Lung cancer
Conditions
Interventions
treatment group:Pemigatinib
Sponsors
Chinese People's Liberation Army General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years old; 2. Advanced, recurrent or metastatic lung cancer and advanced urothelial carcinoma confirmed by histology or cytology to be unresectable by surgery; 3. At least one measurable lesion according to RECIST v1.1; 4. Histologically confirmed FGFR alterations, including but not limited to amplification, mutation, fusion/rearrangement, etc.; 5. Disease progression after >=1 line of standard treatment; EGFR/ALK/ROS1 positive non-small cell lung cancer requires EGFR/ALK/ROS1 inhibitor treatment after failure, regardless of whether they have received chemotherapy (without chemotherapy, subject to rejection or Patients with EGFR/ALK/ROS1-negative non-small cell lung cancer who are not suitable for chemotherapy) can be enrolled; patients with EGFR/ALK/ROS1-negative non-small cell lung cancer need to undergo at least first-line platinum-containing chemotherapy and PD1/PDL1 inhibitor treatment failure; Patients with small cell lung cancer need to have failed at least first-line platinum-containing chemotherapy or PD1/PDL inhibitor treatment; urothelial carcinoma needs to have received at least first-line chemotherapy or PD1/PDL1 inhibitor treatment failure; 6. ECOG fitness status is 0-1; 7. Expected survival time > 3 months; 8. Adequate organ function.
Exclusion criteria
Exclusion criteria: 1. Diagnosed with other malignant diseases other than lung cancer or urothelial cancer within 5 years before the first administration; 2. Known symptomatic CNS metastases and/or cancerous meningitis; 3. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 4. Abnormal laboratory parameters: serum phosphate > ULN; serum calcium outside the normal range, or serum albumin-corrected calcium concentration outside the normal range when serum albumin is outside the normal range; potassium level < lower limit of normal; at screening Potassium levels can be corrected with supplements; 5. Clinically significant or uncontrolled heart disease, uncontrolled hypertension, hepatic encephalopathy, hepatorenal syndrome or Child-Pugh grade B or more severe liver cirrhosis; 6. History of calcium and phosphorus metabolism disorder or systemic electrolyte metabolism imbalance with ectopic calcification of soft tissue; 7. Clinically significant corneal or retinal disease confirmed by ophthalmological examination; 8. Have used any strong CYP3A4 inhibitor or inducer within 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug. Topical ketoconazole is allowed; 9. Unable or unwilling to swallow pemigatinib or have significant digestive system diseases that may interfere with absorption, metabolism or excretion; 10. The subject has a history of vitamin D deficiency and needs to supplement vitamin D at a supraphysiological dose (except vitamin D dietary supplements).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Countries
China
Contacts
Public ContactHu Yi
Department of Medical Oncology, Chinese People's Liberation Army General Hospital
Outcome results
None listed