A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)
CONVERGE
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
2 other identifiers
interventional
130
10 countries
41
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2024
Typical duration for phase_2
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2024
CompletedFirst Posted
Study publicly available on registry
October 31, 2024
CompletedStudy Start
First participant enrolled
December 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
June 5, 2026
June 1, 2026
4.1 years
October 30, 2024
June 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR) Using Independent Central Review (ICR) Assessment
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
Secondary Outcomes (9)
Objective Response Rate (ORR) Post-cCRT and Pre-cIT
Up to 12 Weeks
Disease Control Rate (DCR) Post-cCRT and Pre-cIT
Up to 12 Weeks
Objective Response Rate (ORR) as Assessed by the Investigator
Up to 2 Years and 2 months
Progression Free Survival (PFS)
Up to 2 Years and 2 months
Duration of Response (DoR)
Up to 2 Years and 2 months
- +4 more secondary outcomes
Study Arms (3)
Part 1: Cohort A and Cohort B
EXPERIMENTALParticipants 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.
Part 2: Arm A and Arm B
EXPERIMENTALParticipants 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.
Part 2: Arm C: (Control treatment)
ACTIVE COMPARATORParticipants will receive treatment with cCRT followed by cIT as control treatment to evaluate the efficacy and safety of JNJ-90301900.
Interventions
Carboplatin will be administered as IV infusion as platinum-based doublet chemotherapy.
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.
Paclitaxel will be administered as IV infusion as platinum-based doublet chemotherapy.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
University of Connecticut Health Center
Farmington, Connecticut, 06030, United States
Yale University
New Haven, Connecticut, 06519, United States
University of Miami
Miami, Florida, 33136, United States
Orlando Health Cancer Institute
Orlando, Florida, 32806, United States
Emory University Winship Cancer Institute
Atlanta, Georgia, 30306, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
NYU Langone Health
New York, New York, 10016, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
FirstHealth of the Carolinas
Pinehurst, North Carolina, 28374, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Oregon Health And Science University
Portland, Oregon, 97239, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
Royal Brisbane and Women's Hospital
Herston, 4029, Australia
Sir Charles Gairdner Hospital
Nedlands, 6009, Australia
Macquarie University
North Ryde, 2109, Australia
Royal Melbourne Hospital
Parkville, 3050, Australia
Fundacao Pio XII
Barretos, 14784 400, Brazil
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo, 01308 050, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, 05651 901, Brazil
Dongguan People s Hospital
Dongguan, 523109, China
The First Affiliated Hospital Sun Yat sen University
Guangzhou, 510080, China
The Affiliated Cancer Hospital of Shandong First Medical University
Jinan, 250117, China
Hopital De La Cavale Blanche
Brest, 29200, France
Hopital Nord Marseille
Marseille, 13015, France
Hopital Tenon
Paris, 75020, France
Institut Curie
Paris, 75248, France
Gustave Roussy
Villejuif, 94805, France
Prince of Wales Hospital
Shatin, Hong Kong
Antoni van Leeuwenhoek
Amsterdam, 1066 CX, Netherlands
Radboud Umcn
Nijmegen, 6525 GA, Netherlands
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Clinica Univ. de Navarra
Pamplona, 31008, Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706, Spain
Hosp. Univ. I Politecni La Fe
Valencia, 46026, Spain
Marmara University Pendik Training Hospital
Istanbul, 34899, Turkey (Türkiye)
Sakarya University Training and Research Hospital
Sakarya, 54100, Turkey (Türkiye)
University College London Hospitals
London, NW1 2BU, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Enterprise Innovation Inc. Clinical Trial
Johnson & Johnson Enterprise Innovation Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2024
First Posted
October 31, 2024
Study Start
December 6, 2024
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
June 5, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
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.