HS-20117 combined with aumolertinib for advanced EGFR‑mutant non-squamous lung cancer

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

This tests whether adding the bispecific antibody HS-20117 to aumolertinib helps people with advanced, treatment‑naive, EGFR‑mutant non‑squamous non‑small cell lung cancer live longer or have better tumor control.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 1080 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Hansoh BioMedical R&D Company (Industry-sponsored)
• Drugs / interventions: Aumolertinib
• Locations: 2 sites (Tianjin, Tianjin Municipality and 1 other locations)
• Trial ID: NCT06417008 on ClinicalTrials.gov

What this trial studies

This is a multicenter Phase Ib/III study of HS-20117, a fully human EGFR‑MET IgG1‑like bispecific antibody, given with the EGFR tyrosine kinase inhibitor aumolertinib in patients with locally advanced or metastatic non‑squamous NSCLC harboring EGFR sensitizing mutations (Exon 19 deletions or Exon 21 L858R). Phase Ib uses a dose‑expansion design to characterize safety, tolerability, pharmacokinetics, immunogenicity, and to determine the recommended Phase III dose. After dose confirmation, a randomized, open‑label Phase III portion will compare HS-20117 plus aumolertinib versus aumolertinib alone to measure efficacy and safety outcomes. The study enrolls adults with measurable disease and ECOG 0–1 at participating cancer centers in China.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–75 with newly diagnosed, treatment‑naive, locally advanced or metastatic non‑squamous NSCLC that is EGFR sensitizing mutation positive (Exon 19del or Exon 21 L858R), have at least one measurable lesion and ECOG performance status 0–1.

Not a fit: Patients with non‑sensitizing EGFR mutations, EGFR wild‑type tumors, prior MET targeted therapy or prior EGFR targeted antibodies/ADCs, squamous histology, or poor performance status are unlikely to benefit from this combination.

Why it matters

Potential benefit: If successful, the combination could improve tumor control and extend progression‑free survival compared with aumolertinib alone for EGFR‑mutant non‑squamous NSCLC patients.

How similar studies have performed: Bispecific EGFR‑MET antibodies and combinations targeting MET alongside EGFR TKIs are an emerging approach with some early promising signals but limited confirmatory phase III data to date.

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.

Where this trial is running

Tianjin, Tianjin Municipality and 1 other locations

• Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Dingzhi Huang, M.D. — Tianjin Medical University Cancer Institute and Hospital
• Study coordinator: Jialei Fu

Conditions Non-Squamous Non-Small Cell Lung Cancer; Non-Small Cell Lung Cancer; HS-20117; Epidermal Growth Factor Receptor; c-Mesenchymal-Epithelial Transition; Bispecific Antibody