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Experimental lung cancer drug shows promise but trial halted early

NCT ID NCT06685718

Disease control Sponsor: BeOne Medicines Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tested an experimental drug called BG-60366 in 33 people with advanced EGFR-mutant non-small cell lung cancer. The drug is designed to break down the faulty EGFR protein that drives cancer growth. The study aimed to check safety and find the right dose, but it was terminated before completion, so full results are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BG-60366 (a drug that breaks down the faulty EGFR protein in cancer cells)
What this could lead to
If it works, this could point toward a new treatment option for people with EGFR-mutant lung cancer whose disease has stopped responding to current therapies.
What could go wrong
This was a very early (Phase 1) trial that was terminated, so results are limited. The drug may not be safe or effective enough to move forward.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

33 people

The number who actually took part.

Started

Dec 2024

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of NSCLC, carrying an EGFR activating mutation prior to receiving standard EGFR-tyrosine kinase inhibitor (EGFR-TKI) * Phase 1a general inclusion criteria: * Disease progression on prior third-generation EGFR-TKI for advanced or metastatic disease, and either progressed or ineligible for currently available standard-of-care treatment (eg, platinum-based chemotherapy) after EGFR-TKI treatment * Phase 1a safety expansion * Documentation of EGFR resistance mutations (ie, C797s) * At least ≥ 1 evaluable lesion (for Phase 1a Dose Escalation) or at least ≥ 1 measurable lesion (for Phase 1a Safety Expansion or Phase 1b Dose Expansion) per RECIST v1.1 * EGFR resistance mutations may be detected locally either from tumor tissue or circulating tumor DNA (ctDNA) in blood, and samples used for detection of resistance mutations must be collected after progression on the most recent systemic antitumor treatment * Adequate organ function * Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 Exclusion Criteria: * Any previous histologic or cytologic evidence of small cell or combined small cell/non-small cell disease in the archival tumor tissue or tumor biopsy before enrollment * Symptomatic spinal cord compression * Brain metastases which are symptomatic and/or requiring emergency treatment (eg, starting steroid, or stereotactic radiation/whole-brain radiation within 2 weeks before first dose of study drug) * Prior treatment with fourth-generation EGFR-TKI, other CDAC/proteolysis-targeting chimeras (PROTAC) compounds targeting EGFR mutations, or other drugs with the mechanism of action specifically targeting EGFR resistance mutations (eg, C797X) (except for the first- to third-generation EGFR-TKIs) * Any history of interstitial lung disease (ILD) or ≥ Grade 2 noninfectious pneumonitis ≤ 2 years before the first dose of study drug, or has current ILD/noninfectious pneumonitis, or where suspected active ILD/noninfectious pneumonitis cannot be ruled out by imaging during screening * Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

lung cancer lung neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

EGFR activating mutation EGFR mutation-related tumors Lung cancer Non-small cell lung cancer NSCLC NSCLC (non-small cell lung carcinoma)

Contacts and locations

Locations

  • Austin Health

    Heidelberg, Victoria, VIC 3084, Australia

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales, NSW 2148, Australia

  • Cancer Research South Australia

    Adelaide, South Australia, SA 5000, Australia

  • Chungbuk National University Hospital

    Cheongju-si, Chungcheongbukdo, 28644, South Korea

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215-5418, United States

  • Fondazione Irccs San Gerardo Dei Tintori Sc Oncologia

    Monza, 20900, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168, Italy

  • Guangdong Provincial Peoples Hospital Huifu Branch

    Guangzhou, Guangdong, 510120, China

  • H Puerta de Hierro Majadahonda

    Majadahonda, 28222, Spain

  • Harbour Cancer and Wellness

    Auckland, 1023, New Zealand

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Vall Dhebron

    Barcelona, 08035, Spain

  • Liverpool Hospital

    Liverpool, New South Wales, NSW 2170, Australia

  • Memorial Sloan Kettering Cancer Center Mskcc

    New York, New York, 10065-6800, United States

  • Ohio State University

    Columbus, Ohio, 43210-1132, United States

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, VIC 3000, Australia

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, QLD 4102, Australia

  • Samsung Medical Center

    GangnamGu, Seoul Teugbyeolsi, 06351, South Korea

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030032, China

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicineqiantang Branch

    Hangzhou, Zhejiang, 310018, China

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006, China

  • The Tumor Hospital Affiliated to Guangxi Medical Universitywuxiang Branch

    Nanning, Guangxi, 530201, China

  • The University of Texas Md Anderson Cancer Center

    Houston, Texas, 77030-4009, United States

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060, China

  • University of Colorado

    Denver, Colorado, 80202-1702, United States

  • Washington University School of Medicine Siteman Cancer Center

    St Louis, Missouri, 63110-1032, United States

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