Trials Sponsors Conditions Drugs Pricing

Conditions

Advanced Stage Non-small Cell Lung Cancer

Keywords

Positron Emission Tomography[18F]F-AraGT-LymphocytesLongitudinal Imaging

Outcome Measures

Primary Outcomes (3)

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
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
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 Outcomes (1)

To assess the relationship between baseline tumor uptake of [18F]F-AraG, T cell infiltration and activation state at baseline
twelve weeks

Other Outcomes (2)

To assess the relationship between change of tumor uptake of [18F]F-AraG and changes in PBMC subsets
six weeks
To visually correlate the [18F]F-AraG autoradiogram with immuno-histochemistry (IHC) read outs for tumor cells and T-cells
twelve weeks

Study Arms (1)

[18F]F-AraG PET procedures

EXPERIMENTAL

All patients will undergo a total of 3 \[18F\]F-AraG PET scanning procedures at T=0, T=2 weeks and T=6 weeks.

Diagnostic Test: [18F]F-AraG PET scan

Interventions

[18F]F-AraG PET scanDiagnostic test

\[18F\]F-AraG PET scans are performed to assess the accumulation of activated T-cells in the tumour and healthy tissue.

[18F]F-AraG PET procedures

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Amsterdam UMC, location VUmc
Otherlead
Boehringer Ingelheim
Industrycollaborator

Study Sites (1)

Amsterdam UMC, location VU University Medical Center

Amsterdam, 1081 HV, Netherlands

RECRUITING

Idris Bahce, MD, PhDCONTACT+31204444782 i.bahce@amsterdamumc.nl

Study Officials

Idris Bahce, MD, PhD
Amsterdam UMC, location VUmc
PRINCIPAL INVESTIGATOR

Central Study Contacts

Idris Bahce, MD, PhD

CONTACT

+31204444782 i.bahce@amsterdamumc.nl

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: DIAGNOSTIC
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Idris Bahce, MD, PhD, Principal Investigator

Study Record Dates

First Submitted

December 21, 2022

First Posted

January 27, 2023

Study Start

November 3, 2022

Actual (reported)

Primary Completion

January 2027

Estimated

A Clinical Imaging Study of the Changes in [18F]F-AraG Uptake Following Anti-PD-1 Therapy in Non-small Cell Lung Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (1)

Other Outcomes (2)

Study Arms (1)

[18F]F-AraG PET procedures

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (1)

Other Outcomes (2)

Study Arms (1)

[18F]F-AraG PET procedures

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations