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Non-Squamous Non-Small Cell Lung CancerPhase 2/3NCT06417008

A Study of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer

A Phase 2/3 study testing HS-20117 and Aumolertinib in people with Non-Squamous Non-Small Cell Lung Cancer, run by Hansoh BioMedical R&D Company at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

HS-20117 is a fully-human EGFR-MET immunoglobulin G1(IgG1)-like bispecific antibody. The purpose of this study is to assess the safety, efficacy, pharmacokinetics and immunogenicity of HS-20117 combined with Aumolertinib in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions [Exon… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-Squamous Non-Small Cell Lung Cancer
What is being tested?
HS-20117 and Aumolertinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,080 participants
Where
2 sitesChina
Study dates
28 May 2024to 1 Jun 2030
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males or females aged 18 - 75 years (inclusive).
  • Participants with newly diagnosed histologically or cytologically confirmed, locally advanced or metastatic EGFR-sensitive mutated NSCLC (stage IIIB/IIIC/IV) that is treatment naive and not amenable to curative therapy including surgical resection or chemoradiation.
  • Agree to provide fresh or archival tumor tissue.
  • At least one target lesion per the RECIST v1.1.
  • ECOG performance status of 0-1.
  • Minimum life expectancy > 12 weeks.
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  • Males or Females should be using adequate contraceptive measures throughout the study.
  • Females must not be pregnant at screening or have evidence of non-childbearing potential.
  • Have signed Informed Consent Form.

Who cannot join

  • Received or are receiving the following treatments:
  • Previous or current treatment with MET targeted therapy or EGFR targeted antibodies or antibody-drug conjugates (ADC).
  • Traditional Chinese medicine indicated for tumors, major surgery or other local therapy within washout period to the first dose of study drug.
  • Presence of pleural effusion/ascites requiring clinical intervention; presence of pericardial effusion.
  • Other investigational non-anti-tumor drugs, strong CYP3A4 inhibitors, strong inducers, drugs that are sensitive substrates of BCRP or P-gp, or drugs that prolong the QT interval within the washout period.
  • Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.
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  • History of other primary malignancies.
  • Untreated, or active central nervous system metastases.
  • Inadequate bone marrow reserve or organ functions.
  • Severe, uncontrolled or active cardiovascular disorders.
  • Severe or uncontrolled systemic diseases.
  • Severe bleeding symptoms or bleeding tendencies.
  • Severe arteriovenous thrombosis occurred.
  • Serious or active infection.
  • Active infectious diseases.
  • Interstitial lung disease (ILD).
  • Serious neurological or mental disorders.
  • History of hypersensitivity to any component of HS-20117 and Aumolertinib or their similar drugs.
  • Female subjects who are pregnant, lactating, or planning to become pregnant or breastfeed during the study period or within 6 months after the last dose of the study drug.
  • Subjects with a history of severe allergic reactions or those who have experienced severe infusion reactions
  • Participants with any condition that compromises the safety of the participant or interferes with the assessment of the study, as judged by the investigator.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jialei Fu contact

+86 18652105685

fujl@hspharm.com

China2 sites, 2 recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310000

    Yun Fan, M.D., 13858182310, fanyun@zjcc.org.cn

    Recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

    Dingzhi Huang, MD, 18622221232, zlyyfnkdoc@163.com

    Recruiting

Other trials in China

About this study

Official title: A Phase Ib/III Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Immunogenicity of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer

HS-20117 is a fully-human EGFR-MET immunoglobulin G1(IgG1)-like bispecific antibody. The purpose of this study is to assess the safety, efficacy, pharmacokinetics and immunogenicity of HS-20117 combined with Aumolertinib in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions [Exon 19del] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).

Read the detailed description

This is a multicenter Phase Ib/III clinical study evaluating the safety, efficacy, pharmacokinetics (PK), and immunogenicity of HS-20117 in combination with aumolertinib in subjects with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). The study is divided into two phases, Phase Ib, a dose expansion study and Phase III, a confirmatory study. In the dose expansion phase (Phase Ib), HS-20117 will first be studied in combination with the standard dose of aumolertinib, to assess the efficacy, safety, tolerability, PK profile, and immunogenicity of HS-20117 in combination with aumolertinib in the target population, as well as to determine the recommended Phase III dose (RP3D). Following confirmation of the safety and efficacy of HS-20117 in combination with aumolertinib and RP3D in Phase Ib, a randomized, active-controlled, open-label, multicenter Phase III study will be initiated to assess the efficacy and safety of HS-20117 in combination with aumolertinib versus aumolertinib in the target population in the confirmatory study phase.

Being tested
HS-20117, Aumolertinib
Keywords
Non-Small Cell Lung Cancer, HS-20117, Epidermal Growth Factor Receptor, c-Mesenchymal-Epithelial Transition, Bispecific Antibody
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-20117Drug

    Also called PM1080

    Participants will receive HS-20117 once during cycle 1 and once every 2 weeks during subsequent cycles (The duration of each treatment cycle is 28 days)

  • AumolertinibDrug

    Also called Almonertinib Mesilate Tablets, HS-10296, Almonertinib

    110 mg orally once daily.

Study groups in NCT06417008
Study groupRoleWhat they receive
Phase Ib: HS-20117 and AumolertinibExperimentalParticipants will receive IV infusion of HS-20117 once during cycle 1 and once every 2 weeks during subsequent cycles (The duration of each treatment cycle is 28 days) at exploratory doses. Aumolertinib will be administered 110 mg orally once daily.
Receives: Drug: HS-20117; Drug: Aumolertinib
Phase III: HS-20117 and AumolertinibExperimentalParticipants will receive IV infusion of HS-20117 once during cycle 1 and once every 2 weeks during subsequent cycles (The duration of each treatment cycle is 28 days) at exploratory doses. Aumolertinib will be administered 110 mg orally once daily.
Receives: Drug: HS-20117; Drug: Aumolertinib
Phase III: AumolertinibActive comparatorParticipants will receive Aumolertinib 110 mg orally once daily.
Receives: Drug: Aumolertinib

What is being measured

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

  1. [Phase Ib] Objective response rate (ORR) According to response evaluation criteria in solid tumors (RECIST) v1.1 by Investigators (INVs)

    ORR is defined as the percentage of participants with DOR of confirmed CR or confirmed PR per RECIST v1.1

    Measured: From the date of first dose until the date of disease progression or withdrawal from study, up to approximately 40 months

  2. [Phase III] Progression-Free Survival (PFS) According to RECIST v1.1 by Independent Review Committee(IRC)

    PFS is defined as the time from randomization until the date of objective disease progression or death, whichever occurred first, based on IRC using RECIST v1.1

    Measured: Up to approximately 40 months

Secondary outcomes (15)

  1. [Phase Ib and III] Overall Survival (OS)

    Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause.

    Measured: Approximately 60 months

  2. [Phase Ib and III] Disease control rate (DCR) According to RECIST v1.1 by INVs

    DCR is defined as the percentage of patients who have a best overall response (confirmed CR, PR, or stable disease for at least 6 weeks) based on Investigator's assessment per RECIST v1.1.

    Measured: From the date of first dose until the date of disease progression or withdrawal from study, approximately 40 months.

  3. [Phase Ib and III] Duration of response (DoR) According to RECIST v1.1 by INVs

    DoR only applies to participants whose best overall response is CR or PR based on Investigator's assessment per RECIST v1.1. The start date is the date of first documented response of CR or PR (i.e. the start date of observed response, not the date when response was confirmed), and the end date is defined as the date of the first documented progression or death due to underlying disease.

    Measured: From the date of CR, PR until the date of disease progression or death, approximately 40 months.

  4. [Phase Ib and III] Progression-Free Survival (PFS) According to RECIST v1.1 by INVs

    PFS is defined as the time from randomization until the date of objective disease progression or death, whichever occurred first, based on IRC using RECIST v1.1

    Measured: Up to approximately 40 months

  5. [Phase III] ORR According to RECIST v1.1 by INVs

    ORR is defined as the percentage of participants with BOR of CR or PR per RECIST v1.1

    Measured: From the date of first dose until the date of disease progression or withdrawal from study, up to approximately 40 months

  6. [Phase III] ORR According to RECIST v1.1 by IRC

    ORR is defined as the percentage of participants with BOR of CR or PR per RECIST v1.1

    Measured: From the date of first dose until the date of disease progression or withdrawal from study, up to approximately 40 months

  7. [Phase III] DCR According to RECIST v1.1 by IRC

    DCR is defined as the percentage of patients who have a best overall response (confirmed CR, PR, or stable disease for at least 6 weeks)

    Measured: From the date of first dose until the date of disease progression or withdrawal from study, approximately 40 months.

  8. [Phase III] DoR According to RECIST v1.1 by IRC

    DoR only applies to participants whose best overall response is CR or PR. The start date is the date of first documented response of CR or PR (i.e. the start date of observed response, not the date when response was confirmed), and the end date is defined as the date of the first documented progression or death due to underlying disease.

    Measured: From the date of CR, PR until the date of disease progression or death, approximately 40 months.

  9. [Phase Ib and III] Incidence and severity of treatment-emergent adverse events

    Adverse event (assessed according to NCI CTCAE v5.0) is defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

    Measured: From the date of first dose until 90 days after the final dose. A cycle is 28 days.

  10. [Phase Ib and III] Immunogenicity of HS-20117

    Immunogenicity will be measured by the number of participants that are ADA positive.

    Measured: Cycle 1 Day 1: predose through EOT or follow up period (90 days after the last dose).

  11. [Phase Ib] PK parameters: Maximum serum concentration (Cmax) of HS-20117

    The Cmax is the maximum observed serum concentration of HS-20117

    Measured: From the date of first dose until 30 days after the final dose. A cycle is 28 days.

  12. [Phase Ib] PK parameters: Trough serum concentration (Ctrough) of HS-20117

    Ctrough is the observed serum concentration immediately prior to the next administration

    Measured: From the date of first dose until 30 days after the final dose. A cycle is 28 days.

  13. [Phase Ib] PK parameters: Area under the curve from time Zero to end of dosing interval (AUCtau) of HS-20117

    The AUCtau is defined as the area under the serum concentration-time curve during a dose interval time period(tau)

    Measured: From the date of first dose until 30 days after the final dose. A cycle is 28 days

  14. [Phase Ib] PK parameters: Time to reach maximum observed serum concentration (Tmax) of HS-20117

    The Tmax is defined as time to reach maximum observed serum concentration of HS-20117

    Measured: From the date of first dose until 30 days after the final dose. A cycle is 28 days.

  15. [Phase Ib] PK parameters: Terminal elimination half-life (t1/2) of HS-20117

    The t1/2 is defined as the time it takes for the concentration levels to fall to 50% of their value.

    Measured: From the date of first dose until 30 days after the final dose. A cycle is 28 days.

Timeline

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

  1. First posted16 May 2024
  2. Study start28 May 2024
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Jun 2030 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,080 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06417008
Sponsor's protocol ID
HS-20117-301
Status last verified
Jul 2025
First submitted
12 May 2024
Last updated
1 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing HS-20117 and Aumolertinib in people with Non-Squamous Non-Small Cell Lung Cancer, run by Hansoh BioMedical R&D Company 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 9 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 1 Aug 2025. 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 combined 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.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jialei Fu (+86 18652105685, fujl@hspharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

[Phase Ib] Objective response rate (ORR) According to response evaluation criteria in solid tumors (RECIST) v1.1 by Investigators (INVs) (time frame: From the date of first dose until the date of disease progression or withdrawal from study, up to approximately 40 months). The study lists 2 primary outcomes in all. 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 NCT06417008.

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 Aug 2025.

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