Multiple Pulmonary NodulesPhase 2NCT04047186
Neoadjuvant Immunotherapy in Early Stage Non-small-cell Lung Cancer Presenting as Synchronous Ground-glass Nodules
A Phase 2 study testing Tislelizumab Injection in people with Multiple Pulmonary Nodules, run by XiangNing Fu at 1 site in China.
Trial summary
Neoadjuvant Immunotherapy in Early Stage Non-small-cell Lung Cancer Presenting as Synchronous Ground-glass Nodules: a pilot study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Pulmonary Nodules
- What is being tested?
- Tislelizumab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 30 May 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- not less than two GGNs on chest CT
- at least one lesion is diagnosed as NSCLC from biopsy pathology
- no contraindication for surgery
- ECOG score of 0 or 1
- no detectable evidence of distant metastasis
Who cannot join
- medical history of malignancy
- pregnant or breeding period
- severe organ failure (heart, liver, kidney, and lung)
- high risk of cerebral-cardiovascular evens
- infection out of control
- received or receiving chemo- and radiotherapy
Show all 10Show fewer
- history of severe reaction due to allergy or hypersensitivity
- severe mental disorder
- currently been enrolled in other trials
- autoimmune or chronic inflammatory disease
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital Affiliated to Huazhong Technology Hospital
Wuhan, Hubei, 430030
About this study
Official title: Neoadjuvant Anti-PD-1 Therapy in Early Stage Non-small-cell Lung Cancer Presenting as Synchronous Ground-glass Nodules: a Pilot Study
Neoadjuvant Immunotherapy in Early Stage Non-small-cell Lung Cancer Presenting as Synchronous Ground-glass Nodules: a pilot study
Read the detailed description
In many cases, non-small-cell lung cancer(NSCLC) manifested as synchronous ground-glass nodules(GGNs) and makes complete surgical resection impossible. At the same time, there is no good solution for the remaining GGNs after resection of the main lesion. Theoretically, pre-operative anti-PD-1 therapy is optimal for promoting anti-tumor immune response on the basis of maximum tumor mutational burden (TMB). In addition, neoadjuvant immunotherapy should have long-term anti-tumor effect even after surgery, because tumor recurrence may cause memory cells activation and differentiation. This is a pilot study to analysis the pathological remission rate of neoadjuvant immunotherapy and adverse events related to the treatment
- Conditions
- Multiple Pulmonary Nodules
- Being tested
- Tislelizumab Injection
- Keywords
- immunotherapy, Multiple Pulmonary Nodules, Lung Neoplasms
- Medical subject headings
- Multiple Pulmonary Nodules, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tislelizumab InjectionDrug
Patients in the experimental group receive Tislelizumab Injection
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant PD-1 group | Experimental | receiving neoadjuvant therapy of programmed death-1 (pd-1) immune checkpoint inhibitor Receives: Drug: Tislelizumab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Measured: twelve weeks
Secondary outcomes (1)
treatment-related adverse events
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start1 Jul 2019
- Primary completion31 Dec 2024
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Pulmonary NodulesStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- XiangNing Fu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, XiangNing Fu, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047186
- Sponsor's protocol ID
- 2019CR107
- Status last verified
- Sep 2025
- First submitted
- 4 Aug 2019
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: According to regulation of institution, IPD can not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Anti-PD-1 Therapy in Early Stage Non-small-cell Lung Cancer Presenting as Synchronous Ground-glass Nodules: a Pilot Study
- ClinicalTrials.gov ID
- NCT04047186
- Acronym / sponsor ID
- 2019CR107
- Conditions
- Multiple Pulmonary Nodules
- Keywords
- immunotherapy, Multiple Pulmonary Nodules, Lung Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- XiangNing FuUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 6 Aug 2019 (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.
Neoadjuvant Immunotherapy in Early Stage Non-small-cell Lung Cancer Presenting as Synchronous Ground-glass Nodules: a pilot study
Detailed description
In many cases, non-small-cell lung cancer(NSCLC) manifested as synchronous ground-glass nodules(GGNs) and makes complete surgical resection impossible. At the same time, there is no good solution for the remaining GGNs after resection of the main lesion. Theoretically, pre-operative anti-PD-1 therapy is optimal for promoting anti-tumor immune response on the basis of maximum tumor mutational burden (TMB). In addition, neoadjuvant immunotherapy should have long-term anti-tumor effect even after surgery, because tumor recurrence may cause memory cells activation and differentiation. This is a pilot study to analysis the pathological remission rate of neoadjuvant immunotherapy and adverse events related to the treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant PD-1 group | Experimental | Drug: Tislelizumab Injectionreceiving neoadjuvant therapy of programmed death-1 (pd-1) immune checkpoint inhibitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- not less than two GGNs on chest CT
- at least one lesion is diagnosed as NSCLC from biopsy pathology
- no contraindication for surgery
- ECOG score of 0 or 1
- no detectable evidence of distant metastasis
Key exclusion criteria (10 listed)
- medical history of malignancy
- pregnant or breeding period
- severe organ failure (heart, liver, kidney, and lung)
- high risk of cerebral-cardiovascular evens
- infection out of control
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 |
|---|---|---|
| Tislelizumab InjectionPatients in the experimental group receive Tislelizumab Injection | Drug | neoadjuvant PD-1 group |
Primary outcome
Objective Response Rate
Time frame: twelve weeks
1 secondary outcome
treatment-related adverse events
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No. According to regulation of institution, IPD can not be shared.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab Injection in people with Multiple Pulmonary Nodules, run by XiangNing Fu 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 23 Sep 2025. 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: twelve weeks). 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 23 Sep 2025.