Health TrialsbyHealthPanel

Study of ZG005 Combined With Gecacitinib in Patients With Advanced Non-Small Cell Lung Cancer

ConditionNon-small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd

About this trial

This is a multicenter Phase I/II study for patients with advanced non-small cell lung cancer who have failed PD-1/L1 therapy, aiming to evaluate the safety of ZG005 in combination with Gecacitinib in this population, as well as the preliminary efficacy of this combination regimen.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Fully understand this study and voluntarily sign the ICF.

Age 18-75 years, no gender restriction.

Patients with locally advanced or recurrent/metastatic squamous and/or non-squamous non-small cell lung cancer confirmed by histology/cytology, unsuitable for radical therapy.

Disqualifiers

Medical history, CT scan, or MRI indicates the presence of CNS metastases.

Other malignancies within 5 years.

Any other reason deeming the participant unsuitable for the study, as judged by the investigator.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ZG005 for Injection

    Biological/Vaccine

    intravenous infusion

  • Gecacitinib Hydrochloride Tablets

    Drug

    Oral

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Part1-Group AExperimental treatment 2 interventions
Group B: Part1-Group BExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Adverse Event (AE)

Time frame
Up to 2 years

Secondary outcomes

1

Objective response rate (ORR)

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

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

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Lead sponsor

Source ClinicalTrials.gov
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