A PHASE II STUDY OF PRALSETINIB IN PATIENTS WITH PREVIOUSLY TREATED RET FUSIONPOSITIVE NON-SMALL CELL LUNG CANCER
Phase 2
Suspended
- Conditions
- PREVIOUSLY TREATED RET FUSION-POSITIVE NON-SMALL CELL LUNG CANCER
- Registration Number
- JPRN-jRCT2021210074
- Lead Sponsor
- Iwasawa Shunichiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
ECOG PS is 0 or 1.
-Histologically or cytologically confirmed non-small cell lung cancer.
-Positive for RET fusion gene.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy<br>Efficacy based on RECIST v1.1
- Secondary Outcome Measures
Name Time Method Safety, Efficacy, Phamacokinetics<br>-Safety (incidence of adverse events based on NCI CTCAE)<br>-Efficacy based on RECIST v1.1<br>-Overall survival (OS)<br>-Pharmacokinetics<br>-Gene expression status