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RecruitingNCT06195527PEMBRO-KUpdated Sep 8, 2026

PEMBRO-K : Evaluation of Pembrolizumab Therapeutic Pharmacological Monitoring Benefit in NSCLC

An observational study in Non Small Cell Lung Cancer, sponsored by University Hospital, Angers. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by University Hospital, Angers · Observational

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.

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Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
75
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 873 studies in Carcinoma, Non-Small-Cell Lung with a site in France — 168 open to participants now, 327 under way, 106 of them phase 3. Carcinoma, Non-Small-Cell Lung · France.

Planned enrollment
77th of 104
75 · median 151
Started
2025
with 58 others
Observational
104 of 873
26 open now
Primary completion
2029-06
later than 257 of 326 live
Registered
728th of 873
by date

Among the 873 studies in Carcinoma, Non-Small-Cell Lung with a site in France, this one is the 77th largest by planned enrollment of the 104 observational ones that give a count, is one of 59 that started in 2025, is one of 104 observational ones, reaches primary completion later than 257 of the 326 other live ones, and was the 728th registered.

Carcinoma, Non-Small-Cell Lung

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 →

Open to participants now

168 of the 873 studies in Carcinoma, Non-Small-Cell Lung with a site in France are open now. Recruiting first, the newest first:

163 more — sign in →

All 168 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

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.

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02

Study summary

Solid cancers and their therapeutic management remain a major public health problem due to their increasing prevalence and associated mortality. Among solid cancers, lung cancer ranks 4th among incident cancers. The prognosis remains poor, 33,117 deaths were recorded in France in 2018. Two histological forms of bronchopulmonary cancer are distinguished: non-small cell lung cancers (NSCLC), which represent 85% of bronchopulmonary cancer, and small cell lung cancers. The most common forms of NSCLC are adenocarcinoma, squamous cell carcinoma and large cell carcinoma.

The emergence of new so-called targeted therapies has considerably modified the management and prognosis of oncology patients and in particular of patients with NSCLC. These new molecules were developed following the molecular characterization of tumors on the one hand and on the other hand the characterization of the role of immunity in anti-tumor defense, particularly the Programmed Death receptor pathway 1 (PD-1). Blocking this pathway restores the anti-tumor potential of these lymphocytes. Pembrolizumab is a humanized monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with the Programmed Death Ligand-1 (PDL1) and Programmed Death Ligand-2 (PDL2), expressed by tumor cells but also by cells in the microenvironment. tumor and by antigen-presenting cells. Pembrolizumab thus potentiates T cell responses, including anti-tumor responses, by blocking the binding of PD-1 with PDL1 and PDL2.

Pembrolizumab currently has marketing authorization (MA) for the treatment of NSCLC. Despite therapeutic progress due, among other things, to the emergence of anti-PD-1 antibodies including pembrolizumab, the prognosis of NSCLC remains poor and the use of pembrolizumab is sometimes limited by the occurrence of adverse effects.

The pharmacokinetics of pembrolizumab was studied pre-marketing in patients with melanoma, NSCLC or metastatic or unresectable carcinomas. However, there are no data relating to the pharmacokinetic (PK) / clinical response (pharmacodynamic / PD) relationship of pembrolizumab, in real life. No prospective pharmacological study has in fact been published to date, especially in patients treated as part of the management of NSCLC. The absence of such studies - in real life - constitutes a pitfall given the existence of a possible association between PK data and the clinical response and/or toxicity of pembrolizumab.

03

Conditions studied

  • Non Small Cell Lung Cancer
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This is a population pharmacokinetic study aimed at establishing the PK-PD relationship in patients with NSCLC treated with pembrolizumab (non-comparative descriptive study).

Taking into account the half-life (26 days) and the time necessary to obtain the equilibrium state (16 weeks), the choice was made to take residual and peak samples during administrations. This sampling strategy will allow the construction and validation of the PK model.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 years or more
  • patient with NSCLC
  • pembrolizumab treatment (monotherapy or not) with a placed line (peripheral catheter, PICC or implantable port)

Exclusion criteria

Exclusion Criteria:

  • objection to participate in the study
  • patient under judicial protection
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
75 participants (estimated)
Patient registry
No

This study also gives Pembrolizumab. No intervention listed here names it: that was found by reading the record.

06

What researchers measure

Primary outcomes

  1. Pembrolizumab efficiency Month 2

    Pembrolizumab effectiveness according to RECIST's radiological criteria

    Time frame: month 2

Secondary outcomes

  1. Pembrolizumab efficiency Month 4

    Pembrolizumab effectiveness according to RECIST's radiological criteria

    Time frame: month 4

  2. Pembrolizumab efficiency Month 12

    Pembrolizumab effectiveness according to RECIST's radiological criteria

    Time frame: month 12

  3. Pembrolizumab toxicity Month 18

    All adverse/toxic reactions collected by Regional Safety center until 18 months

    Time frame: month 18

07

Study locations

1 of 2 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2025 (actual). Primary completion is estimated for Jun 2029, 42 months after the start.

Of 356 non-industry observational studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 126. This study's planned 42 months is below that.

Counting every sponsor, half of 498 studies reached it within 55 months; a quarter within 35 and three quarters within 83.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 22, 2023
First posted
Jan 8, 2024
StartActual
Dec 17, 2025
Primary completionEst.
Jun 2029
CompletionEst.
Jun 2029
Last update
Sep 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06195527
Responsible party
Sponsor
First posted
Jan 8, 2024
Start date
Dec 17, 2025
Primary completion
Jun 2029 (estimated)
Completion
Jun 2029 (estimated)
Last update
Sep 8, 2026

Study contacts

Guillaume DREVIN, Doctor
Contact
Guillaume.Drevin@chu-angers.fr
0241354551
Chadi ABBARA, Doctor
Contact
Chadi.Abbara@chu-angers.fr
0241353644
Guillaume DREVIN, Doctor
study director · University Hospital, Angers

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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