Loading clinical trials...

RECRUITINGPHASE3

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

NCT06080776•Nanjing Sanhome Pharmaceutical, Co., Ltd.

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female, aged at least 18 years, younger than 75 years.
•Histologically confirmed diagnosis of primary non-small lung cancer (NSCLC) on predominantly non-squamous histology.
•Before surgery or randomization, MRI or CT scan of the brain and bone scan must be done to exclude metastases.
•Complete resection (R0) and systematic lymphadenectomy are mandatory: all surgical margins must be negative for tumor, and there should be no extranodal invasion of the mediastinal lymph nodes or marginal lymph nodes.
•Patients with postoperative pathological confirmation of stage II, IIIA and IIIB (only T3N2M0) are eligible.
•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.
•Complete recovery from surgery and standard post-operative therapy (if applicable) at the time of randomization.
•A ECOG performance status equal to 0-1 with a minimum life expectancy of 12 weeks and no deterioration over the past 2 weeks.
•Adequate bone marrow reserve or organ function, as demonstrated by the following laboratory values (no corrective treatment allowed within one week before blood sampling):
•1. Absolute neutrophil count (ANC）≥1.5×10\^9 /L
+11 more criteria

Exclusion Criteria

•Patients with unresectable or metastatic lesions, residual lesions after surgery, or those who have had only segmentectomies or wedge resection.
•Giant mediastinal lymph node metastasis at a single station or mediastinal lymph node fusion into a cluster at multiple stations; lesions invade the heart, aorta, esophagus, or pulmonary veins; Carcinoma of superior lung sulci.
•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.
•Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study drug.
•The patient is currently using (or cannot discontinue at least 1 week before the first dose of study drug) a drug or herbal supplement known as a potent inhibitor or inducer of CYP3A4.
•Severe infections occurred within 4 weeks or active infections that received therapeutic intravenous or oral antibiotics within 2 weeks before the first dose.
•Any evidence of active infection (including hepatitis B, hepatitis C, and human immunodeficiency virus).
•Patients received continuous steroid therapy for more than 30 days within 30 days before the first dose; require long-term (≥30 days) steroid therapy; with acquired or congenital immunodeficiency diseases or have a history of organ transplantation.
•Severe or uncontrolled systemic diseases, including hypertension or diabetes.
•Any of the following cardiac criteria:
+14 more criteria

Locations (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

May 11, 2023

Primary Completion Date

February 1, 2028

Completion Date

February 1, 2031

Last Updated

October 12, 2023

Enrollment

242

ESTIMATED participants

Conditions

Non-small Cell Lung Cancer

Interventions

SH-1028 tablets

DRUG

Placebo SH-1028 tablets

DRUG

Contacts

Kun Cao

CONTACT

86-15776680370 caokun@sanhome.com

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

View study

RECRUITINGPHASE3

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 12, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)