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OncoMatch/Clinical Trials/NCT04767009

SBRT for Oligo-residual NSCLC After Treatment With PD-1/PD-L1 Immune Checkpoint Inhibitors

Is NCT04767009 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies PD-1/PD-L1 inhibitors (alone or in combination with chemotherapy) for nsclc stage iv.

Phase 2RecruitingFudan UniversityNCT04767009Data as of May 2026

Treatment: PD-1/PD-L1 inhibitors (alone or in combination with chemotherapy)Despite the impressive response rate to PD-1/PD-L1 immune checkpoint inhibitors, resistance inevitably develops in most patients. Stereotactic body radiation therapy (SBRT) plays a growing role in the management of oligometastatic disease. This study aims to evaluate the efficacy and safety of SBRT for oligo-residual NSCLC after effective treatment with PD-1/PD-L1 inhibitors.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: ALK wild-type

Required: EGFR wild-type

Required: ROS1 wild-type

Disease stage

Required: Stage IV

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: anti-PD-1/PD-L1 therapy

Oligo-residual disease after effective treatment with PD-1/PD-L1 inhibitors

Cannot have received: tumor vaccine

Patients who have received tumor vaccine

Cannot have received: live, attenuated vaccine

Exception: Influenza vaccination is permitted only during influenza season, while live, attenuated influenza vaccine such as FluMist is not allowed.

administration of live, attenuated vaccine within 4 weeks before the start of treatment

Lab requirements

Blood counts

hemoglobin ≥80g/L, WBC ≥ 4.0 x 10^9/L or neutrophil count ≥ 1.5 x 10^9/L, platelet count ≥ 100 x 10^9/L

Kidney function

serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min

Liver function

total bilirubin < 1.5 x ULN (if >1.5 x ULN, direct bilirubin must ≤ ULN), AST and ALT ≤2.5 ULN

Adequate organ function within 1 week prior to enrollment: Adequate bone marrow function: hemoglobin ≥80g/L, WBC ≥ 4.0 x 10^9/L or neutrophil count ≥ 1.5 x 10^9/L, and platelet count ≥ 100 x 10^9/L; Adequate hepatic function: total bilirubin < 1.5 x ULN. Note: If total bilirubin is > 1.5 x ULN, direct bilirubin must ≤ ULN, AST and ALT ≤2.5 ULN; Adequate renal function: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min;

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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