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).
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.
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.
Parallel
HS-20117
DrugParticipants 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)
Aumolertinib
Drug110 mg orally once daily.
[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
[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
[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.
[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.
[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.
[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
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