A Phase II Study of HMPL-504 in Lung Sarcomatoid Carcinoma and Other Non-small Cell Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02897479|
Recruitment Status : Active, not recruiting
First Posted : September 13, 2016
Last Update Posted : November 30, 2021
|Condition or disease||Intervention/treatment||Phase|
|Lung Sarcomatoid Carcinoma||Drug: Savolitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Open-label Study to Evaluate the Efficacy and Safety of HMPL-504 in Locally Advanced/Metastatic MET-Mutation-Positive Pulmonary Sarcomatoid Carcinomas and Other Non-small Cell Lung Cancer|
|Actual Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 30, 2021|
|Estimated Study Completion Date :||December 30, 2021|
Pulmonary Sarcomatoid Carcinomas
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.
Other Name: hmpl-504
- To assess objective response rate (ORR) [ Time Frame: 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
- Progression free survival(PFS) [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02897479
|Beijing Cancer Hopspital|
|Beijing, Beijing, China|
|Shanghai Chest Hospital|
|Shanghai, Shanghai, China, 210000|
|Principal Investigator:||Shun LU, doctor||Shanghai Chest Hospital|