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

NCT04557007 | Terminated FDA Drug

• 1 other identifier: 2017/9660
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

• Objective response

  Radiological response (Partial response/stable disease/Complete response)

  3 months

Secondary Outcomes (4)

• Adverse events

  2 years

• PD-1 Expression on CD-8 T-cells

  First 3 months

• Overall survival

  5 years observation

• Progression-Free survival

  1 year

Other Outcomes (1)

• Pembrolizumab clearance

  3 months

Study Arms (1)

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

Pembrolizumab DRUG

Drug trough-level will be measured in patients on Pembrolizumab with or without additional chemotherapy in routine care.

Treatment-naive NSCLC patients

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Oslo University Hospital: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

St Olavs University Hospital

Trondheim, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and full blood samples

MeSH Terms

Interventions

pembrolizumab

Study Officials

• Ragnhild Nome, MD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 21, 2020
• Study Start: September 1, 2020
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

NO (1)