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Study details
Enrolling now

A Study of Neladalkib (NVL-655)

Nuvalent Inc.
NCT IDNCT05384626ClinicalTrials.gov data as of Apr 2026
Phase

Phase 1/2

Target enrollment

840

Study length

about 5.6 years

Ages

12+

Locations

21 sites in CA, CO, DC +14

About this study

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.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Take Neladalkib (NVL-655)
PhasePhase 1/Phase 2
Primary goalNumber of participants with treatment-emergent adverse events, as assessed by CTCAE, V5.0 (Phase 1)

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low8%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Endpoints

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)

Body systems

Oncology