OncoMatch/Clinical Trials/NCT04772235
Phase I Study of Repotrectinib and Osimertinib in NSCLC Patients
Is NCT04772235 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Repotrectinib and Osimertinib for nsclc.
Treatment: Repotrectinib · Osimertinib — This is a Phase I study of repotrectinib in combination with osimertinib in patients with advanced or metastatic EGFR mutant non small cell lung cancer (NSCLC). The study will be conducted in 2 parts, Part Ia and Part Ib, and its purpose will be to find the incidence of dose-limiting toxicities (DLTs) as defined by the primary safety and tolerability endpoint. The Phase Ia study will also determine the impact of repotrectinib on osimertinib pharmacokinetics (PK) and the maximum tolerated dose (MTD), if reached, of repotrectinib given in combination with osimertinib and the recommended Phase II dose (RP2D). Dose escalation will be conducted according to a 'Rolling-6' based study design with 3 dose levels for repotrectinib: 80 mg once a day (QD), 160 mg QD or 160 mf QD during 14 days followed by 160 mg twice a day (BID); in combination with 80 mg QD of osimertinib. A total of 6 patients will be enrolled in each dose level cohort. In addition, this Phase Ib study will test early drug activity (efficacy) of the proposed combination treatment in an expansion cohort at the RP2D.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR
Patients must have been locally diagnosed with EGFR activating mutation (including exon 18, exon 19, exon 21 and mutation T790M)
Required: EGFR exon 18
EGFR activating mutation (including exon 18, exon 19, exon 21 and mutation T790M)
Required: EGFR exon 19
EGFR activating mutation (including exon 18, exon 19, exon 21 and mutation T790M)
Required: EGFR exon 21
EGFR activating mutation (including exon 18, exon 19, exon 21 and mutation T790M)
Required: EGFR T790M
EGFR activating mutation (including exon 18, exon 19, exon 21 and mutation T790M)
Excluded: EGFR exon 20 insertion
Known presence of EGFR exon 20 insertion mutation based on most recent applicable molecular testing.
Excluded: EGFR C797S
presence of a tertiary EGFR mutation (i.e., GFR C797S) mutations
Excluded: MET amplification
presence of...hepatocyte growth factor receptor (MET) amplification
Allowed: ALK rearrangement
Patients with advanced solid tumors harboring ALK, ROS1, neurotrophic tyrosine kinase (NTRK) 1, 2, or 3 rearrangements are eligible
Allowed: ROS1 rearrangement
Patients with advanced solid tumors harboring ALK, ROS1, neurotrophic tyrosine kinase (NTRK) 1, 2, or 3 rearrangements are eligible
Allowed: NTRK1 rearrangement
Patients with advanced solid tumors harboring ALK, ROS1, neurotrophic tyrosine kinase (NTRK) 1, 2, or 3 rearrangements are eligible
Allowed: NTRK2 rearrangement
Patients with advanced solid tumors harboring ALK, ROS1, neurotrophic tyrosine kinase (NTRK) 1, 2, or 3 rearrangements are eligible
Allowed: NTRK3 rearrangement
Patients with advanced solid tumors harboring ALK, ROS1, neurotrophic tyrosine kinase (NTRK) 1, 2, or 3 rearrangements are eligible
Disease stage
Required: Stage IV, III (TNM Version 8)
Stage IV, according to Tumor-nodes-metastasis (TNM) Version 8, including M1a (malignant effusion) or M1b (distant metastasis), or locally advanced disease for which there is no curative treatment
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: repotrectinib (repotrectinib)
Lab requirements
Blood counts
absolute neutrophil count (ANC) >1.5 x 10^9/L, platelet count >100.0 x 10^9/L, and hemoglobin >9.0 g/dL (transfusion allowed at baseline)
Kidney function
calculated (Cockcroft-Gault formula) or measured creatinine clearance >50 mL/min and proteinuria <2+ (dipstick)
Liver function
total bilirubin <1.5 x upper limit of normal (ULN), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) <2.5 x ULN
Cardiac function
Mean resting corrected QT interval (QTc) > 470 msec (exclusion); no clinically important abnormalities in rhythm, conduction or morphology of resting ECG; no factors that increase the risk of QTc prolongation or arrhythmic events
Adequate hematological function, defined as: absolute neutrophil count (ANC) >1.5 x 10^9/L, platelet count >100.0 x 10^9/L, and hemoglobin >9.0 g/dL (transfusion allowed at baseline). Adequate liver function, defined as: total bilirubin <1.5 x upper limit of normal (ULN), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) <2.5 x ULN. Adequate renal function, defined as: calculated (Cockcroft-Gault formula) or measured creatinine clearance >50 mL/min and proteinuria <2+ (dipstick). Cardiac: Mean resting corrected QT interval (QTc) > 470 msec (exclusion); no clinically important abnormalities in rhythm, conduction or morphology of resting ECG; no factors that increase the risk of QTc prolongation or arrhythmic events.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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