Phase I Study of Repotrectinib and Osimertinib in NSCLC Patients

PHASE1RecruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

February 11, 2022

Primary Completion Date

April 30, 2026

Study Completion Date

June 30, 2026

Conditions
Nsclc
Interventions
DRUG

Repotrectinib

"Repotrectinib will be taken orally once daily with or without food Part A: Dose escalation phase, with 3 dose levels for repotrectinib: (1) 80 mg QD, (2) 160 mg QD and (3) 160 mg QD for 14 days followed by 160 mg BID; in combination with 80 mg QD of osimertinib~Part B: at the RP2D for all patients in combination with osimertinib."

DRUG

Osimertinib

"Osimertinib will be taken orally at 80 mg once daily with or without food. Part A: lead in dose in monotherapy at 80 mg QD during 14 days. In combination with repotrectinib afterwards. Depending on the safety and PK/ dose dependent interactions (DDIs) readout during the DLT assessment period, osimertinib dose may be adjusted.~Part B: at the RP2D level in combination with repotrectinib"

Trial Locations (4)

28007

RECRUITING

Hospital Universitario Gregorio Marañón, Madrid

29010

RECRUITING

Hospital Regional Universitario de Málaga, Málaga

07120

RECRUITING

Hospital Son Espases, Palma

08018

RECRUITING

Quiron Dexeus, Barcelona

All Listed Sponsors
collaborator

Turning Point Therapeutics, Inc.

INDUSTRY

lead

Instituto Oncológico Dr Rosell

OTHER