A Phase II Study of HMPL-504 in Lung Sarcomatoid Carcinoma and Other Non-small Cell Lung Cancer

Phase 2

• Conditions: Lung Sarcomatoid Carcinoma
• Interventions: Drug: Savolitinib

• Registration Number: NCT02897479
• Lead Sponsor: Hutchison Medipharma Limited

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.

Study Timeline

• Study First Submitted: 2016-08-29
• Study First Submitted QC: 2016-09-07
• Study First Posted: 2016-09-13
• Study Start: 2016-12
• Status Verified: 2021-08
• Last Update Submitted: 2021-11-29
• Last Update Posted: 2021-11-30
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Savolitinib	Savolitinib	Pulmonary Sarcomatoid Carcinomas

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China

Beijing Cancer Hopspital; 🇨🇳 Beijing, Beijing, China