NCT06417008 A Study of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer
| NCT ID | NCT06417008 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Hansoh BioMedical R&D Company |
| Condition | Non-Squamous Non-Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,080 participants |
| Start Date | 2024-05-28 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 1,080 participants in total. It began in 2024-05-28 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 \[Exon 19del\] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).
Eligibility Criteria
Inclusion 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 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. * 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. Exclusion Criteria: * Received or are receiving the following treatments: 1. Previous or current treatment with MET targeted therapy or EGFR targeted antibodies or antibody-drug conjugates (ADC). 2. Traditional Chinese medicine indicated for tumors, major surgery or other local therapy within washout period to the first dose of study drug. 3. Presence of pleural effusion/ascites requiring clinical intervention; presence of pericardial effusion. 4. 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 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.
Contact & Investigator
Dingzhi Huang, M.D.
PRINCIPAL INVESTIGATOR
Tianjin Medical University Cancer Institute and Hospital
Frequently Asked Questions
Who can join the NCT06417008 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Non-Squamous Non-Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06417008 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06417008 currently recruiting?
Yes, NCT06417008 is actively recruiting participants. Contact the research team at fujl@hspharm.com for enrollment information.
Where is the NCT06417008 trial being conducted?
This trial is being conducted at Tianjin, China, Hangzhou, China.
Who is sponsoring the NCT06417008 clinical trial?
NCT06417008 is sponsored by Hansoh BioMedical R&D Company. The principal investigator is Dingzhi Huang, M.D. at Tianjin Medical University Cancer Institute and Hospital. The trial plans to enroll 1,080 participants.
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