Non-small Cell Lung CancerPhase 1/2NCT06903377
Study of ZG005 Combined With Gecacitinib in Patients With Advanced Non-Small Cell Lung Cancer
A Phase 1/2 study testing ZG005 for Injection and Gecacitinib Hydrochloride Tablets in people with Non-small Cell Lung Cancer, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- ZG005 for Injection and Gecacitinib Hydrochloride Tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 23 May 2025to May 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality
Xinghao Ai
About this study
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
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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- ZG005 for Injection, Gecacitinib Hydrochloride Tablets
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZG005 for InjectionBiological
Also called ZG005
intravenous infusion
Gecacitinib Hydrochloride TabletsDrug
Also called Gecacitinib
Oral
| Study group | Role | What they receive |
|---|---|---|
| Part1-Group A | Experimental | ZG005 20mg/kg IV Q3W+Gecacitinib 50mg po Bid Receives: Biological: ZG005 for Injection; Drug: Gecacitinib Hydrochloride Tablets |
| Part1-Group B | Experimental | ZG005 20mg/kg Q3W+Gecacitinib 100mg po Bid Receives: Biological: ZG005 for Injection; Drug: Gecacitinib Hydrochloride Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event (AE)
Measured: Up to 2 years
Secondary outcomes (1)
Objective response rate (ORR)
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start23 May 2025
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Suzhou Zelgen Biopharmaceuticals Co.,LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Wu, Study chair, Suzhou Zelgen Biopharmaceuticals Co.,Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903377
- Sponsor's protocol ID
- ZG005-JAK-001
- Status last verified
- Dec 2025
- First submitted
- 24 Mar 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06903377
- Acronym / sponsor ID
- ZG005-JAK-001
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 23 May 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part1-Group A | Experimental | Biological: ZG005 for Injection, Drug: Gecacitinib Hydrochloride TabletsZG005 20mg/kg IV Q3W+Gecacitinib 50mg po Bid |
| Part1-Group B | Experimental | Biological: ZG005 for Injection, Drug: Gecacitinib Hydrochloride TabletsZG005 20mg/kg Q3W+Gecacitinib 100mg po Bid |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZG005 for InjectionAlso: ZG005intravenous infusion | Biological | Part1-Group A, Part1-Group B |
| Gecacitinib Hydrochloride TabletsAlso: GecacitinibOral | Drug | Part1-Group A, Part1-Group B |
Primary outcome
Adverse Event (AE)
Time frame: Up to 2 years
1 secondary outcome
Objective response rate (ORR)
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason Wu study chair
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ZG005 for Injection and Gecacitinib Hydrochloride Tablets in people with Non-small Cell Lung Cancer, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cong Zhang (17602176888, zhangc@zelgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event (AE) (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.