Uno studio su JNJ-90301900 in combinazione con chemioradioterapia seguita da immunoterapia di consolidamento per il cancro polmonare non a piccole cellule (NSCLC) (CONVERGE)
Uno studio di fase 2, randomizzato, in aperto, con controllo attivo su JNJ-90301900 in combinazione con chemioradioterapia seguito da Durvalumab nel NSCLC in stadio III localmente avanzato e non resecabile
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.
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Fase 2
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Study Contact
- Numero di telefono: 844-434-4210
- Email: Participate-In-This-Study1@its.jnj.com
Luoghi di studio
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Camperdown, Australia, 2050
- Reclutamento
- Chris O'Brien Lifehouse
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Herston, Australia, 4029
- Reclutamento
- Royal Brisbane and Women's Hospital
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Nedlands, Australia, 6009
- Reclutamento
- Sir Charles Gairdner Hospital
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North Ryde, Australia, 2109
- Reclutamento
- Macquarie University
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Parkville, Australia, 3050
- Reclutamento
- Royal Melbourne Hospital
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Barretos, Brasile, 14784 400
- Reclutamento
- Fundacao Pio XII
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São Paulo, Brasile, 05651 901
- Reclutamento
- Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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São Paulo, Brasile, 01308 050
- Reclutamento
- Sociedade Beneficente de Senhoras Hospital Sirio Libanes
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Dongguan, Cina, 523109
- Reclutamento
- Dongguan People s Hospital
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Guangzhou, Cina, 510080
- Reclutamento
- The First Affiliated Hospital Sun Yat sen University
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Jinan, Cina, 250117
- Reclutamento
- The Affiliated Cancer Hospital of Shandong First Medical University
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Brest, Francia, 29200
- Reclutamento
- Hopital De La Cavale Blanche
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Marseille, Francia, 13015
- Reclutamento
- Hopital Nord Marseille
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Paris, Francia, 75248
- Reclutamento
- Institut Curie
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Paris, Francia, 75020
- Reclutamento
- Hopital Tenon
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Rouen, Francia, 76000
- Reclutamento
- CHU Rouen Hopital Charles Nicolle
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Villejuif, Francia, 94805
- Reclutamento
- Gustave Roussy
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Shatin, Hong Kong
- Reclutamento
- Prince of Wales Hospital
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Amsterdam, Olanda, 1066 CX
- Reclutamento
- Antoni van Leeuwenhoek
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Nijmegen, Olanda, 6525 GA
- Reclutamento
- Radboud Umcn
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London, Regno Unito, NW1 2BU
- Reclutamento
- University College London Hospitals
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Madrid, Spagna, 28041
- Reclutamento
- Hosp. Univ. 12 de Octubre
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Pamplona, Spagna, 31008
- Reclutamento
- Clinica Univ. de Navarra
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Santiago de Compostela, Spagna, 15706
- Reclutamento
- Hosp. Clinico Univ. de Santiago
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Valencia, Spagna, 46026
- Reclutamento
- Hosp. Univ. I Politecni La Fe
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California
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La Jolla, California, Stati Uniti, 92037
- Reclutamento
- Moores Cancer Center at UC San Diego Health
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Connecticut
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Farmington, Connecticut, Stati Uniti, 06030
- Completato
- University of Connecticut Health Center
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New Haven, Connecticut, Stati Uniti, 06519
- Reclutamento
- Yale University
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Florida
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Miami, Florida, Stati Uniti, 33136
- Reclutamento
- University of Miami
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Orlando, Florida, Stati Uniti, 32806
- Reclutamento
- Orlando Health Cancer Institute
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Georgia
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Atlanta, Georgia, Stati Uniti, 30306
- Reclutamento
- Emory University Winship Cancer Institute
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02215
- Reclutamento
- Beth Israel Deaconess Medical Center
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Missouri
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St Louis, Missouri, Stati Uniti, 63130
- Reclutamento
- Washington University in St Louis
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New Jersey
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New Brunswick, New Jersey, Stati Uniti, 08901
- Reclutamento
- Rutgers Cancer Institute of New Jersey
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New York
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New York, New York, Stati Uniti, 10016
- Reclutamento
- NYU Langone Health
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New York, New York, Stati Uniti, 10065
- Reclutamento
- Memorial Sloan Kettering Cancer Center
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North Carolina
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Chapel Hill, North Carolina, Stati Uniti, 27514
- Reclutamento
- University of North Carolina at Chapel Hill
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Pinehurst, North Carolina, Stati Uniti, 28374
- Reclutamento
- FirstHealth of the Carolinas
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Ohio
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Cleveland, Ohio, Stati Uniti, 44106
- Reclutamento
- University Hospitals Cleveland Medical Center
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Oregon
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Portland, Oregon, Stati Uniti, 97239
- Reclutamento
- Oregon Health And Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19104
- Reclutamento
- University of Pennsylvania
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Texas
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Houston, Texas, Stati Uniti, 77030
- Reclutamento
- MD Anderson Cancer Center
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Vermont
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Burlington, Vermont, Stati Uniti, 05401
- Reclutamento
- University of Vermont Medical Center
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Istanbul, Turchia (Türkiye), 34899
- Reclutamento
- Marmara University Pendik Training Hospital
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Sakarya, Turchia (Türkiye), 54100
- Reclutamento
- Sakarya University Training and Research Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
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Sperimentale: Part 1: Cohort A and Cohort B
Participants will receive JNJ-90301900 injected intratumorally and/or intranodally (cohort A: 22% gross tumor volume [GTV] and cohort B: 33% GTV) along with cCRT (concurrent chemotherapy with radiation therapy) followed by consolidation immunotherapy (cIT) to evaluate feasibility of JNJ-90301900 injection procedure. |
JNJ-90301900 will be injected intratumorally and/or intranodally. Durvalumab will be administered as intravenous (IV) infusion as cIT. Radiation by intensity modulated radiation therapy (IMRT) will be administered. Carboplatin will be administered as IV infusion as platinum-based doublet chemotherapy. Paclitaxel will be administered as IV infusion as platinum-based doublet chemotherapy. |
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Sperimentale: Part 2: Arm A and Arm B
Participants will receive JNJ-90301900 injected intratumorally and/or intranodally (Arm A: 22% GTV and Arm B: 33% GTV) along with cCRT followed by cIT to evaluate the efficacy and safety of JNJ-90301900. |
JNJ-90301900 will be injected intratumorally and/or intranodally. Durvalumab will be administered as intravenous (IV) infusion as cIT. Radiation by intensity modulated radiation therapy (IMRT) will be administered. Carboplatin will be administered as IV infusion as platinum-based doublet chemotherapy. Paclitaxel will be administered as IV infusion as platinum-based doublet chemotherapy. |
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Comparatore attivo: Part 2: Arm C: (Control treatment)
Participants will receive treatment with cCRT followed by cIT as control treatment to evaluate the efficacy and safety of JNJ-90301900. |
Durvalumab will be administered as intravenous (IV) infusion as cIT. Radiation by intensity modulated radiation therapy (IMRT) will be administered. Carboplatin will be administered as IV infusion as platinum-based doublet chemotherapy. Paclitaxel will be administered as IV infusion as platinum-based doublet chemotherapy. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Objective Response Rate (ORR) Using Independent Central Review (ICR) Assessment
Lasso di tempo: Up to 2 Years and 2 months
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ORR is defined as the percentage of participants who have a best response of complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1 using ICR assessments. |
Up to 2 Years and 2 months
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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Objective Response Rate (ORR) Post-cCRT and Pre-cIT
Lasso di tempo: Up to 12 Weeks
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Objective response rate is defined as percentage of participants who achieve CR or PR, post-concurrent platinum-based doublet chemotherapy with radiation therapy (cCRT) and pre-consolidation immunotherapy (cIT) based on investigator's assessment according to RECIST v1.1. |
Up to 12 Weeks
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Disease Control Rate (DCR) Post-cCRT and Pre-cIT
Lasso di tempo: Up to 12 Weeks
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DCR is defined as percentage of participants who achieve CR, PR and stable disease post-cCRT and pre-cIT based on investigator's assessment according to RECIST v1.1. |
Up to 12 Weeks
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Objective Response Rate (ORR) as Assessed by the Investigator
Lasso di tempo: Up to 2 Years and 2 months
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ORR is defined as the percentage of participants who have a best response of CR or PR using RECIST v1.1 as assessed by the investigator. |
Up to 2 Years and 2 months
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Progression Free Survival (PFS)
Lasso di tempo: Up to 2 Years and 2 months
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PFS is defined as the time from the enrollment/randomization until disease progression or death due to any cause according to RECIST v1.1. |
Up to 2 Years and 2 months
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Duration of Response (DoR)
Lasso di tempo: Up to 2 Years and 2 months
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DoR will be calculated among responders from the date of initial documentation of a response to the date of first documented evidence of relapse according to RECIST v1.1, or death due to any cause, whichever occurs first. |
Up to 2 Years and 2 months
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Time to Locoregional Failure (LRF)
Lasso di tempo: Up to 2 Years and 2 months
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Time to LRF is defined as the time from enrollment/randomization to the first LRF using ICR assessments. |
Up to 2 Years and 2 months
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Time to Distant Failure (DF)
Lasso di tempo: Up to 2 Years and 2 months
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Time to DF is defined as the time from enrollment/randomization to the first DF using ICR assessments. |
Up to 2 Years and 2 months
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Number of Participants with Treatment-Emergent Adverse Event (TEAE) Related to Study Treatment
Lasso di tempo: Up to 2 Years and 2 months
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TEAE is defined as any new or worsening adverse event (AE) occurring at or after the initial administration of study treatment through the day of last dose of study treatment received plus 30 days or prior to the start of subsequent anticancer therapy (non-durvalumab), whichever is earlier, or any follow-up AE with onset date and time beyond 30 days after the last dose of study treatment but prior to the start of subsequent anticancer therapy, or any AE that is considered treatment-related regardless of the start date of the event. TEAEs related to JNJ-90301900 injection procedure, JNJ-90301900, RT, ChT, or cIT will be reported. |
Up to 2 Years and 2 months
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Number of Participants Reporting Laboratory Parameters, Physical Examination, Vital Signs Including Eastern Cooperative Oncology Group (ECOG) Performance Status Abnormalities
Lasso di tempo: Up to 2 Years and 2 months
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Participants with laboratory parameters, physical examination, vital signs including ECOG performance status abnormalities will be reported. |
Up to 2 Years and 2 months
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Collaboratori e investigatori
Sponsor
Sponsor
Investigatori
Investigatori
- Direttore dello studio: Johnson & Johnson Enterprise Innovation Inc. Clinical Trial, Johnson & Johnson Enterprise Innovation Inc.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- 90301900NSC2001
- 90301900NSC2001 (Altro identificatore: Janssen Research & Development, LLC)
- 2024-518276-32-00 (Identificatore di registro: EUCT number)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
Informazioni su farmaci e dispositivi, documenti di studio
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