Clinical trial · Interventional
Alkotinib Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib
A Phase II, Multicenter, Single-arm Study to Evaluate Safety and Efficacy of Alkotinib Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib
NCT04211922CI-TRIAL-00076516terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor R\&D Strategy Adjustment
Summary
Brief summary (as posted)
The main purpose of the study is to evaluate safety and efficacy of Alkotinib capsule in patients with ALK-positive non-small cell lung cancer previously treated with crizotinib.While exploring the relationship between biomarkers and drug efficacy and safety.
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 |
|---|---|---|---|
| ALK-positive Non-small Cell Lung Cancer | ALK-Positive Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alkotinib Capsules | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Alkotinib 400mg QD
- description
- 400mg orally once daily. Take Alkotinib at least 1 hour before or at least 2 hours after a meal.
- interventionNames
- Drug: Alkotinib Capsules
Primary outcomes (1)
- measure
- Objective response rate (ORR) based on independent radiology review
- timeFrame
- 24 months
- description
- ORR per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR).
Secondary outcomes (2)
- measure
- Progression-free survival (PFS) as assessed by independent radiology review and investigator
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Evidence of positive ALK. * Patients must have demonstrated progression during or after crizotinib treatment. * Age 18 years or older at the time of informed consent. * Eastern cooperative oncology group performance status (ECOG PS) of 0-2 * At least one measurable lesion by response evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1). * Willingness and ability to comply with the trial and follow-up procedures. Exclusion Criteria: * chemotherapy, radiation therapy, immunotherapy within 4 weeks. * Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications. * Uncontrolled mass of pleural effusion, pericardial effusion, and peritoneal effusion
References
Publications (0)
Data not yet available
No reference posted for this study.