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OncoMatch/Clinical Trials/NCT06969612

A Study on the Efficacy and Safety of Golidocitinib Combined With Tislelizumab and Chemotherapy as First-line Treatment for Advanced NSCLC

Is NCT06969612 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for nsclc (advanced non-small cell lung cancer).

Phase 1RecruitingPeking University Cancer Hospital & InstituteNCT06969612Data as of May 2026

Treatment: Tislelizumab · Pemetrexed · Cisplatin · Carboplatin · Paclitaxel · Albumin Paclitaxel · GolidocitinibThe goal of this clinical trial is to learn if golidocitinib combined with tislelizumab and chemotherapy works in advanced NSCLC with PD-L1≥1%. The main question it aims to answer is: Does the combination of golidocitinib with tislelizumab and chemotherapy can prolong the progression-free survival of patients with advanced NSCLC? Participants will: Take tislelizumab and chemotherapy for 2 cycles; and then take tislelizumab and golidocitinib for 2 cycles; after cycle 5, patients receive tislelizumab and chemotherapy until the patients were intolerant or the disease progressed.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: EGFR exon 19 deletion

Histology of lung adenocarcinoma confirmed the presence of EGFR19 deletion or L858R mutation and ALK, ROS-1 fusion gene mutation (non-adenocarcinoma patients are not required to undergo mandatory genetic testing).

Required: EGFR L858R mutation

Histology of lung adenocarcinoma confirmed the presence of EGFR19 deletion or L858R mutation and ALK, ROS-1 fusion gene mutation (non-adenocarcinoma patients are not required to undergo mandatory genetic testing).

Required: ALK fusion gene mutation

Histology of lung adenocarcinoma confirmed the presence of EGFR19 deletion or L858R mutation and ALK, ROS-1 fusion gene mutation (non-adenocarcinoma patients are not required to undergo mandatory genetic testing).

Required: ROS1 fusion gene mutation

Histology of lung adenocarcinoma confirmed the presence of EGFR19 deletion or L858R mutation and ALK, ROS-1 fusion gene mutation (non-adenocarcinoma patients are not required to undergo mandatory genetic testing).

Required: PD-L1 (CD274) PD-L1(22C3) ≥1% (≥1%)

PD-L1(22C3) ≥1%

Disease stage

Required: Stage IIIB, IIIC, IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic chemotherapy

Cannot have received: biological therapy

Cannot have received: targeted therapy

Cannot have received: immunotherapy

Lab requirements

Blood counts

ANC ≥ 1.5×10^9/L (no growth factor); platelets ≥ 100×10^9/L (no growth factor or transfusion); hemoglobin ≥ 9 g/dL (no transfusion or erythropoietin)

Kidney function

Blood creatinine ≤ 1.5 × ULN, or creatinine clearance rate ≥ 50 mL/min (Cockcroft-Gault or 24h urine)

Liver function

Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN if Gilbert syndrome); ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN with liver metastases)

The bone marrow reserve and organ system functional reserve are sufficient...see full details above

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

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