RecruitingPhase 3NCT06080776

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


Sponsor

Nanjing Sanhome Pharmaceutical, Co., Ltd.

Enrollment

242 participants

Start Date

May 11, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a targeted pill called SH-1028 can help prevent lung cancer from coming back after surgery in patients whose tumors have a specific genetic mutation (EGFR). It compares the pill to a placebo (sugar pill) taken daily after surgery. **You may be eligible if...** - You are 18 to 74 years old - You had surgery to completely remove non-small cell lung cancer (a specific type) - Your cancer was stage II, IIIA, or a specific form of IIIB after surgery - Your tumor has a specific EGFR gene mutation (a genetic change that makes the cancer sensitive to certain drugs) - You have recovered well from surgery - Your blood tests show your organs are functioning adequately **You may NOT be eligible if...** - Your cancer could not be fully removed or has spread - You have previously received certain cancer treatments including EGFR-targeted drugs, chemotherapy, or immunotherapy after surgery - You have serious heart conditions, severe liver disease, or uncontrolled infections - You have a history of a specific type of lung scarring (interstitial lung disease) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSH-1028 tablets

The initial dose of SH-1028 tablets is 200 mg once daily.

DRUGPlacebo SH-1028 tablets

Placebo SH-1028 tablets.


Locations(1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

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NCT06080776


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