Clinical trial · Interventional
Study of Apatinib in RET Fusion Positive Advanced Non-small Cell Lung Cancer
A Phase II Clinical Trial to Investigate Efficacy and Safety of Apatinib as a Single Agent in RET-fusion Gene Positive Non-small Cell Lung Cancer Who Failed to Previous Treatment.
- 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)
RET fusions are present in 1% to 2% of unselected population of non-small cell lung cancer (NSCLC). Existing US Food and Drug Administration-approved inhibitors of RET tyrosine kinase show promising therapeutic effects in a non-small cell lung cancer patients. Apatinib is an oral multi-kinase inhibitors including RET fusions. This study is designed to evaluate the safety and tolerability of Apatinib in patients with RET fusion positive advanced 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib single agent arm | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Apatinib single agent arm
- description
- Apatinib, single agent, 750mg once daily p.o until disease progression
- interventionNames
- Drug: Apatinib single agent arm
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- change from baseline in tumor size every 6-8 weeks after the initiation of apatinib, up to 24 months
- description
- To evaluate ORR every 6-8 weeks after initiation of apatinib
Secondary outcomes (4)
- measure
- Progression Free Survival (PFS)
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Aged ≥18 and ≤80 years. * ECOG performance status of 0 to 1. * Life expectancy of more than 12 weeks. * At least one measurable lesion exists.(RECIST 1.1) * Histologically or cytologic confirmed RET fusion positive advanced Non-small cell lung cancer who failed to prior therapies. * Required laboratory values including following parameters: ANC: ≥ 1.5 x 10\^9/L, Platelet count: ≥ 80 x 10\^9/L, Hemoglobin: ≥ 90 g/L, Total bilirubin: ≤ 1.5 x upper limit of normal, ULN, ALT and AST: ≤ 1.5 x ULN, BUN and creatine clearance rate: ≥ 50 mL/min LVEF: ≥ 50% QTcF: \< 470 ms * Signed informed consent * Females of child-bearing potential must have negative serum pregnancy test. Sexually active male and those having childbearing potential must practice contraception during the study. Exclusion Criteria: * Squamous carcinoma (including adeno-squamous carcinoma), small cell lung cancer * Subjects with third space fluid that can not be controled by drainage or other methods. * Obvious cavity or necrosis formed in the tumor * Uncontrolled hypertension * Hymoptysis, more than 2.5ml daily * Thrombosis in 12 months, including pulmonary thrombosis, stroke, or deep venous thrombosis * Received big surgery, had bone fracture or ulcer in 4 weeks * Urine protein \>++, or urine protein in 24 hours\> 1.0g * pregnant or lactating woman * Receiving any other antitumor therapy. * Known history of hypersensitivity to apatinib or any of it components.
References
Publications (0)
Data not yet available