Clinical trial · Interventional
Study of Alkotinib in Patients With Advanced Non Small Cell Lung Cancer
A Phase I Tolerance, Safety and Efficacy Study of Alkotinib in Patients With Advanced ALK Positive /ROS1 Positive NSCLC and Previously Treated With Chemotherapy or Crizotinib
NCT03607188CI-TRIAL-00074759NSCLCcompletedPhase 1ClinicalTrials.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)
To explore the DLT of ZG0418 for Patients with Advanced ALK+ or ROS1+ NSCLC And Previously Treated with Chemotherapy or Crizotinib, and to determine the MTD or the R2PD.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alkotinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- ZG0418 200mg QD
- description
- ZG0418 200mg/day,oral
- interventionNames
- Drug: Alkotinib
- type
- EXPERIMENTAL
- label
- ZG0418 300mg QD
- description
- ZG0418 300mg/day,oral
- interventionNames
- Drug: Alkotinib
- type
- EXPERIMENTAL
- label
- ZG0418 400mg QD
- description
- ZG0418 400mg/day,oral
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria:
1. Advanced ALK+ or ROS1+ NSCLC And Previously Treated with Chemotherapy or Crizotinib
2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 2.
3. Life expectancy of at least 12 weeks.
4. Ability to swallow and retain oral medication.
5. Adequate organ system function, defined as follows:
1. Absolute neutrophil count (ANC) ≥1.5 x 10\^9/L
2. Platelets ≥75 x 10\^9/L
3. Hemoglobin ≥9 g/dL (≥90 g/L) Note that transfusions are allowed to meet the required hemoglobin level
4. Total bilirubin ≤1.5 times the upper limit of normal (ULN)
5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
≤2.5 x ULN if no liver involvement or ≤5 x ULN with liver involvement.
6. Creatinine 1.5 x ULN.
6. Brain metastases allowed if asymptomatic at study baseline.
7. Patients must have measurable disease per RECIST v. 1.1.
Exclusion Criteria:
1. chemotherapy, radiation therapy, immunotherapy within 4 weeks.
2. Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications.
3. uncontrolled mass of pleural effusion, pericardial effusion, and peritoneal effusion.References
Publications (0)
Data not yet available
No reference posted for this study.