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New treatment option for Non-Squamous Non-Small Cell Lung Cancer
Official title A Study of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT06417008
What this study is testing
What is HS-20117?
HS-20117 is an investigational medicine, being studied as a potential treatment for non-squamous non-small cell lung cancer.
Also referred to as PM1080.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Agree to provide fresh or archival tumor tissue.
- At least one target lesion per the RECIST v1.1.
- ECOG performance status of 0-1.
You likely can't join if
- 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...
- Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.
See the full eligibility criteria
- 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...
- 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.
- 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.
- 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.
- 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 people 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.
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China; Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.