Carcinoma, Non-Small-Cell LungPhase 2CONVERGENCT06667908
A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing JNJ-90301900, Durvalumab and Concurrent Chemo/Radiation Therapy (cCRT) in people with Carcinoma, Non-Small-Cell Lung, run by Johnson & Johnson Enterprise Innovation Inc. at 44 sites in 10 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- JNJ-90301900, Durvalumab and Concurrent Chemo/Radiation Therapy (cCRT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 44 sitesin 10 countries
- Study dates
- 6 Dec 2024to 31 Dec 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
44 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
44 sites in 10 countries
United States18 sites, 17 recruiting
- Recruiting
Emory University Winship Cancer Institute
Atlanta, Georgia, 30306
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
- Recruiting
University of Vermont Medical Center
Burlington, Vermont, 05401
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
- Completed
University of Connecticut Health Center
Farmington, Connecticut, 06030
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Moores Cancer Center at UC San Diego Health
La Jolla, California, 92037
- Recruiting
University of Miami
Miami, Florida, 33136
- Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
- Recruiting
Yale University
New Haven, Connecticut, 06519
- Recruiting
NYU Langone Health
New York, New York, 10016
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Recruiting
Orlando Health Cancer Institute
Orlando, Florida, 32806
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
- Recruiting
FirstHealth of the Carolinas
Pinehurst, North Carolina, 28374
- Recruiting
Oregon Health And Science University
Portland, Oregon, 97239
- Recruiting
Washington University in St Louis
St Louis, Missouri, 63130
France6 sites, 6 recruiting
- Recruiting
Hopital De La Cavale Blanche
Brest, 29200
- Recruiting
Hopital Nord Marseille
Marseille, 13015
- Recruiting
Hopital Tenon
Paris, 75020
- Recruiting
Institut Curie
Paris, 75248
- Recruiting
CHU Rouen Hopital Charles Nicolle
Rouen, 76000
- Recruiting
Gustave Roussy
Villejuif, 94805
Australia4 sites, 4 recruiting
- Recruiting
Royal Brisbane and Women's Hospital
Herston, 4029
- Recruiting
Sir Charles Gairdner Hospital
Nedlands, 6009
- Recruiting
Macquarie University
North Ryde, 2109
- Recruiting
Royal Melbourne Hospital
Parkville, 3050
Spain4 sites, 4 recruiting
- Recruiting
Hosp. Univ. 12 de Octubre
Madrid, 28041
- Recruiting
Clinica Univ. de Navarra
Pamplona, 31008
- Recruiting
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706
- Recruiting
Hosp. Univ. I Politecni La Fe
Valencia, 46026
Brazil3 sites, 3 recruiting
- Recruiting
Fundacao Pio XII
Barretos, 14784 400
- Recruiting
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo, 01308 050
- Recruiting
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, 05651 901
China3 sites, 3 recruiting
- Recruiting
Dongguan People s Hospital
Dongguan, 523109
- Recruiting
The First Affiliated Hospital Sun Yat sen University
Guangzhou, 510080
- Recruiting
The Affiliated Cancer Hospital of Shandong First Medical University
Jinan, 250117
Netherlands2 sites, 2 recruiting
- Recruiting
Antoni van Leeuwenhoek
Amsterdam, 1066 CX
- Recruiting
Radboud Umcn
Nijmegen, 6525 GA
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Marmara University Pendik Training Hospital
Istanbul, 34899
- Recruiting
Sakarya University Training and Research Hospital
Sakarya, 54100
United Kingdom1 site, 1 recruiting
- Recruiting
University College London Hospitals
London, NW1 2BU
About this study
Official title: 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.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- JNJ-90301900, Durvalumab, Concurrent Chemo/Radiation Therapy (cCRT), Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin, Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-90301900Drug
JNJ-90301900 will be injected intratumorally and/or intranodally.
DurvalumabBiological
Durvalumab will be administered as intravenous (IV) infusion as cIT.
Concurrent Chemo/Radiation Therapy (cCRT)Radiation
Radiation by intensity modulated radiation therapy (IMRT) will be administered.
Concurrent Chemo/Radiation Therapy (cCRT): CarboplatinDrug
Carboplatin will be administered as IV infusion as platinum-based doublet chemotherapy.
Concurrent Chemo/Radiation Therapy (cCRT): PaclitaxelDrug
Paclitaxel will be administered as IV infusion as platinum-based doublet chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Cohort A and Cohort B | Experimental | 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. Receives: 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 |
| Part 2: Arm A and Arm B | Experimental | 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. Receives: 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 |
| Part 2: Arm C: (Control treatment) | Active comparator | Participants will receive treatment with cCRT followed by cIT as control treatment to evaluate the efficacy and safety of JNJ-90301900. Receives: Biological: Durvalumab; Radiation: Concurrent Chemo/Radiation Therapy (cCRT); Drug: Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin; Drug: Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 Years and 2 months
Secondary outcomes (9)
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.
Measured: Up to 12 Weeks
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 2 Years and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start6 Dec 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Enterprise Innovation Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Enterprise Innovation Inc. Clinical Trial, Study director, Johnson & Johnson Enterprise Innovation Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667908
- Sponsor's protocol ID
- 90301900NSC2001
- Other IDs
- 90301900NSC2001, 2024-518276-32-00
- Acronym
- CONVERGE
- Status last verified
- Sep 2026
- First submitted
- 30 Oct 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.