Tutkimus JNJ-90301900:sta yhdessä kemosäteilyn kanssa, jota seuraa ei-pienisoluisen keuhkosyövän (NSCLC) vahvistava immunoterapia (CONVERGE)
Vaihe 2, satunnaistettu, avoin, aktiivisesti kontrolloitu tutkimus JNJ-90301900:sta yhdessä kemosäteilyn kanssa, jota seurasi Durvalumab paikallisesti edistyneessä ja leikkauttamattomassa vaiheen III NSCLC:ssä
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.
Tutkimuksen yleiskatsaus
Tila
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Study Contact
- Puhelinnumero: 844-434-4210
- Sähköposti: Participate-In-This-Study1@its.jnj.com
Opiskelupaikat
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Amsterdam, Alankomaat, 1066 CX
- Rekrytointi
- Antoni van Leeuwenhoek
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Nijmegen, Alankomaat, 6525 GA
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- Radboud Umcn
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Camperdown, Australia, 2050
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- Chris O'Brien Lifehouse
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Herston, Australia, 4029
- Rekrytointi
- Royal Brisbane and Women's Hospital
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Nedlands, Australia, 6009
- Rekrytointi
- Sir Charles Gairdner Hospital
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North Ryde, Australia, 2109
- Rekrytointi
- Macquarie University
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Parkville, Australia, 3050
- Rekrytointi
- Royal Melbourne Hospital
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Barretos, Brasilia, 14784 400
- Rekrytointi
- Fundacao Pio XII
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São Paulo, Brasilia, 05651 901
- Rekrytointi
- Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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São Paulo, Brasilia, 01308 050
- Rekrytointi
- Sociedade Beneficente de Senhoras Hospital Sirio Libanes
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Madrid, Espanja, 28041
- Rekrytointi
- Hosp. Univ. 12 de Octubre
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Pamplona, Espanja, 31008
- Rekrytointi
- Clinica Univ. de Navarra
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Santiago de Compostela, Espanja, 15706
- Rekrytointi
- Hosp. Clinico Univ. de Santiago
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Valencia, Espanja, 46026
- Rekrytointi
- Hosp. Univ. I Politecni La Fe
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Shatin, Hong Kong
- Rekrytointi
- Prince of Wales Hospital
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Dongguan, Kiina, 523109
- Rekrytointi
- Dongguan People s Hospital
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Guangzhou, Kiina, 510080
- Rekrytointi
- The First Affiliated Hospital Sun Yat sen University
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Jinan, Kiina, 250117
- Rekrytointi
- The Affiliated Cancer Hospital of Shandong First Medical University
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Brest, Ranska, 29200
- Rekrytointi
- Hopital De La Cavale Blanche
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Marseille, Ranska, 13015
- Rekrytointi
- Hopital Nord Marseille
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Paris, Ranska, 75248
- Rekrytointi
- Institut Curie
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Paris, Ranska, 75020
- Rekrytointi
- Hopital Tenon
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Rouen, Ranska, 76000
- Rekrytointi
- CHU Rouen Hopital Charles Nicolle
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Villejuif, Ranska, 94805
- Rekrytointi
- Gustave Roussy
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Istanbul, Turkki (Türkiye), 34899
- Rekrytointi
- Marmara University Pendik Training Hospital
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Sakarya, Turkki (Türkiye), 54100
- Rekrytointi
- Sakarya University Training and Research Hospital
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London, Yhdistynyt kuningaskunta, NW1 2BU
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- University College London Hospitals
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California
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La Jolla, California, Yhdysvallat, 92037
- Rekrytointi
- Moores Cancer Center at UC San Diego Health
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Connecticut
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Farmington, Connecticut, Yhdysvallat, 06030
- Valmis
- University of Connecticut Health Center
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New Haven, Connecticut, Yhdysvallat, 06519
- Rekrytointi
- Yale University
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Florida
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Miami, Florida, Yhdysvallat, 33136
- Rekrytointi
- University of Miami
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Orlando, Florida, Yhdysvallat, 32806
- Rekrytointi
- Orlando Health Cancer Institute
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Georgia
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Atlanta, Georgia, Yhdysvallat, 30306
- Rekrytointi
- Emory University Winship Cancer Institute
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Massachusetts
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Boston, Massachusetts, Yhdysvallat, 02215
- Rekrytointi
- Beth Israel Deaconess Medical Center
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Missouri
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St Louis, Missouri, Yhdysvallat, 63130
- Rekrytointi
- Washington University in St Louis
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New Jersey
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New Brunswick, New Jersey, Yhdysvallat, 08901
- Rekrytointi
- Rutgers Cancer Institute of New Jersey
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New York
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New York, New York, Yhdysvallat, 10016
- Rekrytointi
- NYU Langone Health
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New York, New York, Yhdysvallat, 10065
- Rekrytointi
- Memorial Sloan Kettering Cancer Center
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North Carolina
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Chapel Hill, North Carolina, Yhdysvallat, 27514
- Rekrytointi
- University of North Carolina at Chapel Hill
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Pinehurst, North Carolina, Yhdysvallat, 28374
- Rekrytointi
- FirstHealth of the Carolinas
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Ohio
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Cleveland, Ohio, Yhdysvallat, 44106
- Rekrytointi
- University Hospitals Cleveland Medical Center
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Oregon
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Portland, Oregon, Yhdysvallat, 97239
- Rekrytointi
- Oregon Health And Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Yhdysvallat, 19104
- Rekrytointi
- University of Pennsylvania
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Texas
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Houston, Texas, Yhdysvallat, 77030
- Rekrytointi
- MD Anderson Cancer Center
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Vermont
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Burlington, Vermont, Yhdysvallat, 05401
- Rekrytointi
- University of Vermont Medical Center
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 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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Kokeellinen: 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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Active Comparator: 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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Objective Response Rate (ORR) Using Independent Central Review (ICR) Assessment
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Objective Response Rate (ORR) Post-cCRT and Pre-cIT
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Tutkijat
- Opintojohtaja: Johnson & Johnson Enterprise Innovation Inc. Clinical Trial, Johnson & Johnson Enterprise Innovation Inc.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 90301900NSC2001
- 90301900NSC2001 (Muu tunniste: Janssen Research & Development, LLC)
- 2024-518276-32-00 (Rekisterin tunniste: EUCT number)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
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.
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