This is a single-center, open-label Phase 1/2 trial evaluating the safety and efficacy of the combination of larotrectinib and pembrolizumab in patients with advanced/metastatic lung adenocarcinoma or melanoma.
Ability to understand and willingness to sign informed consent form prior to initiation of the study and any study procedures.
Capable of and willing to comply with scheduled visits, treatment plans, laboratory tests, and other study-related tests and procedures.
Age ≥18 years.
Histologically documented locally advanced or metastatic lung adenocarcinoma or melanoma.
Documented alterations in NTRK1, NTRK2, or NTRK3 including fusions, rearrangements, deletions, and single nucleotide variants by DNA sequencing or polymerase chain reaction test on circulating tumor DNA, fresh tumor biopsy, or archival tumor tissue (obtained within 3 years of first larotrectinib dose) performed in a Clinical Laboratory Improvement Amendments-certified or equivalent laboratory.
Patients who required dose interruption for more than 4 weeks, permanent discontinuation, or required systemic immunosuppression due to severe irAEs associated with previous ICI treatment.
Radiation therapy ≥14 days prior to study treatment initiation
Surgical resection ≥28 days prior to study treatment initiation; no evidence of clinical or radiographic progression on CNS imaging ≤28 days prior to study treatment initiation
Single group
Larotrectinib
DrugTaken twice daily
Pembrolizumab
DrugGive by IV infused over 30 minutes through an IV line containing a sterile 0.2 µm to 5 µm in-line or add-on filter.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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This trial is not recruiting at the moment. You can still explore other options:
