OncoMatch/Clinical Trials/NCT06448572
EXL01 in Combination With Nivolumab for Advanced NSCLC Refractory to Immunotherapy.
Is NCT06448572 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies EXL01 for non-small cell lung cancer.
Treatment: EXL01 — As treatment options are limited following progression on anti PD-(L)1 and platinum-based chemotherapy, we propose this trial for patients who have failed to respond or have shown intolerance to standard therapies or for whom no appropriate therapies are known to provide clinical benefit. Considering the strong therapeutic rationale of an association between antineoplastic immunotherapy and EXL01 (single-strain of F. prausnitzii, a bacteria which is a dominant member of the healthy gut microbiota), we propose to assess this combination for NSCLC treatment. This is a pilot, Phase I/II, one-arm, monocentric study evaluating the combination of EXL01 with nivolumab treatment for Non-Small Cell Lung Cancer patients.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: ALK wild-type
Required: BRAF wild-type
Required: EGFR wild-type
Required: HER2 (ERBB2) wild-type
Required: MET wild-type
Required: RET wild-type
Required: ROS1 wild-type
Allowed: KRAS any mutation
Disease stage
Required: Stage INOPERABLE STAGE III NOT AMENABLE TO RADIATION THERAPY OR SURGERY, STAGE IV
Metastatic disease required
inoperable advanced/metastatic NSCLC. (inoperable stage III not amenable to radiation therapy or surgery, stage IV)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy
Must have previously received anti-PD(L)1 agent
Must have received: platinum-based chemotherapy
Must have previously received ... platinum-based chemotherapy
Lab requirements
Blood counts
absolute neutrophil count ≥ 1500/μl; platelets ≥ 100 000/μl; hemoglobin ≥ 9.0 g/dl
Kidney function
creatinine clearance ≥ 50 ml/min
Liver function
total bilirubin ≤ 1.5 x uln; ast and alt ≤ 2.5 x uln (≤ 5 x uln for participants with liver metastasis)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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