RecruitingMetastatic Lung Non-Small Cell CarcinomaStage IV Lung Cancer AJCC v8Stage IVA Lung Cancer AJCC v8

Osimertinib and Tegavivint as First-Line Therapy for the Treatment of Metastatic EGFR-Mutant Non-small Cell Lung Cancer

Eligible age

18+ yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

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About this study

This phase Ib trial is to find out the best dose, possible benefits and/or side effects of osimertinib and tegavivint as first-line therapy in treating patients with EGFR-mutant non-small cell lung cancer that has spread to other places in the body (metastatic). Osimertinib and tegavivint may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Sponsor: Ohio State University Comprehensive Cancer Center

You may qualify if…

✓ Age \>= 18 years. Children are excluded from this study because neither dosing nor safety data are currently available for AZD9291 or BC2059 in patients \< 18 years of age
✓ Pathology-confirmed metastatic NSCLC
✓ A common activating mutation must be present in the EGFR gene, i.e., exon 19 deletion or L858R. The presence of uncommon EGFR mutations, e.g., G719X, S768I, or L861Q are also permitted if they co-occur with a common activating mutation. Mutation status must be determined using a tumor biopsy by local Clinical Laboratory Improvement Act (CLIA)-certified assessment. Mutations identified by blood-based testing can be provided, but must be verified by tumor biopsy
✓ The presence of a concurrent T790M mutation, while uncommon in patients who are naïve to treatment with EGFR TKIs, is also permitted
✓ Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria
✓ Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
✓ The patient must be able to swallow pills
✓ Life expectancy \> 3 months

You may not qualify if…

✕ Prior treatment with an EGFR TKI in any setting
✕ Patients who have not recovered from adverse events (AEs) due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1), with the exception of alopecia
✕ Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active interstitial lung disease
✕ Patients who are receiving any other investigational agent or immunotherapy within five half-lives of the compound or 3 months, whichever is greater
✕ Patients with an uncontrolled intercurrent illness
✕ Patients with psychiatric illness/social situations that would limit compliance with study requirements
✕ History of allergic reactions attributed to compounds of similar chemical or biologic composition as BC2059 or AZD9291. Patients with hypersensitivity to any of the inactive excipients should also be excluded
✕ Currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4 (wash-out periods vary. All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4

Where it's recruiting

Ohio

Columbus

Source: ClinicalTrials.gov · NCT04780568 · last updated 2025-12-09