NSCLCOncomabsNCT04557007
Drug Concentration Monitoring of Pembrolizumab in Non-Small Cell Lung Cancer Patients
An observational study of NSCLC, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- Pembrolizumab
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2020to 1 Oct 2022
- Phase
- Observational
- 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
Study population: NSCLC patients With Advanced disease elligible for routine treatment With immunotherapy alone or in combination With chemotherapy.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drug Concentration Monitoring of Pembrolizumab in Treatment-naive Non-Small Cell Lung Cancer Patients
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
- Being tested
- Pembrolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Drug trough-level will be measured in patients on Pembrolizumab with or without additional chemotherapy in routine care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response
Radiological response (Partial response/stable disease/Complete response)
Measured: 3 months
Secondary outcomes (4)
Adverse events
Adverse events >= 3
Measured: 2 years
PD-1 Expression on CD-8 T-cells
Proliferation of PD-1 Expression CD-8 T-cells
Measured: First 3 months
Overall survival
Overall survival related to drug trough-level
Measured: 5 years observation
Progression-Free survival
Radiological evaluation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start1 Sep 2020
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Why it stopped: Difficulty recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Principal investigator, Ragnhild Nome, Oslo University Hospital
- Investigators
- Ragnhild Nome, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557007
- Sponsor's protocol ID
- 2017/9660
- Acronym
- Oncomabs
- Status last verified
- Jan 2026
- First submitted
- 2 Sep 2020
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Concentration Monitoring of Pembrolizumab in Treatment-naive Non-Small Cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT04557007
- Acronym / sponsor ID
- Oncomabs / 2017/9660
- Conditions
- NSCLC
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 21 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment-naive NSCLC patients | – | Drug: PembrolizumabTreatment-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NSCLC patients With Advanced disease elligible for routine treatment With immunotherapy alone or in combination With chemotherapy.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabDrug trough-level will be measured in patients on Pembrolizumab with or without additional chemotherapy in routine care. | Drug | Treatment-naive NSCLC patients |
Primary outcome
Objective response
Time frame: 3 months
Radiological response (Partial response/stable disease/Complete response)
4 secondary outcomes
Adverse events
Time frame: 2 years
PD-1 Expression on CD-8 T-cells
Time frame: First 3 months
Overall survival
Time frame: 5 years observation
Progression-Free survival
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Difficulty recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ragnhild Nome, MD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC, run by Oslo University Hospital at 1 site in Norway.
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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 29 Jan 2026. 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 Norway. 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.
Are results available for this study?
The study was stopped early (reason given: Difficulty recruiting). Results are not available in the source record.
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?
Objective response (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2026.