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

Primary Purpose

Lung Sarcomatoid Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Savolitinib

About this trial

This is an interventional treatment trial for Lung Sarcomatoid Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Beijing Cancer Hopspital
Shanghai Chest Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Savolitinib

Arm Description

Pulmonary Sarcomatoid Carcinomas

Outcomes

Primary Outcome Measures

To assess objective response rate (ORR)

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

Progression free survival(PFS)

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

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.

Full Information

NCT ID

NCT02897479

First Posted

August 29, 2016

Last Updated

November 29, 2021

Sponsor

Hutchison Medipharma Limited

1. Study Identification

Unique Protocol Identification Number

NCT02897479

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

December 2016 (Actual)

Primary Completion Date

December 30, 2021 (Anticipated)

Study Completion Date

December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hutchison Medipharma Limited

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Sarcomatoid Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Savolitinib

Arm Type

Experimental

Arm Description

Pulmonary Sarcomatoid Carcinomas

Intervention Type

Drug

Intervention Name(s)

Savolitinib

Other Intervention Name(s)

hmpl-504

Intervention Description

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.

Primary Outcome Measure Information:

Title

To assess objective response rate (ORR)

Description

Time Frame

1year

Secondary Outcome Measure Information:

Title

Progression free survival(PFS)

Description

Time Frame

1year

Title

Safety Assessment Parameter

Description

Time Frame

1year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shun LU, doctor

Organizational Affiliation

Shanghai Chest Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Cancer Hopspital

City

Beijing

State/Province

Beijing

Country

China

Facility Name

Shanghai Chest Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

210000

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36339926

Citation

Yu Y, Ren Y, Fang J, Cao L, Liang Z, Guo Q, Han S, Ji Z, Wang Y, Sun Y, Chen Y, Li X, Xu H, Zhou J, Jiang L, Cheng Y, Han Z, Shi J, Chen G, Ma R, Fan Y, Sun S, Jiao L, Jia X, Wang L, Lu P, Xu Q, Luo X, Su W, Lu S. Circulating tumour DNA biomarkers in savolitinib-treated patients with non-small cell lung cancer harbouring MET exon 14 skipping alterations: a post hoc analysis of a pivotal phase 2 study. Ther Adv Med Oncol. 2022 Oct 31;14:17588359221133546. doi: 10.1177/17588359221133546. eCollection 2022.

Results Reference

derived

PubMed Identifier

35543963

Citation

Paik PK, Pfeiffer BM, Vioix H, Garcia A, Postma MJ. Matching-Adjusted Indirect Comparison (MAIC) of Tepotinib with Other MET Inhibitors for the Treatment of Advanced NSCLC with MET Exon 14 Skipping Mutations. Adv Ther. 2022 Jul;39(7):3159-3179. doi: 10.1007/s12325-022-02163-9. Epub 2022 May 11.

Results Reference

derived

PubMed Identifier

34166627

Citation

Lu S, Fang J, Li X, Cao L, Zhou J, Guo Q, Liang Z, Cheng Y, Jiang L, Yang N, Han Z, Shi J, Chen Y, Xu H, Zhang H, Chen G, Ma R, Sun S, Fan Y, Li J, Luo X, Wang L, Ren Y, Su W. Once-daily savolitinib in Chinese patients with pulmonary sarcomatoid carcinomas and other non-small-cell lung cancers harbouring MET exon 14 skipping alterations: a multicentre, single-arm, open-label, phase 2 study. Lancet Respir Med. 2021 Oct;9(10):1154-1164. doi: 10.1016/S2213-2600(21)00084-9. Epub 2021 Jun 21.

Results Reference

derived

Learn more about this trial

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

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