Phase 2
Completed N=35
A Study of Gimistotug (BGB-A445) in Combination With Other Investigational Agents in Participants With Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT06029127 ↗
Enrolled (actual)
35
Serious AEs
25.7%
Results posted
Jan 2026
Primary outcomePrimary: Overall Response Rate — 0.0; 0.0 percentage of participants
Summary
The main objective of this study was to evaluate the anti-tumor activity of gimistotug (BGB-A445) plus investigational agents in participants with non-small cell lung cancer (NSCLC).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate |
0.0; 0.0 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
20; 12; 8; 1 | — |
| SECONDARY Duration of Response (DOR) |
— | — |
| SECONDARY Disease Control Rate (DCR) |
71.4; 21.4 | — |
| SECONDARY Clinical Benefit Rate (CBR) |
19.0; 0.0 | — |
| SECONDARY Serum Concentrations of Gimistotug |
737.95; 846.58; 99.84; 105.90; 163.77; 222.92 | — |
| SECONDARY Plasma Concentrations of BGB-15025 |
0.36; 0.49; 0.29; 0.25; 0.18; 0.47 | — |
| SECONDARY Number of Participants With Anti-Drug Antibodies to Gimistotug |
2; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Advanced or metastatic NSCLC (nonsquamous or squamous) that is histologically or cytologically confirmed
- Participants who have received no more than 2 lines of prior systemic therapies which must include anti-programmed cell death protein ligand-1 (anti-PD-(L)1) treatment and a platinum-based chemotherapy administered in combination with, or sequentially before or after the anti-PD-(L)1 treatment
- At least 1 measurable lesion as defined per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate organ function as indicated by laboratory values during screening
Exclusion Criteria
- With mixed small cell lung cancer
- Has received prior therapy targeting OX40 or any other T-cell agonists
- Has received prior therapy containing docetaxel and/or ramucirumab for advanced or metastatic NSCLC
- Has received any Chinese herbal medicine or Chinese patent medicines used to control cancer ≤ 14 days before the first dose of study drug(s)
- Active leptomeningeal disease or uncontrolled and untreated brain metastasis
NOTE: Other criteria may apply
Data sourced from ClinicalTrials.gov (NCT06029127). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.