Clinical trial · Observational
68Ga-grazytracer PET/CT for Early Assessment of Response to Neoadjuvant Immunotherapy in Resectable NSCLC
NCT06756217CI-TRIAL-00084286recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-grazytracer PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Major Pathological Response (MPR)
- timeFrame
- MPR will be assessed within 3 weeks after surgery
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pre-treatment stage as clinical IB-IIIA (AJCC/UICC 8th Edition); 2. Curative resectability has to be explicitly verified by the experienced surgical investigator; 3. Histologically confirmed diagnosis of primary non-small lung cancer. 4. Men and women aged 18 Years to 75 Years; 5. Eastern Cooperative Oncology Group (ECOG) performance status: 0-1; 6. expected survival ≥ 6 months; 7. Sign on the informed consent form (ICF). Exclusion Criteria: 1. Histologically confirmed were NOT NSCLC; 2. Lung cancer that can not be resected or has distant metastasis, or for other reasons can not tolerate surgery; 3. 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; 4. 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; 5. Uncontrolled diabetes or fasting blood glucose ≥11.0 mmol/L on the day of the test; 6. Women who are or may become pregnant, and lactating women are excluded; 7. 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; 8. 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.
References
Publications (0)
Data not yet available
No reference posted for this study.