Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancer with RET Fusion-positive
Conditions
Interventions
Vandetanib at 300 mg using 3 x vandetanib tablets 100 mg will be dosed orally, once daily.
Sponsors
National Cancer Center Hospital East
AstraZeneca/Sanofi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Female or male aged 20 years and over 3. Histologically or cytologically confirmation of non-squamous NSCLC 4. Unresectable locally advanced or metastatic disease 5. Positive for RET fusion determined by tumor sample 6. EGFR mutation negative 7. ALK fusion negative 8. Progressive of NSCLC after at least one prior chemotherapy regimen 9. Life expectancy of 3 months or longer 10. ECOG Performance status 0-2 11. Negative pregnancy test for female patients of childbearing potential 12. One or more measurable disease by RECIST 13. Adequate bone marrow function
Exclusion criteria
Exclusion criteria: 1. The last dose of prior chemotherapy or other anti-cancer therapy is discontinued less than 4 weeks before the start of study therapy 2. The last radiation therapy within 4 weeks before the start of study therapy 3. Major surgery within 4 weeks before the start of study therapy, or incompletely healed surgical incision 4. Any unresolved toxicity > CTCAE grade 2 from previous anti-cancer therapy 5. Significant cardiac event, superior vena cava syndrome, New York Heart Association classification of heart disease &#8805;2, within 12 weeks before registration 6. History of arrhythmia, which is symptomatic or requires treatment (CTCAE grade 3) 7. Congenital long QTc syndrome 8. QTc prolongation with other medications that required discontinuation of that medication 9. Potassium concentration <4.0 mEq/L, calcium or magnesium concentrations outside of normal limits at each site despite supplementation 10. Currently pregnant or breast feeding 11. Any concomitant medications that have been associated with Torsades de Pointes or strong inducers of CYP3A4 function within 2 weeks of start of study treatment. 12. Unstable brain metastases or spinal cord compression that requires treatment 13. Hypertension not controlled by medical therapy 14. Previous or current malignancies of other histologies within the last 5 years 15. Evidence of severe or uncontrolled systemic disease 16. Any evidence of clinically active interstitial lung disease 17. Previous exposure to vandetanib
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome variable-ORR | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events PFS DCR Duration of response OS The efficacy of cytotoxic chemotherapy for RET fusion-positive NSCLC will be reported using the previous or post treatment data | — |
Countries
Japan
Contacts
Public ContactKiyotaka Yoh
National Cancer Center Hospital East Division of Thoracic Oncology
Outcome results
None listed