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

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.

Study Overview

• Status: Recruiting
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Drug: JNJ-90301900; Biological: Durvalumab; Radiation: Concurrent Chemo/Radiation Therapy (cCRT); Drug: Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin; Drug: Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study1@its.jnj.com

Study Locations

• Australia
  • Herston, Australia, 4029
    • Recruiting
    • Royal Brisbane and Women's Hospital
  • Nedlands, Australia, 6009
    • Recruiting
    • Sir Charles Gairdner Hospital
  • North Ryde, Australia, 2109
    • Recruiting
    • Macquarie University
  • Parkville, Australia, 3050
    • Recruiting
    • Royal Melbourne Hospital
• Brazil
  • Barretos, Brazil, 14784 400
    • Recruiting
    • Fundação Pio XII
  • São Paulo, Brazil, 05651 901
    • Recruiting
    • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
  • São Paulo, Brazil, 01308 050
    • Recruiting
    • Sociedade Beneficente de Senhoras Hospital Sirio Libanes
• China
  • Dongguan, China, 523109
    • Recruiting
    • Dongguan People s Hospital
  • Guangzhou, China, 510080
    • Recruiting
    • The First Affiliated Hospital Sun Yat sen University
  • Jinan, China, 250117
    • Recruiting
    • The Affiliated Cancer Hospital of Shandong First Medical University
• France
  • Brest, France, 29200
    • Recruiting
    • Hôpital de la Cavale Blanche
  • Marseille, France, 13015
    • Recruiting
    • Hopital Nord Marseille
  • Paris, France, 75248
    • Recruiting
    • Institut Curie
  • Paris, France, 75020
    • Recruiting
    • Hôpital Tenon
  • Villejuif, France, 94805
    • Recruiting
    • Gustave Roussy
• Hong Kong
  • Shatin, Hong Kong
    • Recruiting
    • Prince of Wales Hospital
• Netherlands
  • Amsterdam, Netherlands, 1066 CX
    • Recruiting
    • Antoni van Leeuwenhoek
  • Nijmegen, Netherlands, 6525 GA
    • Recruiting
    • Radboud Umcn
• Spain
  • Madrid, Spain, 28041
    • Recruiting
    • Hosp. Univ. 12 de Octubre
  • Pamplona, Spain, 31008
    • Recruiting
    • Clinica Univ. de Navarra
  • Santiago de Compostela, Spain, 15706
    • Recruiting
    • Hosp. Clinico Univ. de Santiago
  • Valencia, Spain, 46026
    • Recruiting
    • Hosp. Univ. I Politecni La Fe
• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye), 34899
    • Recruiting
    • Marmara University Pendik Training Hospital
  • Sakarya, Turkey (Türkiye), 54100
    • Recruiting
    • Sakarya University Training and Research Hospital
• United Kingdom
  • London, United Kingdom, NW1 2BU
    • Recruiting
    • University College London Hospitals
• United States
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • Recruiting
      • University of Connecticut Health Center
    • New Haven, Connecticut, United States, 06519
      • Recruiting
      • Yale University
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
    • Orlando, Florida, United States, 32806
      • Recruiting
      • Orlando Health Cancer Institute
  • Georgia
    • Atlanta, Georgia, United States, 30306
      • Recruiting
      • Emory University Winship Cancer Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Beth Israel Deaconess Medical Center
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Recruiting
      • Rutgers Cancer Institute of New Jersey
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Recruiting
      • University of North Carolina at Chapel Hill
    • Pinehurst, North Carolina, United States, 28374
      • Recruiting
      • FirstHealth of the Carolinas
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Cleveland Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health and Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Recruiting
      • University of Vermont Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Control Rate (DCR) Post-cCRT and Pre-cIT	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
Objective Response Rate (ORR) as Assessed by the Investigator	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
Progression Free Survival (PFS)	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
Duration of Response (DoR)	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
Time to Locoregional Failure (LRF)	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
Time to Distant Failure (DF)	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
Number of Participants with Treatment-Emergent Adverse Event (TEAE) Related to Study Treatment	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
Number of Participants Reporting Laboratory Parameters, Physical Examination, Vital Signs Including Eastern Cooperative Oncology Group (ECOG) Performance Status Abnormalities	Participants with laboratory parameters, physical examination, vital signs including ECOG performance status abnormalities will be reported.	Up to 2 Years and 2 months
Objective Response Rate (ORR) Post-cCRT and Pre-cIT	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

Collaborators and Investigators

• Sponsor: Johnson & Johnson Enterprise Innovation Inc.
• Investigators: Study Director: Johnson & Johnson Enterprise Innovation Inc. Clinical Trial, Johnson & Johnson Enterprise Innovation Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Actual): October 31, 2024

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Therapeutics; Radiotherapy; durvalumab
• Other Study ID Numbers: 90301900NSC2001 (Other Identifier: Janssen Research & Development, LLC); 2024-518276-32-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No