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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06667908
Registration number
NCT06667908
Ethics application status
Date submitted
30/10/2024
Date registered
31/10/2024
Date last updated
4/09/2025
Titles & IDs
Public title
A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)
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Scientific 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
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Secondary ID [1]
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90301900NSC2001
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Secondary ID [2]
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90301900NSC2001
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Universal Trial Number (UTN)
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Trial acronym
CONVERGE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Non-Small-Cell Lung
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Condition category
Condition code
Cancer
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Lung - Non small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - JNJ-90301900
Treatment: Other - Durvalumab
Treatment: Other - Concurrent Chemo/Radiation Therapy (cCRT)
Treatment: Drugs - Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin
Treatment: Drugs - Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel
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.
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.
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.
Treatment: Drugs: JNJ-90301900
JNJ-90301900 will be injected intratumorally and/or intranodally.
Treatment: Other: Durvalumab
Durvalumab will be administered as intravenous (IV) infusion as cIT.
Treatment: Other: Concurrent Chemo/Radiation Therapy (cCRT)
Radiation by intensity modulated radiation therapy (IMRT) will be administered.
Treatment: Drugs: Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin
Carboplatin will be administered as IV infusion as platinum-based doublet chemotherapy.
Treatment: Drugs: Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel
Paclitaxel will be administered as IV infusion as platinum-based doublet chemotherapy.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Objective Response Rate (ORR) Using Independent Central Review (ICR) Assessment
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Assessment method [1]
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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.
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Timepoint [1]
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Up to 2 Years and 2 months
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Secondary outcome [1]
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Disease Response Rate (ORR) Post-cCRT and Pre-cIT
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Assessment method [1]
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Disease 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.
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Timepoint [1]
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Up to 12 Weeks
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Secondary outcome [2]
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Disease Control Rate (DCR) Post-cCRT and Pre-cIT
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Assessment method [2]
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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.
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Timepoint [2]
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Up to 12 Weeks
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Secondary outcome [3]
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Objective Response Rate (ORR) as Assessed by the Investigator
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Assessment method [3]
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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.
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Timepoint [3]
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Up to 2 Years and 2 months
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Secondary outcome [4]
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Progression Free Survival (PFS)
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Assessment method [4]
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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.
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Timepoint [4]
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Up to 2 Years and 2 months
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Secondary outcome [5]
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Duration of Response (DoR)
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Assessment method [5]
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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.
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Timepoint [5]
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Up to 2 Years and 2 months
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Secondary outcome [6]
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Time to Locoregional Failure (LRF)
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Assessment method [6]
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Time to LRF is defined as the time from enrollment/randomization to the first LRF using ICR assessments.
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Timepoint [6]
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Up to 2 Years and 2 months
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Secondary outcome [7]
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Time to Distant Failure (DF)
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Assessment method [7]
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Time to DF is defined as the time from enrollment/randomization to the first DF using ICR assessments.
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Timepoint [7]
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Up to 2 Years and 2 months
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Secondary outcome [8]
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Number of Participants with Treatment-Emergent Adverse Event (TEAE) Related to Study Treatment
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Assessment method [8]
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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.
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Timepoint [8]
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Up to 2 Years and 2 months
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Secondary outcome [9]
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Number of Participants Reporting Laboratory Parameters, Physical Examination, Vital Signs Including Eastern Cooperative Oncology Group (ECOG) Performance Status Abnormalities
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Assessment method [9]
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Participants with laboratory parameters, physical examination, vital signs including ECOG performance status abnormalities will be reported.
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Timepoint [9]
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Up to 2 Years and 2 months
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/12/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2028
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Actual
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Sample size
Target
130
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Melbourne Hospital - Parkville
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Recruitment postcode(s) [1]
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3050 - Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Connecticut
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Georgia
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Country [4]
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United States of America
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State/province [4]
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New York
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Country [5]
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United States of America
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State/province [5]
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North Carolina
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Country [6]
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United States of America
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State/province [6]
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Pennsylvania
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Country [7]
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United States of America
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State/province [7]
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Texas
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Country [8]
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United States of America
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State/province [8]
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Vermont
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Country [9]
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Spain
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State/province [9]
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Madrid
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Country [10]
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Spain
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State/province [10]
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Pamplona
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Country [11]
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Spain
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State/province [11]
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Santiago de Compostela
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Country [12]
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Spain
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State/province [12]
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Valencia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Johnson & Johnson Enterprise Innovation Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT06667908
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Johnson & Johnson Enterprise Innovation Inc. Clinical Trial
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Address
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Johnson & Johnson Enterprise Innovation Inc.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Study Contact
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Address
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Country
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Phone
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844-434-4210
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06667908
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