Advanced Stage Non-small Cell Lung Cancer Clinical Trial
— SHARPOfficial title:
A Clinical Imaging Study of the Changes in [18F]F-AraG Uptake Following Anti-PD-1 Therapy in Non-small Cell Lung Cancer
[18F]F-AraG is a promising tracer to image activated T-cells with positron emission tomography (PET). The aim of the SHARP trial is to investigate changes in [18F]F-AraG uptake following Anti-PD-1 therapy in patients with non-small cell lung cancer (NSCLC).
Status | Recruiting |
Enrollment | 15 |
Est. completion date | January 2026 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Histologically confirmed NSCLC, a histological biopsy is mandatory, negative for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) mutations - Be willing to provide either archival biopsy or fresh biopsy at screening. - Stage IIIB-IV patients that are planned to be treated with anti-PD-1 monotherapy - High PD-L-1 expression (=50% TPS) - No prior systemic therapy for the treatment of cancer - Be willing and able to provide written informed consent for the trial. - Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale - Be above 18 years of age on day of signing informed consent. Exclusion Criteria: - Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of day 0. Inhaled or topical steroids, and adrenal replacement steroid >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. - Untreated or symptomatic brain metastases - Additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. - Evidence of interstitial lung disease or active, non-infectious pneumonitis. - Active infection requiring systemic therapy. - A history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). - Active Hepatitis B or C. - Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. - Patient is pregnant or breastfeeding or expecting to conceive within the projected duration of the trial, starting with the screening visit through 12 weeks after the last administration of [18F]F-AraG. |
Country | Name | City | State |
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Netherlands | Amsterdam UMC, location VU University Medical Center | Amsterdam |
Lead Sponsor | Collaborator |
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Amsterdam UMC, location VUmc | Boehringer Ingelheim |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | To assess the relationship between change of tumor uptake of [18F]F-AraG and changes in PBMC subsets | To correlate changes in tumor [18F]F-AraG uptake as measured between baseline and 2 weeks and 6 weeks on-treatment, with changes in the immune profile of peripheral blood mononuclear cells (PBMC) as measured between baseline and 2 weeks and 6 weeks on-treatment. | six weeks | |
Other | To visually correlate the [18F]F-AraG autoradiogram with immuno-histochemistry (IHC) read outs for tumor cells and T-cells | twelve weeks | ||
Primary | To assess the relative change in uptake of [18F]F-AraG in tumor lesions and lymphoid organs on anti-PD-1 treatment | To assess the changes in tracer uptake in all tumor lesions and lymphoid organs (lymph nodes, spleen) between baseline and after 2 and 6 weeks on-treatment per [18F]F-AraG PET scan. | six weeks | |
Primary | To correlate baseline [18F]F-AraG uptake and tumor response to anti-PD-1 therapy | To correlate baseline tumor [18F]F-AraG uptake and objective response rate (ORR, defined as complete response (CR) and partial response (PR)) at 6 and 12 weeks. | twelve weeks | |
Primary | To correlate the change in [18F]F-AraG uptake between baseline and on-treatment and tumor response to anti-PD-1 therapy | To correlate change in tumor [18F]F-AraG uptake as measured between baseline and 2 weeks and 6 weeks on-treatment, respectively, and objective response rate (ORR, defined as complete response (CR) and partial response (PR)) at 6 and 12 weeks. | twelve weeks | |
Secondary | To assess the relationship between baseline tumor uptake of [18F]F-AraG, T cell infiltration and activation state at baseline | To correlate tumor [18F]F-AraG uptake at baseline with viable tumor cells and T-cell infiltration in tumor and stroma using multiplex IHC (VECTRA) analysis panels for T-cell subsets, for monocytes and metabolic milieu, and panels directed at resistance as well as RNA sequencing to assess tumor microenvironment. | twelve weeks |
Status | Clinical Trial | Phase | |
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Completed |
NCT02350764 -
Evaluate the Mediators of Sensitivity and Resistance to Nivolumab Plus Ipilimumab in Patients With Advanced NSCLCs
|
Phase 2 |