Non-Small Cell Lung CancerPhase 3NCT06110663

A Study of HS-10241 Combined With Almonertinib Versus Platinum-based Chemotherapy in Treatment of Advanced NSCLC With MET Amplification After Failure of EGFR-TKI Therapy

A Phase 3 study testing HS-10241+ Almonertinib and Pemetrexed + Cisplatin /Carboplatin in people with Non-Small Cell Lung Cancer, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

HS-10241, an oral and highly selective MET-TKI, may contribute to overcoming common acquired MET-based resistance mechanisms following prior EGFR-TKI monotherapy. This study is conducted to evaluate the efficacy and safety of HS-10241 combined with Almonertinib versus platinum-based chemotherapy in NSCLC with MET… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Small Cell Lung Cancer
What is being tested?: HS-10241+ Almonertinib and Pemetrexed + Cisplatin /Carboplatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 314 participants
Where: No sites listed yet
Study dates: 30 Dec 2023to 28 Feb 2025
Phase: Phase 3
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

Men or women aged more than or equal to (≥) 18 years.
Patients histologically or cytologically confirmed with locally advanced or metastatic NSCLC.
Patients have previously received EGFR TKI treatment and had intolerance or disease progression by imaging recorded. Chemotherapy as systematic therapy is limited to no more than one prior line. Before randomization, all patients must provide imaging evidence of disease progression during or after the last treatment period. The patients are required to provide tumor biopsy tissue (required) and blood samples (optional) of disease progression after the last treatment of EGFR TKI, confirmed by central laboratory that there are EGFR sensitive mutations (deletion of exon 19 or L858R mutation) and T790M status (negative or positive) in tumor tissues and/or blood samples. Meanwhile, the tumor tissue should be c-MET positive confirmed by the central laboratory.
According to Recist1.1, at least 1 target lesion that should be measurable lesions without local treatment like irradiation or with definite progression after local treatment and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15mm)
ECOG performance status of 0-1with no deterioration within 2 weeks before enrollment.
Estimated life expectancy ≥three months.

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Females of child bearing age should adapt adequate contraceptive measures and should not be breastfeeding from the signing of informed consent to 6 months after the last treatment of the study. Male patients should be willing to use barrier contraception (i.e., condoms) from the signing of informed consent to 6 months after the last treatment of the study.
Females must have a negative pregnancy test in 7 days prior to the date of randomization if of childbearing potential or must have evidence of non-childbearing potential by fulfilling any one of the criteria.
Signed and dated Informed Consent Form.

Who cannot join

Treatment with any of the following:
Previous or current treatment with drugs targeting the c-MET/HGF pathway.
Previous or under treatment with pemetrexed and platinum.
Any cytotoxic chemotherapy, investigational agents, antitumor traditional Chinese Medicine and any other anticancer drugs for the treatment of advanced NSCLC within 14 days before the date of randomization; or requiring treatment with these drugs during the study.
Any antitumor monoclonal antibody therapy within 28 days before the date of randomization.
Local radiotherapy within 2 weeks of the date of randomization; receiving radiation to > 30% of the bone marrow or with a wide field of radiation within 4 weeks before the date of randomization.

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Spinal cord compression or brain metastases (except for that being asymptomatic and stable for at least 4 weeks, not requiring steroids for at least 2 weeks prior to start of study treatment and with no obvious edema around the tumor focus by imaging examination).
Currently receiving drugs known to prolong QT interval or may cause torsade de pointe; or requiring treatment with these drugs during the study.
Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 with the exception of alopecia or neurotoxicity.
History of other primary malignancies.
Inadequate bone marrow reserve or organ function, as demonstrated by any of the following laboratory values:
Absolute neutrophil count (ANC) <1.5×109 / L
Platelet count <90×109 / L
Hemoglobin <90 g/L
Total bilirubin (TBL) > 1.5 × ULN or > 3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases.
One or both of Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) > 2.5 × upper limit of normal (ULN) or > 5 × ULN in the presence of liver metastases.
Creatinine > 1.5 × ULN concurrent with creatinine clearance < 50 mL/min; confirmation of creatinine clearance is only required when creatinine is > 1.5 × ULN.
International normalized ratio (INR) > 1.5, and partially activated prothrombin time (APTT) > 1.5 × ULN.
Serum albumin (ALB) < 28 g/L
Any of the following cardiac criteria:
Resting corrected QT interval (QTc) > 470 ms obtained from electrocardiogram (ECG), using the screening clinic's ECG machine and Fridericia's formula for QT interval correction (QTcF).
Left ventricular ejection fraction (LVEF) ≤ 50%.
Severe, uncontrolled or active cardiovascular diseases.
Diabetes ketoacidosis or hyperglycemia hypertonic occurring within 6 months before the date of randomization, or the glycosylated hemoglobin value ≥ 7.5% in the screening period.
Severe or poorly controlled hypertension.
Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Grade B or more severe cirrhosis.
Other moderate or severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity or may seriously affect respiratory function.
Women who are breastfeeding or pregnant or planned to be pregnant during the study period.
History of hypersensitivity to any active or inactive ingredient of HS-10241/Almonertinib/ cisplatin/carboplatin/pemetrexed or to drugs with a similar chemical structure or class to HS-10241/Almonertinib/cisplatin/carboplatin/pemetrexed.
Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
Any disease or condition that, in the opinion of the investigator, would compromise the safety of the patient or interfere with study assessments.

About this study

Official title: A Phase 3, Randomized, Open-label, Multicenter Study to Assess the Efficacy and Safety of HS-10241 Combined With Almonertinib Versus Pemetrexed Combined With Platinum in Metastatic or Locally Advanced NSCLC With MET Amplification After Failure of the Prior EGFR -TKI Therapy

Read the detailed description

This is a phase 3, randomized, open-label, multicenter study to evaluate the efficacy and safety of HS-10241 in combination with Almonertinib versus platinum-based chemotherapy in patients with MET-amplified locally advanced or metastatic NSCLC who have progressed after prior EGFR-TKI therapy.

All eligible patients were randomly assigned to experimental group (HS-10241 combined with Almonertinib) or control group (pemetrexed combined with platinum) at a ratio of 1:1. Patients in experimental group will receive HS-10241 300mg twice daily (BID) combined with Almonertinib 110mg once daily (QD) orally and will continue treatment until disease progression or other criteria for treatment discontinuation will be met. Patients in control group will receive the standard chemotherapy treatment of cisplatin/carboplatin combined with pemetrexed for 4~6 cycles. Participants will continue receive pemetrexed monotherapy until disease progression or other criteria for treatment discontinuation will be met. The efficacy and safety of the two groups will be evaluated after follow-up.

Conditions: Non-Small Cell Lung Cancer
Being tested: HS-10241+ Almonertinib, Pemetrexed + Cisplatin /Carboplatin
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HS-10241+ AlmonertinibDrug
HS-10241 300mg twice daily (BID) combined with Almonertinib 110mg once daily (QD) orally, for every cycle of 21 days until disease progression or other criteria for treatment discontinuation will be met.
Pemetrexed + Cisplatin /CarboplatinDrug
The standard chemotherapy treatment of cisplatin/carboplatin combined with pemetrexed for 4~6 cycles (every 3 weeks).
Participants will continue receive pemetrexed monotherapy until disease progression or other criteria for treatment discontinuation will be met.

Study groups in NCT06110663
Study group	Role	What they receive
HS-10241+Almonertinib	Experimental	Experimental group (Experimental): HS-10241 combined with Almonertinib NSCLC with MET amplification after failure of EGFR-TKI treatment randomized to HS-10241 combined with Almonertinib Receives: Drug: HS-10241+ Almonertinib
Pemetrexed + Cisplatin /Carboplatin	Active comparator	Control group (Active Comparator): Pemetrexed combined with Platinum NSCLC with MET amplification after failure of EGFR-TKI treatment randomized to standard chemotherapy treatment of platinum-based chemotherapy Receives: Drug: Pemetrexed + Cisplatin /Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-free Survival (PFS) evaluated by Independent Review Committee (IRC)
Progression of tumor was assessed by RECIST 1.1 thereby to evaluate progression free survival. Progression-free survival was deﬁned as the time from date of randomization until the documentation of objective disease progression (PD) or death from any cause in the absence of progression (whichever occurred first), regardless of whether they subsequently received non-study anti-cancer therapy.
Measured: From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, assessed up to 24 months

Secondary outcomes (5)

Objective response rate (ORR) evaluated by Independent Review Committee (IRC)
ORR was defined as the percentage of patients with a complete response (CR) or partial response (PR) that was confirmed at a subsequent scan at least 4 weeks later, as assessed according to RECIST version 1.1
Measured: From the date of randomization to disease progression or date of death from any cause, whichever comes first, assessed up to 24 months.
Disease control rate (DCR) evaluated by Independent Review Committee (IRC)
Objective response was assessed by RECIST 1.1 thereby to evaluate disease control rate. Disease control was deﬁned as the percentage of patients who have a best overall response (confirmed CR, PR, or stable disease for at least 5 weeks)
Measured: From the date of randomization to disease progression or date of death from any cause, whichever comes first, assessed up to 24 months.
Duration of response (DoR) evaluated by Independent Review Committee (IRC)
Duration of response assessed by RECIST 1.1. Duration of response was defined as the time from when the criteria for CR or PR were first met to the occurrence of an objective disease progression (PD) or death.
Measured: From the date of randomization to disease progression or date of death from any cause, whichever comes first, assessed up to 24 months.
Overall survival (OS)
OS was defined as time from randomization until the date of death due to any cause.
Measured: From the date of randomization up to the date of date of death from any cause，assessed up to 24 months.
Incidence and severity of treatment-emergent adverse events
Assessed by number and severity of adverse events as recorded on the case report form NCI CTCAE v5.0.
Measured: From the date of randomization until 28 days after the last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Dec 202328 Feb 2025

First posted1 Nov 2023
Study start30 Dec 2023 (estimated)
Primary completion30 Dec 2024 (estimated)
Study completion28 Feb 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 314 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06110663
Sponsor's protocol ID: HS-10241-301
Status last verified: Oct 2023
First submitted: 24 Oct 2023
Last updated: 1 Nov 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Open-label, Multicenter Study to Assess the Efficacy and Safety of HS-10241 Combined With Almonertinib Versus Pemetrexed Combined With Platinum in Metastatic or Locally Advanced NSCLC With MET Amplification After Failure of the Prior EGFR -TKI Therapy
ClinicalTrials.gov ID: NCT06110663
Acronym / sponsor ID: HS-10241-301
Conditions: Non-Small Cell Lung Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 314 participants (estimated)
Lead sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 30 Dec 2023 (estimated)
Primary completion: 30 Dec 2024 (estimated)
Study completion: 28 Feb 2025 (estimated)
First posted: 1 Nov 2023 (actual)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
HS-10241+Almonertinib	Experimental	Drug: HS-10241+ AlmonertinibExperimental group (Experimental): HS-10241 combined with Almonertinib NSCLC with MET amplification after failure of EGFR-TKI treatment randomized to HS-10241 combined with Almonertinib
Pemetrexed + Cisplatin /Carboplatin	Active comparator	Drug: Pemetrexed + Cisplatin /CarboplatinControl group (Active Comparator): Pemetrexed combined with Platinum NSCLC with MET amplification after failure of EGFR-TKI treatment randomized to standard chemotherapy treatment of platinum-based chemotherapy

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Men or women aged more than or equal to (≥) 18 years.
Patients histologically or cytologically confirmed with locally advanced or metastatic NSCLC.
Patients have previously received EGFR TKI treatment and had intolerance or disease progression by imaging recorded. Chemotherapy as systematic therapy is limited to no more than one prior line. Before randomization, all patients must provide imaging evidence of disease progression during or after the last treatment period. The patients are required to provide tumor biopsy tissue (required) and blood samples (optional) of disease progression after the last treatment of EGFR TKI, confirmed by central laboratory that there are EGFR sensitive mutations (deletion of exon 19 or L858R mutation) and T790M status (negative or positive) in tumor tissues and/or blood samples. Meanwhile, the tumor tissue should be c-MET positive confirmed by the central laboratory.
According to Recist1.1, at least 1 target lesion that should be measurable lesions without local treatment like irradiation or with definite progression after local treatment and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15mm)
ECOG performance status of 0-1with no deterioration within 2 weeks before enrollment.

Key exclusion criteria (31 listed)

Treatment with any of the following:
Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 with the exception of alopecia or neurotoxicity.
History of other primary malignancies.
Inadequate bone marrow reserve or organ function, as demonstrated by any of the following laboratory values:
Any of the following cardiac criteria:

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
HS-10241+ AlmonertinibHS-10241 300mg twice daily (BID) combined with Almonertinib 110mg once daily (QD) orally, for every cycle of 21 days until disease progression or other criteria for treatment discontinuation will be met.	Drug	HS-10241+Almonertinib
Pemetrexed + Cisplatin /CarboplatinThe standard chemotherapy treatment of cisplatin/carboplatin combined with pemetrexed for 4~6 cycles (every 3 weeks). Participants will continue receive pemetrexed monotherapy until disease progression or other criteria for treatment discontinuation will be met.	Drug	Pemetrexed + Cisplatin /Carboplatin

Primary outcome

Progression-free Survival (PFS) evaluated by Independent Review Committee (IRC)
Time frame: From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, assessed up to 24 months
Progression of tumor was assessed by RECIST 1.1 thereby to evaluate progression free survival. Progression-free survival was deﬁned as the time from date of randomization until the documentation of objective disease progression (PD) or death from any cause in the absence of progression (whichever occurred first), regardless of whether they subsequently received non-study anti-cancer therapy.

5 secondary outcomes

Objective response rate (ORR) evaluated by Independent Review Committee (IRC)
Time frame: From the date of randomization to disease progression or date of death from any cause, whichever comes first, assessed up to 24 months.
Disease control rate (DCR) evaluated by Independent Review Committee (IRC)
Time frame: From the date of randomization to disease progression or date of death from any cause, whichever comes first, assessed up to 24 months.
Duration of response (DoR) evaluated by Independent Review Committee (IRC)
Time frame: From the date of randomization to disease progression or date of death from any cause, whichever comes first, assessed up to 24 months.
Overall survival (OS)
Time frame: From the date of randomization up to the date of date of death from any cause，assessed up to 24 months.
Incidence and severity of treatment-emergent adverse events
Time frame: From the date of randomization until 28 days after the last dose

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.

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RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
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A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HS-10241+ Almonertinib and Pemetrexed + Cisplatin /Carboplatin in people with Non-Small Cell Lung Cancer, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..

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 9 inclusion and 31 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 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Progression-free Survival (PFS) evaluated by Independent Review Committee (IRC) (time frame: From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, assessed up to 24 months). 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 NCT06110663.

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 1 Nov 2023.