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CONVERGE: JNJ-90301900 + cCRT + Durvalumab in Stage III NSCLC
NCT06667908Phase 2
Key facts
- Status
- Recruiting
- Start
- Dec 2024
- Primary completion
- Dec 2028
- Countries
- 10
- Sponsor
- Johnson & Johnson
- Modality
- Nanoparticles, Small Molecules
- Drugs
- NBTXR3
- Conditions
- non-small cell lung cancer (NSCLC)
01
Overview
Phase 2, randomised, open-label trial of NBTXR3 in non-small cell lung cancer (NSCLC) (3 arms), sponsored by Johnson & Johnson. Primary endpoint: Objective Response Rate Using Independent Central Review (ICR) Assessment. Started Dec 2024; status: recruiting.
02
Design
3 arms- Study design
- RandomizedOpen-label
Part 1: Cohort A and Cohort B
JNJ-90301900 + cCRT followed by Durvalumab
Part 2: Arm A and Arm B
JNJ-90301900 + cCRT followed by Durvalumab
Part 2: Arm C: (Control treatment)
cCRT followed by Durvalumab
03
Who it enrols
Patients with locally advanced unresectable stage III NSCLC, ECOG 0-1, candidate for SOC cCRT followed by durvalumab, with at least 1 target lesion amenable to injection.
04
Endpoints
Primary
Objective Response Rate Using Independent Central Review (ICR) Assessment
Secondary
Objective Response Rate Post-cCRT and Pre-cIT
Disease Control Rate Post-cCRT and Pre-cIT
Objective Response Rate as Assessed by the Investigator
Progression Free Survival
Duration of Response
Time to Locoregional Failure
Time to Distant Failure
Number of Participants with Treatment-Emergent Adverse Event (TEAE) Related to Study Treatment
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