Non-Small Cell Lung Carcinoma (NSCLC)Phase 4CPINCT07633613
Pharmacokinetic Study of Pembrolizumab and Its Impact on Immunity and the Tumor Microenvironment, Which May Explain the Efficacy of Post-immunotherapy Chemotherapy.
A Phase 4 study testing Blood sampling and Tumor biopsies for biobank establishment (optional) in people with Non-Small Cell Lung Carcinoma (NSCLC) and Metastatic Head and Neck Squamous Cell Carcinoma, run by Centre Antoine Lacassagne.
Trial summary
This is a single-center pharmacokinetic study evaluating the impact of residual pembrolizumab levels on the efficacy of salvage chemotherapy following immunotherapy in patients with non-small cell lung cancer (NSCLC) or recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC) not amenable to curative… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Carcinoma (NSCLC), Metastatic Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Blood sampling and Tumor biopsies for biobank establishment (optional)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to May 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Patients over 18 years of age
- Patients diagnosed with :
- Non-small cell lung cancer (NSCLC), including adenocarcinoma and squamous cell carcinoma.
- Head and neck squamous cell carcinoma, p16-negative for oropharyngeal tumors.
- Recurrent and/or metastatic tumor not amenable to curative locoregional treatment.
- Disease progression under Pembrolizumab immunotherapy, administered at the standard dose of 200 mg every 3 weeks, as first-line treatment for metastatic disease, regardless of the number of cycles received, either as monotherapy or in combination with chemotherapy, as defined below:
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- For pulmonary adenocarcinomas: i. First-line treatment with Pembrolizumab in combination with a platinum agent (Carboplatin or Cisplatin) and Pemetrexed
- Maintenance therapy with Pembrolizumab, with or without Pemetrexed.
- For pulmonary squamous cell carcinomas: i. First-line treatment with Pembrolizumab in combination with a platinum agent (Carboplatin) and Paclitaxel
- +/- ii. Maintenance therapy with Pembrolizumab alone.
- For head and neck squamous cell carcinomas : i. First-line treatment with Pembrolizumab in combination with a platinum agent (Carboplatin or Cisplatin) ± 5-Fluorouracil (5-FU) or Paclitaxel
- +/- ii. Maintenance therapy with Pembrolizumab alone.
- Eligibility for salvage chemotherapy within standard care:
- For pulmonary adenocarcinomas: weekly Paclitaxel, with or without Bevacizumab.
- For pulmonary squamous cell carcinomas: Gemcitabine monotherapy.
- For head and neck squamous cell carcinomas: weekly Paclitaxel and/or Cetuximab. Standard salvage chemotherapy may be initiated between Day 18 and Day 35 following the last Pembrolizumab injection, at standard doses.
- Measurable disease according to RECIST 1.1 criteria.
- Performance status (PS) 0 to 2.
- Baseline laboratory results meeting the usual criteria permitting initiation of salvage chemotherapy.
- Patients who has voluntarily agreed to participate in the study (including additional blood sampling) and has signed the informed consent form.
- For the subpopulation with accessible tissue biopsy:
- Patient agrees to undergo biopsy,
- INR < 1.5, Platelets > 50000/μL.
- Patients covered by a social security health insurance scheme.
Who cannot join
- History of cancer, except for cancers in complete remission for more than 3 years, fully resected cutaneous basal cell carcinomas, or treated carcinoma in situ or cervical intraepithelial neoplasia (in situ cervical epithelioma),
- Patients participating in another clinical trial for which an exclusion period is specified,
- Minor patients,
- For the subpopulation with accessible tissue biopsy, patients receiving:
- Clopidogrel (hydrogen sulfate) or Prasugrel (hydrochloride) or Ticlopidine (hydrochloride) without the possibility of discontinuation for 5 days,
- Low-molecular-weight heparin (LMWH) without the possibility of dose suspension prior to the procedure,
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- Or Fondaparinux without the possibility of discontinuation,
- Or Abciximab without the possibility of discontinuation for 24 hours and aPTT < 50s and ACT < 150s,
- Or Eptifibatide or Tirofiban hydrochloride monohydrate or Argatroban without the possibility of discontinuation 4 hours before the procedure,
- Or Bivalirudin without the possibility of discontinuation 2-3 hours before the procedure if CrCL > 50 mL/min, or 3-5 hours if CrCL < 50 mL/min,
- Or Dabigatran etexilate without the possibility of discontinuation 2-3 days before the procedure if CrCL > 50 mL/min, or 3-5 days if CrCL < 50 mL/min.
- Vulnerable persons as defined in Articles L1121-5 to L1121-8 :
- Pregnant women, women in labour, and breastfeeding mothers,
- Persons deprived of liberty by judicial or administrative decision, and persons hospitalized without consent under Articles L3212-1 and L3213-1 who do not fall under the provisions of Article L1121-8,
- Persons admitted to a health or social care institution for purposes other than research,
- Adults under legal protection measures or unable to express their consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This is a single-center pharmacokinetic study evaluating the impact of residual pembrolizumab levels on the efficacy of salvage chemotherapy following immunotherapy in patients with non-small cell lung cancer (NSCLC) or recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC) not amenable to curative local treatment.
- Being tested
- Blood sampling, Tumor biopsies for biobank establishment (optional)
- Keywords
- Pembrolizumab, immunotherapy, salvage chemotherapy, pharmacokinetics
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
Patients will be followed according to standard clinical care. Biological samples collected include: (1) pharmacokinetic and extracellular vesicle analyses: 10 mL blood samples in EDTA tubes at 21±3, 35±3, 49±3, and 63±3 days after the last pembrolizumab administration (P1-P4); (2) pharmacogenetic analysis: one baseline 5 mL EDTA blood sample; (3) cytokine and immune cell analyses: at P1 and P4, collection of 2×4 mL lithium heparin tubes, 1×10 mL EDTA tube, and 1×5 mL dry tube.
Tumor biopsies for biobank establishment (optional)Procedure or surgery
Depending on feasibility of the procedure, and at the discretion of the investigator, two biopsies will be performed in 20 consenting patients:
- Biopsy B1: between the last administration of pembrolizumab (Day 0) and before initiation of standard salvage chemotherapy,
- Biopsy B2: after initiation of salvage chemotherapy, at Day 63 ± 7 days after the last administration of pembrolizumab. If chemotherapy is discontinued prematurely, Biopsy B2 may only be performed if the patient has received at least 3 weeks of chemotherapy exposure.
Due to logistical constraints, these biopsies will be proposed to patients followed at CAL. They will be performed primarily in the interventional radiology department of CAL.
| Study group | Role | What they receive |
|---|---|---|
| Residual Pembrolizumab Exposure Assessment | Experimental | Not described Receives: Biological: Blood sampling; Procedure: Tumor biopsies for biobank establishment (optional) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) at 3 months after initiation of salvage chemotherapy (RECIST v1.1)
Objective response rate (ORR) includes the proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST version 1.1 criteria.
Tumor response will be assessed using routine imaging performed during standard clinical follow-up care.
ORR will be analyzed in relation to residual pembrolizumab (anti-PD-1) serum concentration measured 21 days after the last administration of pembrolizumab (P1), immediately prior to initiation of salvage chemotherapy.
Measured: 3 months after initiation of salvage chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study startOct 2026 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung Carcinoma (NSCLC)Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Antoine Lacassagne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633613
- Sponsor's protocol ID
- 2023/60
- Other IDs
- 2026-526866-26-00
- Acronym
- CPI
- Status last verified
- Sep 2026
- First submitted
- 29 May 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of Pembrolizumab and Its Impact on Immunity and the Tumor Microenvironment, Which May Explain the Efficacy of Post-immunotherapy Chemotherapy.
- ClinicalTrials.gov ID
- NCT07633613
- Acronym / sponsor ID
- CPI / 2023/60
- Keywords
- Pembrolizumab, immunotherapy, salvage chemotherapy, pharmacokinetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Centre Antoine LacassagneUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 8 Jun 2026 (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 is a single-center pharmacokinetic study evaluating the impact of residual pembrolizumab levels on the efficacy of salvage chemotherapy following immunotherapy in patients with non-small cell lung cancer (NSCLC) or recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC) not amenable to curative local treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Residual Pembrolizumab Exposure Assessment | Experimental | Biological: Blood sampling, Procedure: Tumor biopsies for biobank establishment (optional) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Patients over 18 years of age
- Patients diagnosed with :
- Non-small cell lung cancer (NSCLC), including adenocarcinoma and squamous cell carcinoma.
- Head and neck squamous cell carcinoma, p16-negative for oropharyngeal tumors.
- +/- ii. Maintenance therapy with Pembrolizumab alone.
Key exclusion criteria (16 listed)
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 |
|---|---|---|
| Blood samplingPatients will be followed according to standard clinical care. Biological samples collected include: (1) pharmacokinetic and extracellular vesicle analyses: 10 mL blood samples in EDTA tubes at 21±3, 35±3, 49±3, and 63±3 days after the last pembrolizumab administration (P1-P4); (2) pharmacogenetic analysis: one baseline 5 mL EDTA blood sample; (3) cytokine and immune cell analyses: at P1 and P4, collection of 2×4 mL lithium heparin tubes, 1×10 mL EDTA tube, and 1×5 mL dry tube. | Biological | Residual Pembrolizumab Exposure Assessment |
| Tumor biopsies for biobank establishment (optional)Depending on feasibility of the procedure, and at the discretion of the investigator, two biopsies will be performed in 20 consenting patients: * Biopsy B1: between the last administration of pembrolizumab (Day 0) and before initiation of standard salvage chemotherapy, * Biopsy B2: after initiation of salvage chemotherapy, at Day 63 ± 7 days after the last administration of pembrolizumab. If chemotherapy is discontinued prematurely, Biopsy B2 may only be performed if the patient has received at least 3 weeks of chemotherapy exposure. Due to logistical constraints, these biopsies will be proposed to patients followed at CAL. They will be performed primarily in the interventional radiology department of CAL. | Procedure or surgery | Residual Pembrolizumab Exposure Assessment |
Primary outcome
Objective response rate (ORR) at 3 months after initiation of salvage chemotherapy (RECIST v1.1)
Time frame: 3 months after initiation of salvage chemotherapy
Objective response rate (ORR) includes the proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST version 1.1 criteria. Tumor response will be assessed using routine imaging performed during standard clinical follow-up care. ORR will be analyzed in relation to residual pembrolizumab (anti-PD-1) serum concentration measured 21 days after the last administration of pembrolizumab (P1), immediately prior to initiation of salvage chemotherapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blood sampling and Tumor biopsies for biobank establishment (optional) in people with Non-Small Cell Lung Carcinoma (NSCLC) and Metastatic Head and Neck Squamous Cell Carcinoma, run by Centre Antoine Lacassagne.
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 24 inclusion and 16 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: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marine SIRVENT (+33 4 92 03 17 78, DRCI-Promotion@nice.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) at 3 months after initiation of salvage chemotherapy (RECIST v1.1) (time frame: 3 months after initiation of salvage chemotherapy). 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 15 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.