OncoMatch/Clinical Trials/NCT05886439
LK101 Combined With PD-1 or PD-L1 Monoclonal Antibody in the Treatment of Lung Cancer
Is NCT05886439 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including LK101 and Pembrolizumab for lung cancer.
Treatment: LK101 · Pembrolizumab · Durvalumab · Tislelizumab — This is a open lable, single-center phase Ib/IIa study for patients with local advanced or metastastic NSCLC or ES-SCLC, who failed with previous anti-PD-1/PD-L1 therapy (cohort 1 and cohort 2) and for patients with ocal advanced or metastastic NSCLC received the first line treatment (cohort 3). The aim is to observe and evaluate the safety, tolerability and efficacy of LK101 injection combined with pembrolizumab, durvalumab or tislelizumab respectively in the incurable NSCLC and SCLC.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression
Cohort 3: ...have PD-L1 expression
Disease stage
Required: Stage III, IV, EXTENSIVE
locally advanced or metastastic Non-small lung carcinoma (NSCLC)... extensive small-cell lung carcinoma (ES-SCLC); At least one measurable lesion according to RECIST 1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy
Cohort 1 and Cohort 2 required patients progressed/recurrenced after anti-PD-1/PD-L1 treatment
Must have received: anti-PD-L1 therapy
Cohort 1 and Cohort 2 required patients progressed/recurrenced after anti-PD-1/PD-L1 treatment
Must have received: chemotherapy
Cohort 3: ...who have not experienced disease progression after receiving chemotherapy combined with an anti-PD-1 therapy
Must have received: anti-PD-1 therapy
Cohort 3: ...who have not experienced disease progression after receiving chemotherapy combined with an anti-PD-1 therapy
Cannot have received: therapeutic tumor vaccine
Patients who have received therapeutic tumor vaccine products (including peptide vaccine, mRNA vaccine, DC vaccine, etc.)
Cannot have received: allogeneic hematopoietic stem cell transplantation
Patients who have recewived allogeneic hematopoietic stem cell transplantation or organ transplantation
Cannot have received: organ transplantation
Patients who have recewived allogeneic hematopoietic stem cell transplantation or organ transplantation
Lab requirements
Blood counts
ANC ≥ 1.5x10^9/L; platelets ≥ 90x10^9/L; hemoglobin > 9g/dL; no blood transfusion or blood component treatment and without G-CSF in past 14 days
Kidney function
Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50ml; patients with urinary protein ≥ ++ and confirmed 24-hour urinary protein quantity > 1.0g
Liver function
Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN with liver metastasis); AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN with liver metastasis)
Cardiac function
Mean resting QTc > 470 ms; LVEF ≤ 50%; NYHA ≥ 2; serious arrhythmia; poorly controlled hypertension; other serious heart disease
For adequate organ function, the patients need to meet the following laboratory indexes: ... (see full criteria for details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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