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PHASE 1b STUDY OF HS-20122 COMBINED THERAPY IN NSCLC

ConditionLung Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHansoh BioMedical R&D Company

About this trial

This is a multi-center, open-label, phase I study to evaluate the safety, efficacy, pharmacokinetics (PK), and immunogenicity of HS-20122 combined therapy in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Locally advanced or metastastic NSCLC;

Received at least 1 line SoC,or treatment naïve;

With at least 1 target lesion according to RECIST 1.1.

Appropriate organ function

Disqualifiers

Insufficient wash out duration of prior systemic anticancer therapy

Local radiotherapy within 2 weeks prior to first dose of investigational drug

Pleural/abdominal effusion requires clinical intervention

Major surgery within 4 weeks prior to first dose of investigational drug

Trial design

Design model

Parallel

Treatments tested in this trial

  • HS-20122+Aumolertinib

    Drug

    EGFR mut NSCLC, receive HS-20122+Aumolertinib

  • HS-20122+Adbrelimab

    Drug

    EGFRwt NSCLC,receive HS-20122+Adbrelimab

  • HS-20122+Adbrelimab+Platinum-based Chemo

    Drug

    EGFR wt NSCLC,receive HS-20122+Adbrelimab+ Platinum-based Chemo

Treatment groups

396 Participants
are divided into 3 treatment groups
Group A: HS-20122+AumolertinibExperimental treatment 1 intervention
Group B: HS-20122+AdbrelimabExperimental treatment 1 intervention
Group C: HS-20122+Adbrelimab+Platinum-based ChemoExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

RP2D for Combination

To evaluate the potent and tolerated of combination(s) and dosage(s) of HS-20122 based therapy in subjects with locally advanced or metastatic NSCLC who have experienced disease progression on or after prior treatment, which suitable for a Phase II trial

Time frame
Through the full duration of this trial, approximately 2 years
2

ORR

Investigator evaluated overall response rate, to evaluate the efficacy of each combination;

Time frame
Through the full duration of this trial, approximately 2 years；
3

TEAE

incidence of Investigator evaluated Treatment Emerged Adverse Events, graded per CTCAE V5.0

Time frame
Through the full duration of this trial, approximately 2 years；
4

TRAE

incidence of Investigator evaluated Treatment Related Adverse Events, graded per CTCAE V5.0

Time frame
Through the full duration of this trial, approximately 2 years；

Secondary outcomes

1

Duration of Response

Investigator evaluated Duration of Response

Time frame
Through the full duration of this trial ,approximately 2 years
2

Disease Control Rate

Investigator evaluated Disease Control Rate

Time frame
Through the full duration of this trial ,approximately 2 years；
3

Progression Free Survival

Investigator evaluated duration of Progression Free Survival

Time frame
Through the full duration of this trial, approximately 2 years；
4

Overall Survival

Investigator evaluated duration of Overall Survival

Time frame
Through the full duration of this trial ,approximately 2 years；

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hansoh BioMedical R&D Company

Lead sponsor

Source ClinicalTrials.gov
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