Clinical trial · Interventional
A Phase II, Open Label, Multiple Arm Study of AUY922, BYL719, INC280, LDK378 and MEK162 in Chinese Patients With Advanced Non-small Cell Lung Cancer
A Phase II, Open Label, Multiple Arm Study of Single Agent AUY922, BYL719, INC280, LDK378 and MEK162 in Chinese Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
- 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 purpose of this study was to evaluate the anti-tumor activity of single agent BYL719, INC280, LDK378 and MEK162 in advanced NSCLC patients carrying specific molecular alterations. There is a great unmet medical need in NSCLC patients with advanced or metastatic disease. Novel approaches using targeted therapeutic agents for these patient populations with molecular characterization could potentially identify subsets of advanced NSCLC patients who would benefit from targeted kinase inhibition. Study treatments, BYL719, INC280, LDK378 and MEK162, which target PIK3CA, c-MET, ALK/ROS1 and MEK respectively, have shown promising data in either preclinical or clinical lung cancer settings.
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 |
|---|---|---|---|
| Adenocarcinoma Lung Cancer; Squamous Cell Lung Carcinoma | Lung Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BYL719 | Drug | Alpelisib | ALIAS |
| INC280 | Drug | Capmatinib | ALIAS |
| LDK378 | Drug | Ceritinib | ALIAS |
| MEK162 | Drug | Binimetinib | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- BYL719 350 mg QD
- description
- Patient's tumor must have molecular alteration of the PIK3CA gene.
- interventionNames
- Drug: BYL719
- type
- EXPERIMENTAL
- label
- INC280 400 mg BID tab/600 mg BID cap
- description
- Patient's tumor must have molecular alteration of the c-MET gene.
- interventionNames
- Drug: INC280
- type
- EXPERIMENTAL
- label
- LDK378 750 mg QD
- description
- Patient's tumor must have ALK or ROS1 gene rearrangement.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced (stage IIIB or stage IV) NSCLC * Must have specific molecular alterations Exclusion Criteria: * Symptomatic central nervous system (CNS) metastases which are neurologically unstable or requiring increasing doses of steroids within the 4 weeks prior to study entry to control their CNS disease * Radiation therapy within ≤ 4 weeks prior to study entry, with the exception of limited field palliative radiotherapy for bone pain relief. * Any other malignancies within the last 5 years before study entry * Major surgery ≤ 2 weeks prior to study entry or who have not recovered from side effects of such therapy
References
Publications (0)
Data not yet available