OncoMatch/Clinical Trials/NCT06388031
ICI Rechallenge for Advanced NSCLC With Long-Term Response to First-Line ICI
Is NCT06388031 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06388031 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic therapy disqualifies patients from enrollment.
Does this trial require EGFR?
Yes, EGFR exon 19 deletion is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR L858R is a required biomarker for enrollment.
Does this trial require ALK?
Yes, ALK rearrangement is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or IV is required.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify