T-Cell PET Imaging With [18F]F-AraG in Lung Cancer

NCT03311672 | Withdrawn Phase 2 FDA Drug

• 2 other identifiers: 176513NCI-2018-02158
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline (after two cycles of pembrolizumab)

Secondary Outcomes (1)

• The detection of out-of-target radiation-mediated immune modulation in lymph nodes using [18F]F-AraG PET

  Baseline (after two cycles of pembrolizumab)

Study Arms (2)

Cohort 1 - Immunotherapy Alone

EXPERIMENTAL

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

Cohort 2 - Immunotherapy with Stereotactic Radiation

EXPERIMENTAL

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

Interventions

[18F]F-Ara-G DRUG

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

Cohort 1 - Immunotherapy Alone; Cohort 2 - Immunotherapy with Stereotactic Radiation

Pembrolizumab DRUG

All study participants will receive pembrolizumab every 3 weeks, for 2 cycles.

Also known as: Keytruda

Cohort 1 - Immunotherapy Alone; Cohort 2 - Immunotherapy with Stereotactic Radiation

PET/CT scan RADIATION

Scan will be done after two cycles of immunotherapy +/- stereotactic radiation therapy.

Cohort 1 - Immunotherapy Alone; Cohort 2 - Immunotherapy with Stereotactic Radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 18 years
• Histologically or cytologically documented stage I-IIIA non-small cell lung cancer (NSCLC)
• Eligible for with plan to undergo immunotherapy alone or both immunotherapy and stereotactic radiation therapy as part of NCT03217071
• In female patients, negative pregnancy test with no plans to become pregnant during the duration of the study
• Able to provide informed consent and follow the study guidelines

You may not qualify if:

• \. Female patients who are pregnant or breastfeeding

Sponsors & Collaborators

• University of California, San Francisco: lead
• CellSight Technologies, Inc.: collaborator

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sue Yom, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: October 17, 2017
• Study Start: November 26, 2017
• Primary Completion: October 15, 2019
• Study Completion: October 15, 2019
• Last Updated: October 21, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share