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

August 27, 2026 updated by: Johnson & Johnson Enterprise Innovation Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
        • Hopital De La Cavale Blanche
      • Marseille, France, 13015
        • Recruiting
        • Hôpital 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
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • Moores Cancer Center at UC San Diego Health
    • 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
    • Missouri
      • St Louis, Missouri, United States, 63130
        • Recruiting
        • Washington University in St Louis
    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) Using Independent Central Review (ICR) Assessment
Time Frame: Up to 2 Years and 2 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disease Control Rate (DCR) Post-cCRT and Pre-cIT
Time Frame: Up to 12 Weeks
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
Time Frame: Up to 2 Years and 2 months
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)
Time Frame: Up to 2 Years and 2 months
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)
Time Frame: Up to 2 Years and 2 months
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 Frame: Up to 2 Years and 2 months
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 Frame: Up to 2 Years and 2 months
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
Time Frame: Up to 2 Years and 2 months
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
Time Frame: Up to 2 Years and 2 months
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
Time Frame: Up to 12 Weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johnson & Johnson Enterprise Innovation Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Johnson & Johnson Enterprise Innovation Inc. Clinical Trial, Johnson & Johnson Enterprise Innovation Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 6, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 31, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings