A PHASE II STUDY OF PRALSETINIB IN PATIENTS WITH PREVIOUSLY TREATED RET FUSIONPOSITIVE NON-SMALL CELL LUNG CANCER

A PHASE II STUDY OF PRALSETINIB IN PATIENTS WITH PREVIOUSLY TREATED RET FUSION-POSITIVE NON-SMALL CELL LUNG CANCER

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2021210074

Enrollment

Registered

2022-03-12

Start date

2022-06-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PREVIOUSLY TREATED RET FUSION-POSITIVE NON-SMALL CELL LUNG CANCER

Interventions

pralsetinib Hydrate: Pralsetinib Hydrate will be administered orally, once daily at a dose of 400 mg.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -ECOG PS is 0 or 1. -Histologically or cytologically confirmed non-small cell lung cancer. -Positive for RET fusion gene.

Exclusion criteria

Exclusion criteria: -Known major driver mutations in addition to RET fusion gene positivity -There has been a history of administration of other selective RET inhibitors

Design outcomes

Primary

Measure	Time frame
Efficacy Efficacy based on RECIST v1.1	—

Secondary

Measure	Time frame
Safety, Efficacy, Phamacokinetics -Safety (incidence of adverse events based on NCI CTCAE) -Efficacy based on RECIST v1.1 -Overall survival (OS) -Pharmacokinetics -Gene expression status	—

Contacts

Public ContactClinical trials information

Chugai Pharmaceutical Co., Ltd.

clinical-trials@chugai-pharm.co.jp+81-120-189-706

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026