OncoMatch/Clinical Trials/NCT06388031
ICI Rechallenge for Advanced NSCLC With Long-Term Response to First-Line ICI
Is NCT06388031 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Immune checkpoint inhibitor for non-small cell lung cancer.
Treatment: Immune checkpoint inhibitor — An exploratory phase II trial of immune checkpoint inhibitors (ICIs, anti-PD-1/anti-PD-L1) as second-line treatment with advanced non-small cell lung cancer (NSCLC) who had long-term response to first-line immunotherapy (with or without chemotherapy). This study aims to evaluate efficacy and safety of ICI rechallenge in long-term responders to prior ICI. Furthermore, it seeks to identify biomarkers capable of predicting the efficacy of immunotherapy and prognosis.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR exon 19 deletion
Known sensitive EGFR mutation (EGFR exon19 del or EGFR exon21 L858R)
Required: EGFR L858R
Known sensitive EGFR mutation (EGFR exon19 del or EGFR exon21 L858R)
Required: ALK rearrangement
ALK rearrangement
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anti-PD-1 therapy (pembrolizumab, nivolumab, tislelizumab, toripalimab, sintilimab, camrelizumab) — first-line
Previous treated with first-line immunotherapy (immunotherapeutic agents include currently marketed anti-PD-L1 or anti-PD-1 monoclonal antibodies: pembrolizumab, nivolumab, atezolizumab, durvalumab, tislelizumab, toripalimab, sintilimab, camrelizumab, etc.; investigational drugs not yet marketed need discussion with the study team prior to enrollment; with or without platinum-based doublet chemotherapy) for at least 35 cycles or disease stability confirmed by imaging assessment for at least 2 years, and disease progression
Must have received: anti-PD-L1 therapy (atezolizumab, durvalumab) — first-line
Previous treated with first-line immunotherapy (immunotherapeutic agents include currently marketed anti-PD-L1 or anti-PD-1 monoclonal antibodies: pembrolizumab, nivolumab, atezolizumab, durvalumab, tislelizumab, toripalimab, sintilimab, camrelizumab, etc.; investigational drugs not yet marketed need discussion with the study team prior to enrollment; with or without platinum-based doublet chemotherapy) for at least 35 cycles or disease stability confirmed by imaging assessment for at least 2 years, and disease progression
Cannot have received: systemic therapy
Received two or more prior systemic therapies
Lab requirements
Blood counts
absolute neutrophil count (anc) ≥1500/μl; platelets ≥100000/μl; hemoglobin ≥9.0g/dl
Kidney function
serum creatinine ≤1.5×uln or calculated creatinine clearance (crcl) ≥60 ml/min (using cock-gault formula)
Liver function
total bilirubin ≤1.5 ×uln or, for subjects with total bilirubin levels >1.5×uln, direct bilirubin within normal limits; ast (sgot) and alt (sgpt) ≤2.5×uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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