A Study of Neladalkib (NVL-655)
Phase 1/2
840
about 5.6 years
12+
21 sites in CA, CO, DC +14
What this study is about
Researchers are testing a treatment called neladalkib (NVL-655) in people with advanced lung cancer and other solid tumors that have ALK rearrangements or activating ALK mutations. The trial will evaluate the safety, tolerability, and effectiveness of this treatment.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Neladalkib (NVL-655)
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Primary: Number of participants with treatment-emergent adverse events, as assessed by CTCAE, V5.0 (Phase 1), Objective Response Rate (ORR) (Phase 2)
Secondary: Clinical benefit rate (CBR), Duration of response (DOR), Half-life (t1/2) of neladalkib (NVL-655), Maximum plasma concentration, (Cmax) of neladalkib (NVL-655), Number of participants with treatment-emergent adverse events, as assessed by CTCAE, V5.0 (Phase 2), Objective response rate (ORR) (Phase 1), Oral clearance (CL/F) of neladalkib (NVL-655), Overall survival (OS) (Phase 2)
Oncology