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Investigating a new treatment for adults with EGFR-mutant non-small cell lung cancer

Phase 1a/1b, Open-Label Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of a CDAC Degrading EGFR, BG-60366, in Patients With EGFR-Mutant Non-Small Cell Lung Cancer

Phase 1 Interventional BeiGene · NCT06685718

This study is testing a new targeted therapy for adults with advanced lung cancer that has a specific mutation to see if it can help shrink tumors after other treatments have stopped working.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment93 (estimated)
Ages18 Years and up
SexAll
SponsorBeiGene Industry-sponsored
Drugs / interventionschemotherapy, radiation
Locations43 sites (Denver, Colorado and 42 other locations)
Trial IDNCT06685718 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter Phase 1 clinical study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-60366, a targeted therapy designed to degrade mutant EGFR in patients with advanced or metastatic non-small cell lung cancer (NSCLC). The study consists of two parts: a dose escalation and safety expansion phase, followed by a dose expansion phase. Participants must have a confirmed diagnosis of NSCLC with an EGFR activating mutation and have experienced disease progression on prior treatments.

Who should consider this trial

Good fit: Ideal candidates are adults with advanced or metastatic non-small cell lung cancer carrying an EGFR activating mutation who have progressed on prior EGFR-tyrosine kinase inhibitors.

Not a fit: Patients without an EGFR activating mutation or those who have not progressed on prior EGFR-TKIs may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with EGFR-mutant NSCLC who have limited treatment alternatives.

How similar studies have performed: Other studies targeting EGFR mutations have shown promise, indicating potential for success with this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Denver, Colorado and 42 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-Small Cell Lung CancerLung CancerNSCLCEGFR Activating MutationEGFR Mutation-Related Tumorslung cancernon-small cell lung cancerEGFR activating mutation
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.