CONVERGE
Lung cancer
INTRATUMORAL STUDY.
A Phase 2, randomized, open-label study of JNJ-90301900 (NBTXR3)/RT plus chemoradiation followed by durvalumab in locally advanced and unresectable stage 3 NSCLC
A Phase 2, randomized, open-label study of JNJ-90301900 (NBTXR3)/RT plus chemoradiation followed by durvalumab in locally advanced and unresectable stage 3 NSCLC
Phase
Compound
JNJ-90301900 (NBTXR3) + cCRT + durvalumabIntratumoral study
NCT identifier
NCT06667908
Enrollment
N=~130
For more information, including
contact details, please visit
the J&J Clinical Trial Finder
contact details, please visit
the J&J Clinical Trial Finder
Study overview & design
Key eligibility criteria*:
- Locally advanced, unresectable, stage 3 NSCLC
- Candidate for SOC treatment of NSCLC by cCRT, followed by consolidation durvalumab treatment
- ≥1 target lesion (primary lung lesion or involved lymph nodes) amenable to intratumoral and/or intranodal injection and IMRT
- ECOG PS 0 or 1
Study
design
Primary outcome:
- ORR
Secondary outcomes‡:
- PFS
- DOR
- ORR post-cCRT and pre-cIT, DCR post-cCRT, and pre-cIT
- Time to locoregional and distant failure
- Safety
*Not a complete list of inclusion and exclusion criteria. †And/or intranodal injection. ‡Not a
complete list of secondary outcomes.
cCRT, concurrent chemoradiotherapy; cIT, cancer immunotherapy; DCR, disease
control rate; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; IMRT,
intensity-modulated radiation therapy; NSCLC, non–small cell lung cancer; ORR, objective response rate; PFS,
progression-free survival; R, randomized; RT, radiation therapy; SOC, standard of care.