ZG005 plus gecacitinib for advanced non-small cell lung cancer
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
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 |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd Industry-sponsored |
| Drugs / interventions | Gecacitinib |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06903377 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality
- Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Cong Zhang
- Email: zhangc@zelgen.com
- Phone: 17602176888
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.