target lesion (primary lung lesion or involved lymph node\[s\]) per RECIST version 1.1 that is amenable to intratumoral and/or intranodal injection and intensity modulated radiation therapy (IMRT) as determined by the investigator at screening
  • Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1

Exclusion criteria

  • Medical history of: (a) Primary immunodeficiency (b) Organ transplant that requires therapeutic immunosuppression
  • Any of the following within 3 months prior to enrollment/randomization: severe or unstable angina, myocardial infarction, clinically significant ventricular arrhythmias or heart failure New York heart association functional classification class III to IV
  • Another concurrent or prior primary malignancy within the last 36 months at informed consent
  • Known allergies, hypersensitivity, or intolerance to any ingredients of JNJ-90301900 crystalline solution, platinum-based doublet chemotherapy (ChT), or durvalumab
  • History of coagulation disorders, including: (a) Active bleeding diathesis or requirement for therapeutic anticoagulation or antiplatelet that cannot be interrupted or altered for JNJ-90301900 injection procedures, (b) Major thromboembolic events (for example, pulmonary embolism, cerebrovascular accident) within 3 months of enrollment or randomization

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 18 centers
  • Moores Cancer Center at UC San Diego Health — La Jolla
  • University of Connecticut Health Center — Farmington
  • Yale University — New Haven
  • University of Miami — Miami
  • Orlando Health Cancer Institute — Orlando
  • Emory University Winship Cancer Institute — Atlanta
  • Beth Israel Deaconess Medical Center — Boston
  • Washington University in St Louis — St Louis
  • … and 10 more centers
France · 5 centers
  • Hopital De La Cavale Blanche — Brest
  • Hopital Nord Marseille — Marseille
  • Hopital Tenon — Paris
  • Institut Curie — Paris
  • Gustave Roussy — Villejuif
Australia · 4 centers
  • Royal Brisbane and Women's Hospital — Herston
  • Sir Charles Gairdner Hospital — Nedlands
  • Macquarie University — North Ryde
  • Royal Melbourne Hospital — Parkville
Spain · 4 centers
  • Hosp. Univ. 12 de Octubre — Madrid
  • Clinica Univ. de Navarra — Pamplona
  • Hosp. Clinico Univ. de Santiago — Santiago de Compostela
  • Hosp. Univ. I Politecni La Fe — Valencia
Brazil · 3 centers
  • Fundacao Pio XII — Barretos
  • Sociedade Beneficente de Senhoras Hospital Sirio Libanes — São Paulo
  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein — São Paulo
China · 3 centers
  • Dongguan People s Hospital — Dongguan
  • The First Affiliated Hospital Sun Yat sen University — Guangzhou
  • The Affiliated Cancer Hospital of Shandong First Medical University — Jinan
Netherlands · 2 centers
  • Antoni van Leeuwenhoek — Amsterdam
  • Radboud Umcn — Nijmegen
Turkey (Türkiye) · 2 centers
  • Marmara University Pendik Training Hospital — Istanbul
  • Sakarya University Training and Research Hospital — Sakarya
Hong Kong · 1 center
  • Prince of Wales Hospital — Shatin
United Kingdom · 1 center
  • University College London Hospitals — London

Identifiers

NCT: NCT06667908 · 90301900NSC2001 · 90301900NSC2001 · 2024-518276-32-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗