Drug Concentration Monitoring of Pembrolizumab in Non-Sma... | NCT04557007

Studies
Drug Concentration Monitoring of Pembrolizumab in Non-Small Cell Lung Cancer Patients

NCT04557007

Sponsor

Oslo University Hospital

Status

Terminated

Last Update Posted

Jan 29, 2026Actual

Enrollment

80Actual

Phase

Not provided

Conditions

NSCLC

Interventions

Pembrolizumab

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulty recruiting

Expanded Access Info

Start Date

Sep 1, 2020Actual

Primary Completion Date

Oct 1, 2022Actual

Completion Date

Oct 1, 2022Actual

First Submitted Date

Sep 2, 2020

First Submission Date that Met QC Criteria

Sep 15, 2020

First Posted Date

Sep 21, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2026

Last Update Posted Date

Jan 29, 2026Actual

Name	Class
St. Olavs Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This observational study explores associations between drug trough-levels and clinical outcomes in Non Small Cell Lung Cancer (NSCLC) patients treated with immunotherapy (pembrolizumab) either alone or combined with chemotherapy. Through-levels of pembrolizumab will be examined in blood samples collected during the first-line treatment period. In addition T-cell responses in peripheral blood and anti-drug antibodies will be monitored. Results of drug trough-levels and T-cell responses will be linked to clinical outcome. 250 patients with NSCLC will be enrolled in this trial.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment-naive NSCLC patients		Treatment-naive NSCLC patients receiving immunotherapy (pembrolizumab) alone or in combination With chemotherapy divided in groups based on treatment administered. Clinical information will be gathered at start of treatment and at evaluations every 3rd month.	Drug: Pembrolizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pembrolizumab	Drug	Drug trough-level will be measured in patients on Pembrolizumab with or without additional chemotherapy in routine care.	Treatment-naive NSCLC patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective response	Radiological response (Partial response/stable disease/Complete response)	3 months

Secondary Outcomes

Measure	Description	Time Frame
Adverse events	Adverse events >= 3	2 years
PD-1 Expression on CD-8 T-cells	Proliferation of PD-1 Expression CD-8 T-cells	First 3 months

Other Outcomes

Measure	Description	Time Frame
Pembrolizumab clearance	mg/L	3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects must be > 18 years and must voluntary sign an informed consent
Treatment-naïve patients with advanced NSCLC receiving immunotherapy alone (pembrolizumab) or combined with chemotherapy

Exclusion Criteria:

Any anti-cancer therapy < 6 months prior to study start
Radio- or chemotherapy against lung cancer <2 years before study start
Previous treatment with immunotherapy
Patients with mutations with specific treatment (i.e. EGFR, ALK, Ros1)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

NSCLC patients With Advanced disease elligible for routine treatment With immunotherapy alone or in combination With chemotherapy.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ragnhild Nome, MD	Oslo University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Olavs University Hospital		Trondheim			Norway

Intervention Browse Module

MeSH Terms

ID	Term
C582435	pembrolizumab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided