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Non Small Cell Lung CancerPhase 1PINNACLENCT03514719

PD-L1 Imaging in Non Small Cell Lung Cancer' (PINNACLE)

A Phase 1 study testing 89Zr-avelumab PET and Avelumab in people with Non Small Cell Lung Cancer, run by Radboud University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this feasibility study, a zirconium-89 (89Zr)-avelumab positron emission tomography (PET) scan will be performed in 37 patients prior to treatment with avelumab to: 1. assess the tumor and systemic tissue uptake 89Zr-avelumab 2. assess the potential to predict avelumab treatment response Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
89Zr-avelumab PET and Avelumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteNetherlands
Study dates
1 Oct 2018to 2 Dec 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subjects aged ≥ 18 years, and >50 years in patients with resectable stage Ia (≥T1b tumor) - IIIa NSCLC)
  • Histological or cytologic proven stage IIIb/IV NSCLC or resectable stage Ia (≥T1b tumor) - IIIa NSCLC, where no pathological evaluation of mediastinal lymph nodes by mediastinoscopy is indicated according to the multidisciplinary tumor board
  • ECOG performance score (0-1)
  • At least one lesion with a tumour size ≥ 1 cm
  • Haematologic function: absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, and haemoglobin ≥ 9 g/dL (may have been transfused)
  • Hepatic function: total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range and AST and ALT levels ≤ 2.5 × ULN for all subjects or AST and ALT levels ≤ 5 x ULN (for subjects with documented metastatic disease to the liver).
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  • Estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method)
  • Highly effective contraception for both male and female subjects throughout the study and for at least after avelumab treatment administration intrinsic factor the risk of conception exists
  • Fit for surgery (for patients with resectable stage Ia-IIIa disease), as assessed by treating thoracic surgeon / anesthesiologists based on sufficient cardiopulmonary status and absence of major contra-indications for surgery according to local guidelines

Who cannot join

  • Immunosuppressants: "Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (eg, intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)."
  • Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent: Subjects with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible
  • Prior organ transplantation, including allogeneic stem cell transplantation
  • Infections: active infection requiring systemic therapy
  • HIV/AIDS: known history for testing positive to an HIV test or known acquired immunodeficiency syndrome (AIDS)
  • Hepatitis: hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or confirmatory HCV RNA if anti-HCV antibody screening test positive)
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  • Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines
  • Hypersensitivity to study drug: "Known prior severe hypersensitivity reactions to investigational product or any component in its formulations, including known severe hypersensitivity reactions to antibodies (Grade ≥ 3 NCI CTCAE v 4.03)
  • Cardiovascular disease: "Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication."8. Persisting toxicity related to prior therapy of Grade >1 NCI-CTCAE v 4.03; however, alopecia and sensory neuropathy Grade ≤ 2 is acceptable
  • Other persisting toxicities: Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 > 1); however, alopecia, sensory neuropathy Grade
  • ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable.
  • Other severe acute or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Radboud University

    Nijmegen

Other trials in Netherlands

About this study

In this feasibility study, a zirconium-89 (89Zr)-avelumab positron emission tomography (PET) scan will be performed in 37 patients prior to treatment with avelumab to:

  1. assess the tumor and systemic tissue uptake 89Zr-avelumab
  2. assess the potential to predict avelumab treatment response
Read the detailed description

The programmed death 1 (PD1)/ programmed death ligand 1 (PD-L1) pathway plays an important role in regulating the T-cell anti tumor response. Blocking this interaction with the anti PD-L1 monoclonal antibody avelumab is effective in patients with non-small cell lung cancer (NSCLC) resulting in durable disease control rates. Currently, PD-L1 expression as determined by immune histochemistry (IHC) is the best available biomarker for treatment response, but standardized scoring criteria are lacking and the risk for sampling errors exists. Molecular imaging using 89Zr-labeled antibodies may overcome these limitations, enabling the visualization of PD-L1 expression in primary and metastatic tumor lesions and providing information on the in vivo accessibility of the PD-L1 target following intravenous administration.

This study enables PD-L1 PET-imaging with 89Zr-avelumab in patients with:

  • early stage NSCLC (stage Ia (≥T1b) -IIIa) followed by 2 cycles of neo-adjuvant avelumab treatment and surgical resection of the tumor.
  • advanced stage NSCLC (Stage IIIb-IV) followed by avelumab treatment until disease progression or intolerable toxicity.
Being tested
89Zr-avelumab PET, Avelumab
Keywords
89Zr-avelumab PET, avelumab
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 89Zr-avelumab PETDiagnostic test

    Also called ImmunoPET

    89Zr-avelumab injection followed by 89Zr-Avelumab PET scan

  • AvelumabDrug

    Early stage disease (stage Ia (≥T1b tumor)-IIIa: neo-adjuvant avelumab treatment (10mg/kg iv q2w) for a maximum duration of 2 cycles after PET-imaging, followed by surgical resection of the tumor with curative intent

    Stage IIIb-IV disease: systemic treatment with avelumab 10mg/kg iv q2w after PET-imaging

Study groups in NCT03514719
Study groupRoleWhat they receive
89Zr-avelumab PETExperimental89Zr-avelumab injection followed by 89Zr-avelumab PET
Receives: Diagnostic Test: 89Zr-avelumab PET; Drug: Avelumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tumor uptake of 89Zr-Avelumab

    Standardized uptake values (SUV) of 89Zr-Avelumab uptake in tumor lesions will be measured

    Measured: 1 year

Secondary outcomes (4)

  1. Correlation 89Zr-Avelumab uptake in tumor lesions and PD-L1 expression as determined by immunohistochemistry

    Measured: 1-2 year

  2. Correlation between 89Zr-Avelumab uptake in tumor lesions and response to (neo)-adjuvant avelumab treatment

    To assess the potential of PD-L1 PET/CT to image PD-L1 expression in tumor lesions, and predict response to (neo)-adjuvant avelumab treatment in patients with NSCLC

    Measured: 1-2 years

  3. The number of treatment delays in surgical resections

    In resectable early stage disease (stage Ia (≥T1b) - IIIa)

    Measured: 1-2 years

  4. Asses post-operative complications

    In resectable early stage disease (stage Ia (≥T1b) - IIIa)

    Measured: 1-2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2018
  2. Study start1 Oct 2018
  3. Primary completion15 Sep 2021
  4. Study completion2 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
Patients with early stage disease (stage Ia(≥T1b)-IIIa) undergo pre-treatment PET-imaging and 2 cycles of neo-adjuvant avelumab treatment. Followed by surgical resection of the tumor. Patients with stage IIIb-IV NSCLC will undergo pre-treatment PET-imaging in only part 1 of the study, and receive avelumab treatment 10mg/kg q2w until disease progression or treatment toxicity
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03514719
Sponsor's protocol ID
MS100070_0167
Acronym
PINNACLE
Status last verified
Jan 2022
First submitted
20 Apr 2018
Last updated
10 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 89Zr-avelumab PET and Avelumab in people with Non Small Cell Lung Cancer, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor uptake of 89Zr-Avelumab (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03514719.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2022.

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