EXL01 in Combination With Nivolumab for Advanced NSCLC Refractory to Immunotherapy.

Inclusion Criteria

• •1. Patients (male or female) ≥18 years old.
• •2. ECOG Performance status (PS) 0-1 (WHO).
• •3. Histologically or cytologically documented inoperable advanced/metastatic NSCLC. (inoperable stage III not amenable to radiation therapy or surgery, stage IV)
• •4. No alterations of key driver oncogenes including EGFR (mutations), ALK (fusions), ROS1 (fusions), MET (METex14 mutations), HER2 (exon 20 insertions), RET (fusions), or BRAF (V600E mutations). KRAS mutations are allowed.
• •5. Must have previously received anti-PD(L)1 agent and platinum-based chemotherapy, either concomitantly or sequentially. Last dose to have been administered more than 15 days prior to first dose of study drug.
• •6. Must have progressed within 6 months after first dose of anti-PD(L)1 given either alone or in combination with platinum-based chemotherapy.
• •7. Must have received all validated available standard therapies.
• •8. Measurable disease according to iRECIST 1.1.
• •9. Adequate hematological, renal and liver functions within 72 hours before the first dose of study treatment:
• •* Absolute Neutrophil Count ≥ 1500/μL
• •* Platelets ≥ 100 000/μL
• •* Hemoglobin ≥ 9.0 g/dL
• •* Creatinine Clearance ≥ 50 mL/min
• •* Total Bilirubin ≤ 1.5 x ULN
• •* AST and ALT ≤ 2.5 x ULN (≤ 5 x ULN for participants with liver metastasis)