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A Study Investigating BG-60366 in Adults With Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer

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NCT06685718

Sponsored by BeOne Medicines (industry) · ONC — their whole pipeline →.

Phase
Phase 1
Status
Terminated
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
33actual
Sites
29
Countries
Australia, China, Italy +4

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Why the sponsor stopped it

Evaluation on business strategy, not involving safety issue.

As filed on the registry record, in the sponsor's own words.

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2024-12-05actualWhen the study began enrolling
Primary completion2026-04-21actualThe date the last participant is measured for the primary outcome — the readout window
Study completion2026-04-21actualThe whole study's end, after follow-up
First posted2024-11-12actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-05-22actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

  • Non-Small Cell Lung Cancer
  • Lung Cancer
  • NSCLC
  • NSCLC (Non-small Cell Lung Carcinoma)
  • EGFR Activating Mutation
  • EGFR Mutation-Related Tumors

Intervention

  • Drug: BG-60366

Primary outcomes

what the primary-completion date above is the date OF
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
measured From first dose of the study drug to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first (approximately 18 months)
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD)
measured Approximately 1 month
Phase 1a: Recommended dose(s) for expansion (RDFE) of BG-60366
measured Approximately 18 months
Phase 1b: Number of Participants with Adverse Events and Serious Adverse Events
measured From first dose of the study drug to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first (approximately 24 months)
Phase 1b: Overall Response Rate (ORR)
measured Approximately 24 months

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