NCT06080776

SH-1028 Tablets Versus Placebo as Adjuvant Therapy in Resected Stage II-IIIB NSCLC With Sensitizing EGFR Mutations

A Phase III, Double-blind, Randomised Study of SH-1028 Tablets Versus Placebo as Adjuvant Therapy in Resected Stage II-IIIB Non-Small Cell Lung Cancer With Sensitizing EGFR Mutations

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 242 (estimated)
• Sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a Phase III, multi-center, double-blind, randomized study assessing the efficacy and safety of SH-1028 tablets (200 mg orally, once daily) versus placebo in stage II-IIIB NSCLC with sensitizing EGFR mutations, following complete tumor resection, with or without adjuvant chemotherapy (2\~4 cycles of platinum-based doublet).

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	SH-1028 tablets	The initial dose of SH-1028 tablets is 200 mg once daily.
DRUG	Placebo SH-1028 tablets	Placebo SH-1028 tablets.

Timeline

• Start date: 2023-05-11
• Primary completion: 2028-02-01
• Completion: 2031-02-01
• First posted: 2023-10-12
• Last updated: 2023-10-12

Locations

1 site across 1 country: China