At a glance
ClinicalIndex Comparison RecordPhase 3Recruiting· 242 target
Drug / intervention
SH-1028 tablets +1 moredrug
Likely dose
SH-1028 tablets 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating SH-1028 tablets and Placebo SH-1028 tablets for Non-small Cell Lung Cancer. Currently recruiting, targeting 242 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-small Cell Lung Cancer
CountriesChina
Collaborators--
Timeline
Phase 3Recruiting
20242025202620272028202920302031
Enrollment StartMay 2023
First PostedOct 2023
TodayJul 2026
Primary CompletionFeb 2028
Study CompletionFeb 2031
First PostedOct 12, 2023
Enrollment StartMay 11, 2023
Primary CompletionFeb 1, 2028
Study CompletionFeb 1, 2031
TodayJul 1, 2026
Enrollment to primary: 4.7 yearsPosted 2.7 years agoPrimary completion in 1.6 years
Interventions
SH-1028 tabletsdrug
The initial dose of SH-1028 tablets is 200 mg once daily.
Placebo SH-1028 tabletsdrug
Placebo SH-1028 tablets.