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
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd Industry-sponsored |
| Drugs / interventions | Gecacitinib |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | May 23, 2025 |
| Main results expected | April 2027 |
| Study ends | May 2027 |
| Registry record updated | January 5, 2026 |
| Trial ID | NCT06903377 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
- Study coordinator: Cong Zhang
- Email: zhangc@zelgen.com
- Phone: 17602176888
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.