Lung Sarcomatoid CarcinomaPhase 2NCT02897479
A Phase II Study of HMPL-504 in Lung Sarcomatoid Carcinoma and Other Non-small Cell Lung Cancer
A Phase 2 study testing Savolitinib in people with Lung Sarcomatoid Carcinoma, run by Hutchison Medipharma Limited at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Sarcomatoid Carcinoma
- What is being tested?
- Savolitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 2 sitesChina
- Study dates
- Dec 2016to 30 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Cancer Hopspital
Beijing, Beijing Municipality
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 210000
About this study
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
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.
Read the 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.
- Conditions
- Lung Sarcomatoid Carcinoma
- Being tested
- Savolitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SavolitinibDrug
Also called hmpl-504
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.
| Study group | Role | What they receive |
|---|---|---|
| Savolitinib | Experimental | Pulmonary Sarcomatoid Carcinomas Receives: Drug: Savolitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1year
Secondary outcomes (2)
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.
Measured: 1year
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.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startDec 2016
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung Sarcomatoid CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hutchison Medipharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shun LU, doctor, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897479
- Sponsor's protocol ID
- 2016-504-00CH1
- Status last verified
- Aug 2021
- First submitted
- 29 Aug 2016
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 36339926Paik 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.
PubMed 35543963Lu 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.
PubMed 34166627
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02897479
- Acronym / sponsor ID
- 2016-504-00CH1
- Conditions
- Lung Sarcomatoid Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Hutchison Medipharma LimitedIndustry (pharma, biotech, devices)
- Study start
- Dec 2016 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 13 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Savolitinib | Experimental | Drug: SavolitinibPulmonary Sarcomatoid Carcinomas |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SavolitinibAlso: hmpl-504Enrolled 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. | Drug | Savolitinib |
Primary outcome
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
2 secondary outcomes
Progression free survival(PFS)
Time frame: 1year
Safety Assessment Parameter
Time frame: 1year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Derived from this study: PubMed 36339926Yu 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.
- Derived from this study: PubMed 35543963Paik 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.
- Derived from this study: PubMed 34166627Lu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shun LU, doctor principal investigator
Shanghai Chest Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Savolitinib in people with Lung Sarcomatoid Carcinoma, run by Hutchison Medipharma Limited at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess objective response rate (ORR) (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02897479, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.