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

NCT02897479 | Unknown Phase 2

• 1 other identifier: 2016-504-00CH1
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Sarcomatoid Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

  1year

Secondary Outcomes (2)

• Progression free survival(PFS)

  1year

• Safety Assessment Parameter

  1year

Study Arms (1)

Savolitinib

EXPERIMENTAL

Pulmonary Sarcomatoid Carcinomas

Drug: Savolitinib

Interventions

Savolitinib DRUG

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.

Also known as: hmpl-504

Savolitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fully understood the study and voluntarily signed Informed Consent Form
• Age \> 18 years
• 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
• Patient should have measurable disease per RECIST1.1
• ECOG performance status of 0, or 1
• Expected survival \> 12 weeks

You may not qualify if:

• 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.
• 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
• Palliative radiation to bone metastases within 2 weeks prior to the initiation of study treatment
• Herbal therapy within 1 week prior to the initiation of study treatment
• \. has EGFR, ALK or ROS 1 positive mutation

Sponsors & Collaborators

• Hutchison Medipharma Limited: lead

Study Sites (2)

Beijing Cancer Hopspital

Beijing, Beijing Municipality, China

Location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 210000, China

Location

Related Publications (3)

• 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.

  PMID: 36339926 DERIVED

• 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.

  PMID: 35543963 DERIVED

• 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.

  PMID: 34166627 DERIVED

MeSH Terms

Interventions

1-(1-(imidazo(1,2-a)pyridin-6-yl)ethyl)-6-(1-methyl-1H-pyrazol-4-yl)-1H-(1,2,3)triazolo(4,5-b)pyrazine

Study Officials

• Shun LU, doctor

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 13, 2016
• Study Start: December 1, 2016
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: November 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)