Lung Sarcomatoid Carcinoma
Conditions
Brief summary
This is a Phase II, open-label, multicenter study of Savolitinib administered orally once per day(QD) to locally advanced/metastatic PSC patients and other NSCLC patients with MET Exon 14 mutation. The targeted population is the patients with MET Exon 14 mutation who have failed prior systemic therapy (ies), or are unwilling or can not tolerate to receive chemotherapy. Pathological diagnosis will be confirmed retrospectively by the central pathological laboratory.
Detailed description
Savolitinib will be administrated 600mg or 400mg once per day (QD). The treatment will be discontinued for the patients who experience disease progression, death or experience unacceptable toxicity, whichever occurs first. A cycle of study treatment will be defined as 21 days of continuous dosing.
Interventions
DRUGSavolitinib
Enrolled patients will be treated with Savolitinib 600mg or 400mg once per day(QD), till disease progression, death or unacceptable toxicity, whichever comes first. A cycle of study treatment will be defined as 21 days of continuous dosing.
Sponsors
Hutchison Medipharma Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1.Fully understood the study and voluntarily signed Informed Consent Form * 2.Age \> 18 years * 3.Histologically or cytologically documented locally advanced or Metastatic pulmonary sarcomatoid carcinoma (PSC) patients and other Non-small cell lung cancer（NSCLC） with MET Exon 14 mutation who have failed piror systemic therapy(ies), or are unwilling or unable to receive chemotherapy * 4.Patient should have measurable disease per RECIST1.1 * 5.ECOG performance status of 0, or 1 * 6.Expected survival \> 12 weeks
Exclusion criteria
* 1.Co-existing malignancy or malignancies diagnosed within the last 3 years other than lung cancer with the exception of adequately treated skin basal cell carcinoma or cervical cancer in situ. * 2.Any anti-cancer therapy, including chemotherapy, hormonal therapy, biologic therapy or radiotherapy within 3weeks prior to initiation of study treatment, or received TKI (for ex. EGFR-TKI) treatment within 2 week prior to initiation of study treatment * 3.Palliative radiation to bone metastases within 2 weeks prior to the initiation of study treatment * 4.Herbal therapy within 1 week prior to the initiation of study treatment * 5\. has EGFR, ALK or ROS 1 positive mutation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess objective response rate (ORR) | 1year | ORR is defined as the proportion of patients with complete response or partial response. The confirmation of response for patients who has PR or CR at first time should be performed by at least 4 weeks and in this study, it could be performed by the scheduled tumor assessment 6 weeks later |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival(PFS) | 1year | PFS is defined as the Progression free surviva of patients with complete response or partial response or stable disease. In the case of SD, measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks. |
| Safety Assessment Parameter | 1year | The safety will be assessed using the following safety outcome measures: incidence of adverse events, physical examinations,vital signs and laboratory tests (including hematology, clinical chemistry, urine tests and other indicators)12-ECG parameters and echocardiogram. |
Countries
China
Outcome results
None listed