Tipifarnib and Osimertinib in EGFR-mutated Non-Small Cell Lung Cancer

Withdrawn before enrolling · Phase 1

Conditions studied: NSCLC

In brief

This is a Phase 1a/b, multicenter, open-label, dose escalation (1a) and dose expansion (1b) study. The purpose of this study is to measure safety, tolerability, and preliminary efficacy with the combination of tipifarnib with osimertinib in patients with advanced/metastatic EGFR-mutated non-small cell lung cancer.

Key facts

Study ID

NCT05693090

Run by

Kura Oncology, Inc.

People needed

0

Starts

2023-02-01

Expected to finish

2027-07-27

Last updated by the study team

2023-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years at the time of signing informed consent.
• Histologically or cytologically confirmed stage IIIB (locally-advanced) or IV (metastatic) adenocarcinoma of the lung.
• The tumor harbors an Ex19del or Ex21-L858R substitution (based on tumor tissue or plasma [ctDNA] assessment).
• Treatment-naïve for locally advanced/metastatic EGFR-mutated NSCLC and osimertinib treatment-naïve for NSCLC.
• ECOG performance score of 0 or 1 with no clinically significant deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
• Measurable disease by RECIST v1.1 that meets the criteria for selection as a target lesion according to RECIST v1.1.
• Adequate organ function, as evidenced by the laboratory results.
• Other protocol-defined inclusion criteria may apply.

You may not qualify if…

• Treatment with any of the following:
• Major surgery
• Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug
• Medications or herbal supplements known to be potent inhibitors or inducers of cytochrome P450 (CYP) 3A4 or uridine 5'-diphospho (UDP)-glucuronosyltransferase (UGT), or inhibitors of breast cancer resistance protein (BCRP).
• Investigational therapy within 2 weeks of Cycle 1 Day 1
• Concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of study drug (excluding non-melanoma skin cancer, adjuvant hormonal therapy for breast cancer and hormonal treatment for castration-sensitive prostate cancer)
• Spinal cord compression or symptomatic and unstable brain metastases requiring steroids over the last 4 weeks prior.
• Evidence of severe or uncontrolled systemic diseases.
• Refractory nausea and vomiting, chronic gastrointestinal (GI) diseases, inability to swallow the formulated product, or previous significant bowel resection.
• Clinically significant cardiovascular symptoms or disease.
• Received treatment for unstable angina within prior year, myocardial infarction within the prior 6 months, cerebro-vascular attack within the prior year, history of New York Heart Association grade III or greater congestive heart failure, or current serious cardiac arrhythmia requiring medication except atrial fibrillation.
• Past medical history of Interstitial Lung Disease (ILD), drug induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
• Other protocol-defined exclusion criteria may apply.

Where it is running

• Providence Medical Group — Santa Rosa, California, United States
• The Valley Hospital — Ridgewood, New Jersey, United States

Full record on ClinicalTrials.gov

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