Clinical trial Recruiting at 1 site Phase1; Phase2 Interventional Ages 18 to 75

ZG005 plus gecacitinib for advanced non-small cell lung cancer

Official title: A Multicenter, Open-label, Dose-Escalation and Dose-Expansion Phase I/II Study of ZG005 Combined With Gecacitinib in Patients With Advanced Non-Small Cell Lung Cancer

Run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd · NCT06903377 · Data updated 2026-11-12

This trial tests whether giving ZG005 by injection together with oral gecacitinib is safe and may help adults 18–75 with advanced non-small cell lung cancer that progressed after PD‑1/PD‑L1 therapy.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment50 (estimated)
SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd
Industry-sponsored
Drugs / interventionsGecacitinib
Locations1 site (Shanghai, Shanghai Municipality)
StatusRecruiting
StartedMay 23, 2025
Main results expectedApril 2027
Study endsMay 2027
Registry record updatedJanuary 5, 2026
Trial IDNCT06903377 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–75 with locally advanced or metastatic squamous or non-squamous NSCLC who progressed on PD‑1/PD‑L1 therapy and do not have CNS metastases or recent other cancers are ideal candidates.

Probably not a fit

Patients with brain metastases, another malignancy within the past five years, or those judged unsuitable by the investigator are unlikely to benefit or be eligible for this trial.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter Phase 1/2 trial of ZG005 combined with gecacitinib in adults with locally advanced, recurrent, or metastatic non-small cell lung cancer who have failed prior PD‑1/PD‑L1 therapy. The Phase 1 portion focuses on defining safety, tolerability, and an appropriate dose or regimen of the combination, while the Phase 2 portion examines preliminary anti-tumor activity. Key eligibility includes histologically confirmed squamous or non-squamous NSCLC, age 18–75, and unsuitability for curative therapy; patients with central nervous system metastases or other malignancies within 5 years are excluded. Participants will receive ZG005 injections and oral gecacitinib with clinical and radiologic follow-up to monitor adverse events and tumor response.

Why it matters

Potential benefit: If successful, the combination could offer a new treatment option for patients whose NSCLC has progressed after PD‑1/PD‑L1 therapy.

How similar studies have gone: Combining antibody therapies with JAK-pathway inhibitors is an emerging approach with limited early-phase data and some preliminary signals but has not yet been proven in larger trials.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

  • Shanghai Chest Hospital
    Shanghai, Shanghai Municipality, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.