OncoMatch/Clinical Trials/NCT05255302
De-escalation Immunotherapy mAintenance Duration Trial for Stage IV Lung Cancer Patients With Disease Control After Chemo-immunotherapy Induction
Is NCT05255302 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments including Pembrolizumab before randomization and Chemotherapy for metastatic nsclc.
Treatment: Pembrolizumab before randomization · Chemotherapy · Pemetrexed · Pembrolizumab after randomization — Immunotherapeutic approaches recently have demonstrated clinical efficacy in several cancer types, including melanoma and NSCLC. As a matter of fact, first registration trials of immune-checkpoints inhibitors (ICI) in second-line settings (pembrolizumab as well as nivolumab or atezolizumab) had stated that ICI could be continued until disease progression or not tolerable toxicity, up to 5 years. This is only for the first-line registration studies that the arbitrary maximal duration of treatment of 2 years was set up by the Companies sponsoring such trials. The aim is to study a de-escalation scheme of treatment from 2 years of immunotherapy to 6 months (27-weeks), in patients with controlled disease.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression
PD-L1 tumor content as assessed locally by the investigator center.
Excluded: EGFR activating mutation
Known EGFR activating tumor mutation (deletion LREA in exon 19, L858R ou L861X mutations in exon 21, G719A/S mutation in exon 18, exon 20 insertion)
Excluded: HER2 (ERBB2) exon 20 insertion
HER2 exon 20 insertion (either tissue or plasma cfDNA mutation)
Excluded: ALK rearrangement
Known ALK, ROS1, Ret, NTRK, NRG1 gene rearrangement
Excluded: ROS1 rearrangement
Known ALK, ROS1, Ret, NTRK, NRG1 gene rearrangement
Excluded: RET rearrangement
Known ALK, ROS1, Ret, NTRK, NRG1 gene rearrangement
Excluded: NTRK1 rearrangement
Known ALK, ROS1, Ret, NTRK, NRG1 gene rearrangement
Excluded: NTRK2 rearrangement
Known ALK, ROS1, Ret, NTRK, NRG1 gene rearrangement
Excluded: NTRK3 rearrangement
Known ALK, ROS1, Ret, NTRK, NRG1 gene rearrangement
Excluded: NRG1 rearrangement
Known ALK, ROS1, Ret, NTRK, NRG1 gene rearrangement
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: EGFR inhibitor
No prior systemic anticancer therapy (including EGFR or ALK inhibitors) given as primary therapy for advanced or metastatic disease.
Cannot have received: ALK inhibitor
No prior systemic anticancer therapy (including EGFR or ALK inhibitors) given as primary therapy for advanced or metastatic disease.
Cannot have received: systemic anticancer therapy
No prior systemic anticancer therapy (including EGFR or ALK inhibitors) given as primary therapy for advanced or metastatic disease.
Cannot have received: anti-PD-1 therapy
Previous treatment with anti-PD-1, anti-PD-L1, Anti-CTLA4 or any ICI antibody
Cannot have received: anti-PD-L1 therapy
Previous treatment with anti-PD-1, anti-PD-L1, Anti-CTLA4 or any ICI antibody
Cannot have received: anti-CTLA-4 therapy
Previous treatment with anti-PD-1, anti-PD-L1, Anti-CTLA4 or any ICI antibody
Cannot have received: immune checkpoint inhibitor
Previous treatment with anti-PD-1, anti-PD-L1, Anti-CTLA4 or any ICI antibody
Cannot have received: chemotherapy
Exception: if a patient has a lung adenocarcinoma, previous cisplatin treatment for another cancer type with squamous histology (Head and Neck, bladder) may be allowed provided the sponsor accepts, and provided blood tests are normal
Previous treatment with chemotherapy for lung cancer. However, if a patient has a lung adenocarcinoma, previous cisplatin treatment for another cancer type with squamous histology (Head and Neck, bladder) may be allowed provided the sponsor accepts, and provided blood tests are normal (see above).
Lab requirements
Blood counts
neutrophils≥ 1500/mm3 ; platelets ≥100 000/mm3 ; Hemoglobin≥ 9g/dL
Kidney function
Creatinine Clearance ≥ 45 mL/min (Cockcroft or MDRD or CKD-epi)
Liver function
AST and ALT < 3x ULN, total bilirubin < 2xULN (patients with hepatic metastases or Gilbert's syndrome must have AST and ALT ≤ 5 x ULN and a baseline total bilirubin ≤ 2xULN)
Adequate biological functions: Creatinine Clearance ≥ 45 mL/min (Cockcroft or MDRD or CKD-epi); neutrophils≥ 1500/mm3 ; platelets ≥100 000/mm3 ; Hemoglobin≥ 9g/dL ; AST and ALT< 3x ULN, total bilirubin < 2xULN (patients with hepatic metastases or Gilbert's syndrome must have AST and ALT ≤ 5 x ULN and a baseline total bilirubin ≤ 2xULN).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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