MedTrace Logo

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

NCT06080776 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2023-10-12

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Nanjing Sanhome Pharmaceutical, Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Caicun Zhou, Professor · Shanghai Pulmonary Hospital, Shanghai, China

  • Daqiang Sun, Professor · Tianjin Chest Hospital, Tianjin, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-11
Primary Completion
2028-02-01
Completion
2031-02-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06080776 on ClinicalTrials.gov