Clinical trial · Interventional
A Study of Gimistotug (BGB-A445) in Combination With Other Investigational Agents in Participants With Non-Small Cell Lung Cancer
A Phase 2, Open-label, Randomized, Multi-arm Study of BGB-A445 in Combination With Investigational Agents in Non-Small Cell Lung Cancer Patients Previously Treated With Anti-PD-(L)1 Antibody
NCT06029127CI-TRIAL-00100118completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BGB-15025 | Drug | — | UNRESOLVED |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Gimistotug | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Gimistotug + Docetaxel
- description
- Participants received gimistotug and docetaxel 75 mg/m\^2 both by intravenous infusion once every 3 weeks until disease progression, intolerable toxicity, withdrawal of informed consent, or other discontinuation criterion were met.
- interventionNames
- Drug: Gimistotug
- Drug: Docetaxel
- type
- EXPERIMENTAL
- label
- Gimistotug + BGB-15025
- description
- Participants received gimistotug by intravenous infusion once every 3 weeks and BGB-15025 orally once daily during each 3-week cycle until disease progression, intolerable toxicity, withdrawal of informed consent, or other discontinuation criterion were met.
- interventionNames
- Drug: Gimistotug
- Drug: BGB-15025
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.