A Phase 2 interventional study of [18F]F-Ara-G and Pembrolizumab in Non-small Cell Lung Cancer, sponsored by University of California, San Francisco. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-21.
Sponsored by University of California, San Francisco · Phase 2, Interventional, and Diagnostic
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Among 13 studies in Carcinoma, Non-Small-Cell Lung by University of California, San Francisco — 1 open to participants now, 2 under way, none of them phase 3. Carcinoma, Non-Small-Cell Lung · University of California, San Francisco.
Among the 13 studies in Carcinoma, Non-Small-Cell Lung by University of California, San Francisco, this one is the 9th largest by enrollment of the 12 interventional ones that give a count, is one of 3 that started in 2017, is one of 6 in phase 2, and was the 8th registered.
7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →1 of the 13 studies in Carcinoma, Non-Small-Cell Lung by University of California, San Francisco is open now, in 1 country. Recruiting first, the newest first:
University of California, San Francisco · Sites in United States
Ages 40+
By country, each count listing its studies:
Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
Median enrollment 2 across the 12 interventional studies, 1,440 across the 1 observational. Of the 7 that completed or were terminated, 2 (29%) have results posted.
This tab as a report to print or save as PDF → With an account.
University of California, San Francisco is the lead sponsor of 2,171 studies on the registry; 370 are open to participants now.
Of its 268 completed or terminated interventional studies of FDA-regulated products, 203 (76%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 13 studies in Carcinoma, Non-Small-Cell Lung by University of California, San Francisco, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This is a single-center cross-sectional imaging study in patients with localized lung cancer undergoing immunotherapy with or without stereotactic radiation therapy as part of the companion clinical trial (NCT03217071; Pembrolizumab With and Without Radiotherapy for Non-Small Cell Lung Cancer). Each patient will undergo a single [18F]F-AraG PET exam as part of this study. [18F]F-AraG will be administered at a single time point intravenously prior to PET imaging. Whole-body PET will be acquired along with a whole body low dose CT (PET/CT) used for attenuation correction and anatomic localization of [18F]F-AraG uptake, SUV calculation, and volumetric selection for radiomic analyses.
This is a single-center cross-sectional imaging study in patients with localized lung cancer undergoing immunotherapy with or without stereotactic radiation therapy as part of the companion clinical trial (NCT03217071; Pembrolizumab With and Without Radiotherapy for Non-Small Cell Lung Cancer). Each patient will undergo a single [18F]F-AraG PET exam as part of this study. [18F]F-AraG will be administered at a single time point intravenously prior to PET imaging. Whole-body PET will be acquired along with a whole body low dose CT (PET/CT) used for attenuation correction and anatomic localization of [18F]F-AraG uptake, SUV calculation, and volumetric selection for radiomic analyses.
A total of 20 patients will be enrolled over an accrual period of approximately 12 months. Approximately 10 patients will be enrolled in the immunotherapy alone cohort and approximately 10 patients will be enrolled in the immunotherapy and stereotactic radiation therapy cohort.
Patients will be evaluated one day and one week via telephone after each radiopharmaceutical injection for safety follow-up. All adverse events will be recorded. Due to the noninvasive and non-therapeutic nature of the study, potential risks of the study are anticipated to be low.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Approximately 10 patients will be enrolled in the immunotherapy alone cohort under a larger two-year industry-funded, investigator-initiated single-institution, phase II, open-label clinical trial (NCT03217071; Pembrolizumab With and Without Radiotherapy for Non-Small Cell Lung Cancer) in which patients with stage I-IIIA non-small cell lung cancer (NSCLC) are randomized to receive two cycles of systemic immunotherapy (pembrolizumab, a PD-1 inhibitor) with or without immune-priming stereotactic radiation therapy (SRT, 12 Gy) to the lateral half of the primary lung tumor prior to resection.
Drug: [18F]F-Ara-G · Drug: Pembrolizumab · Radiation: PET/CT scan
Approximately 10 patients will be enrolled in the immunotherapy with stereotactic radiation therapy cohort under a larger two-year industry-funded, investigator-initiated single-institution, phase II, open-label clinical trial (NCT03217071; Pembrolizumab With and Without Radiotherapy for Non-Small Cell Lung Cancer) in which patients with stage I-IIIA non-small cell lung cancer (NSCLC) are randomized to receive two cycles of systemic immunotherapy (pembrolizumab, a PD-1 inhibitor) with or without immune-priming stereotactic radiation therapy (SRT, 12 Gy) to the lateral half of the primary lung tumor prior to resection.
Drug: [18F]F-Ara-G · Drug: Pembrolizumab · Radiation: PET/CT scan
Administered after two cycles of immunotherapy +/- stereotactic radiation therapy as part of the PET/CT scan.
Also known as: 2'-deoxy-2'-[18F]fluoro-9-β-Darabinofuranosylguanine
All study participants will receive pembrolizumab every 3 weeks, for 2 cycles.
Also known as: Keytruda
Scan will be done after two cycles of immunotherapy +/- stereotactic radiation therapy.
The correlation between number of infiltrating CD3+ T cells/μm2 in the non-small cell lunger cancer thoracotomy specimen as quantified by immunohistochemistry and the activated T-cell concentration as determined by [18F]F-AraG PET (SUVmax)
The correlation between number of infiltrating CD3+ T cells/μm2 in the non-small cell lunger cancer thoracotomy specimen as quantified by immunohistochemistry and the activated T-cell concentration as determined by \[18F\]F-AraG PET (SUVmax)
Time frame: Baseline (after two cycles of pembrolizumab)
The detection of out-of-target radiation-mediated immune modulation in lymph nodes using [18F]F-AraG PET
The detection of out-of-target radiation-mediated immune modulation in lymph nodes using \[18F\]F-AraG PET
Time frame: Baseline (after two cycles of pembrolizumab)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2017 to primary completion in Oct 2019, 22 months.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: F-arag f-18
Carcinoma, Non-Small-Cell Lung →
University of California, San Francisco →