OncoMatch/Clinical Trials/NCT06080776
SH-1028 Tablets Versus Placebo as Adjuvant Therapy in Resected Stage II-IIIB NSCLC With Sensitizing EGFR Mutations
Is NCT06080776 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies SH-1028 tablets for non-small cell lung cancer.
Treatment: SH-1028 tablets — To assess the efficacy and safety of SH-1028 tablets versus placebo in stage II-IIIB non-small cell lung cancer (NSCLC) patients with sensitizing epidermal growth factor receptor (EGFR) mutations, following complete tumor resection, with or without adjuvant chemotherapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR exon 19 deletion
Patients must harbor one of the two common sensitizing EGFR mutations (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M, the mutations should be confirmed by the central laboratory.
Required: EGFR L858R
Patients must harbor one of the two common sensitizing EGFR mutations (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M, the mutations should be confirmed by the central laboratory.
Disease stage
Required: Stage II, IIIA, IIIB (ONLY T3N2M0)
Patients with postoperative pathological confirmation of stage II, IIIA and IIIB (only T3N2M0) are eligible.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: EGFR tyrosine kinase inhibitor
Treatment with any of the following (except for standard platinum-based adjuvant chemotherapy), including any EGFR-TKI, systemic chemotherapy, immunotherapy, targeted therapy and anti-tumor traditional Chinese medicine therapy.
Cannot have received: systemic chemotherapy
Exception: except for standard platinum-based adjuvant chemotherapy
Treatment with any of the following (except for standard platinum-based adjuvant chemotherapy), including any EGFR-TKI, systemic chemotherapy, immunotherapy, targeted therapy and anti-tumor traditional Chinese medicine therapy.
Cannot have received: immunotherapy
Treatment with any of the following (except for standard platinum-based adjuvant chemotherapy), including any EGFR-TKI, systemic chemotherapy, immunotherapy, targeted therapy and anti-tumor traditional Chinese medicine therapy.
Cannot have received: targeted therapy
Treatment with any of the following (except for standard platinum-based adjuvant chemotherapy), including any EGFR-TKI, systemic chemotherapy, immunotherapy, targeted therapy and anti-tumor traditional Chinese medicine therapy.
Cannot have received: anti-tumor traditional Chinese medicine therapy
Treatment with any of the following (except for standard platinum-based adjuvant chemotherapy), including any EGFR-TKI, systemic chemotherapy, immunotherapy, targeted therapy and anti-tumor traditional Chinese medicine therapy.
Lab requirements
Blood counts
Absolute neutrophil count (ANC）≥1.5×10^9 /L; Platelet count ≥100×10^9 /L; Hemoglobin ≥90 g/L
Kidney function
Creatinine ≤ 1.5 × ULN concurrent with creatinine clearance ≥ 50 mL/min (measured or calculated by the Cockcroft-Gault equation); confirmation of creatinine clearance is only required when creatinine is ≤ 1.5×ULN
Liver function
ALT ≤ 2.5 × ULN if no demonstrable liver metastases or ≤ 5 × ULN in the presence of liver metastases; AST ≤ 2.5 × ULN if no demonstrable liver metastases or ≤ 5 × ULN in the presence of liver metastases; Total bilirubin ≤ 1.5 × ULN if no liver metastases or ≤ 3 × ULN in the presence of documented Gilbert's Syndrome or liver metastases
Cardiac function
Mean resting corrected QT interval (QTcF) > 470 msec obtained from 3 ECGs; Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG; Any factors that increase the risk of QTc prolongation or risk of arrhythmic events; Left ventricular ejection fraction (LVEF) <50%
Adequate bone marrow reserve or organ function, as demonstrated by the following laboratory values... (see full criteria for details). Any of the following cardiac criteria: Mean resting corrected QT interval (QTcF) > 470 msec... LVEF <50%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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