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.
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.
For pulmonary squamous cell carcinomas: Gemcitabine monotherapy.
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,
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,
Single group
Blood sampling
Biological/VaccinePatients 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/SurgeryDepending 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.
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.
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