Non-Small Cell Lung CancerNCT06756217
68Ga-grazytracer PET/CT for Early Assessment of Response to Neoadjuvant Immunotherapy in Resectable NSCLC
An observational study of Non-Small Cell Lung Cancer, run by Ruijin Hospital at 1 site in China.
Trial summary
The purpose of this study is to explore the effectiveness of 68Ga-grazytracer PET/CT in early evaluation of neoadjuvant immunotherapy response in resectable NSCLC. 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?
- 68Ga-grazytracer PET/CT
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2024to 30 Dec 2027
- Phase
- Observational
- 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
Study population: NSCLC patients requiring neoadjuvant immunotherapy
Who may be able to join
- Pre-treatment stage as clinical IB-IIIA (AJCC/UICC 8th Edition);
- Curative resectability has to be explicitly verified by the experienced surgical investigator;
- Histologically confirmed diagnosis of primary non-small lung cancer.
- Men and women aged 18 Years to 75 Years;
- Eastern Cooperative Oncology Group (ECOG) performance status: 0-1;
- expected survival ≥ 6 months;
- Sign on the informed consent form (ICF).
Who cannot join
- Histologically confirmed were NOT NSCLC;
- Lung cancer that can not be resected or has distant metastasis, or for other reasons can not tolerate surgery;
- Patients with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colorectal, endometrial, cervical, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period;
- Any active or history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications. The subjects were innate or acquired immunodeficiency (such as HIV), or active hepatitis (hepatitis B reference: HBsAg) positive; Hepatitis C reference: HCV antibody positive;
- Uncontrolled diabetes or fasting blood glucose ≥11.0 mmol/L on the day of the test;
- Women who are or may become pregnant, and lactating women are excluded;
- Having a history of severe cardiovascular disease, severe myelosuppression and severe hepatic and renal insufficiency. Having a known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
- Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information.
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
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Hecheng Li, MD, PHD, 021-64370045, lihecheng2000@hotmail.com
Hecheng Li, MD, PHD
About this study
The purpose of this study is to explore the effectiveness of 68Ga-grazytracer PET/CT in early evaluation of neoadjuvant immunotherapy response in resectable NSCLC.
Read the detailed description
It is challenging to noninvasively early evaluate the immunotherapy response of cancer. The study will evaluate the application value of 68Ga-grazytracer PET/CT in the early evaluation of neoadjuvant immunotherapy response in resectable non-small cell lung cancer (NSCLC). Potential participants will be assessed for inclusion, including the verification of clinical stage and eligibility. Eligible patients with clinically stage IB-IIIA NSCLC will be received standardized neoadjuvant immunotherapy (every 3 weeks for 3 cycles). Patients with nonsquamous NSCLC will be received pembrolizumab plus platinum-pemetrexed, and lung squamous cell carcinoma patients will be received pembrolizumab plus platinum-paclitaxel. 68Ga-grazytracer PET/CT imaging will be performed at baseline and before cycle 3. Pathological response of the primary (MPR vs. Non-MPR), imaging response (iPR vs. Non-iPR; MR vs. MD), and 68Ga-grazytracer PET/CT imaging (Positive vs. Negative) will be given special attention.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- 68Ga-grazytracer PET/CT
- 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.
68Ga-grazytracer PET/CTDiagnostic test
68Ga-grazytracer is designed to target granzyme B, and showed excellent in vivo metabolic stability and favorable targeting efficiency during immune responses. 68Ga-grazytracer PET/CT could directly display the killing effect of CD8+T cells on tumor. All enrolled patients underwent the same 68Ga-grazytracer PET/CT imaging.
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathological Response (MPR)
Defined as the incidence rate in postoperative pathology where the percentage of surviving tumor cells in the tumor bed is ≤ 10%, regardless of the presence or absence of live tumor cells in the lymph nodes.
Measured: MPR will be assessed within 3 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start30 Dec 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 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 Ruijin HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756217
- Sponsor's protocol ID
- RTS-024
- Status last verified
- Dec 2024
- First submitted
- 25 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga-grazytracer PET/CT for Early Assessment of Response to Neoadjuvant Immunotherapy in Resectable NSCLC
- ClinicalTrials.gov ID
- NCT06756217
- Acronym / sponsor ID
- RTS-024
- Conditions
- Non-Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 30 Dec 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 1 Jan 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.
The purpose of this study is to explore the effectiveness of 68Ga-grazytracer PET/CT in early evaluation of neoadjuvant immunotherapy response in resectable NSCLC.
Detailed description
It is challenging to noninvasively early evaluate the immunotherapy response of cancer. The study will evaluate the application value of 68Ga-grazytracer PET/CT in the early evaluation of neoadjuvant immunotherapy response in resectable non-small cell lung cancer (NSCLC). Potential participants will be assessed for inclusion, including the verification of clinical stage and eligibility. Eligible patients with clinically stage IB-IIIA NSCLC will be received standardized neoadjuvant immunotherapy (every 3 weeks for 3 cycles). Patients with nonsquamous NSCLC will be received pembrolizumab plus platinum-pemetrexed, and lung squamous cell carcinoma patients will be received pembrolizumab plus platinum-paclitaxel. 68Ga-grazytracer PET/CT imaging will be performed at baseline and before cycle 3. Pathological response of the primary (MPR vs. Non-MPR), imaging response (iPR vs. Non-iPR; MR vs. MD), and 68Ga-grazytracer PET/CT imaging (Positive vs. Negative) will be given special attention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NSCLC patients requiring neoadjuvant immunotherapy
Key inclusion criteria (7 listed)
- Pre-treatment stage as clinical IB-IIIA (AJCC/UICC 8th Edition);
- Curative resectability has to be explicitly verified by the experienced surgical investigator;
- Histologically confirmed diagnosis of primary non-small lung cancer.
- Men and women aged 18 Years to 75 Years;
- Eastern Cooperative Oncology Group (ECOG) performance status: 0-1;
Key exclusion criteria (8 listed)
- Histologically confirmed were NOT NSCLC;
- Lung cancer that can not be resected or has distant metastasis, or for other reasons can not tolerate surgery;
- Patients with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colorectal, endometrial, cervical, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period;
- Any active or history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications. The subjects were innate or acquired immunodeficiency (such as HIV), or active hepatitis (hepatitis B reference: HBsAg) positive; Hepatitis C reference: HCV antibody positive;
- Uncontrolled diabetes or fasting blood glucose ≥11.0 mmol/L on the day of the test;
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 |
|---|---|---|
| 68Ga-grazytracer PET/CT68Ga-grazytracer is designed to target granzyme B, and showed excellent in vivo metabolic stability and favorable targeting efficiency during immune responses. 68Ga-grazytracer PET/CT could directly display the killing effect of CD8+T cells on tumor. All enrolled patients underwent the same 68Ga-grazytracer PET/CT imaging. | Diagnostic test | – |
Primary outcome
Major Pathological Response (MPR)
Time frame: MPR will be assessed within 3 weeks after surgery
Defined as the incidence rate in postoperative pathology where the percentage of surviving tumor cells in the tumor bed is ≤ 10%, regardless of the presence or absence of live tumor cells in the lymph nodes.
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 1 Jan 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, run by Ruijin Hospital 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 7 inclusion and 8 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 1 Jan 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.
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 Hecheng Li, MD, PHD (021-74370045, lihecheng2000@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathological Response (MPR) (time frame: MPR will be assessed within 3 weeks after surgery). 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 1 Jan 2025.