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

NCT06080776 | Recruiting Phase 3

• 1 other identifier: SHC013-III-02
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief 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

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Disease free survival (DFS) assessed by Independent Review Committee (IRC)

  Disease-free survival is defined as the time from randomization until the date of the recurrence of tumor or death. The primary endpoint of DFS was based on the assessment of IRC.

  From the time of randomization to the recurrence of tumor or death, through study completion, an average of 5 years

Secondary Outcomes (6)

• Disease free survival (DFS) assessed by investigators

  From the time of randomization to the recurrence of tumor or death, through study completion, an average of 5 years

• DFS rate at 2, 3 and 5 years assessed by IRC

  From the time of randomization to the recurrence of tumor or death, up to 5 years

• Overall survival (OS)

  From the time of randomization to death, through study completion, an average of 5 years

• OS rate at 5 years

  From the time of randomization to death, up to 5 years

• Incidence rate of adverse events (AEs)

  From the screening period to 28 days after treatment discontinuation

Study Arms (2)

SH-1028 tablets

EXPERIMENTAL

Drug: SH-1028 tablets

Placebo SH-1028 tablets

PLACEBO COMPARATOR

Drug: Placebo SH-1028 tablets

Interventions

SH-1028 tablets DRUG

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

SH-1028 tablets

Placebo SH-1028 tablets DRUG

Placebo SH-1028 tablets.

Placebo SH-1028 tablets

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• Absolute neutrophil count (ANC）≥1.5×10\^9 /L
• Platelet count ≥100×10\^9 /L
• Hemoglobin ≥90 g/L
• Alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN) if no demonstrable liver metastases or ≤ 5 × ULN in the presence of liver metastases
• Aspartate aminotransferase (AST) ≤ 2.5 × ULN if no demonstrable liver metastases or ≤ 5 × ULN in the presence of liver metastases
• Total bilirubin (TBL) ≤ 1.5 × ULN if no liver metastases or ≤ 3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases

You may not qualify if:

• 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:
• Mean resting corrected QT interval (QTcF) \> 470 msec obtained from 3 electrocardiograms (ECGs), using the Screening clinic's ECG machine and Fridericia's formula for QT interval correction.
• Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG (e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval \>250 msec).
• Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval.
• Left ventricular ejection fraction (LVEF) \<50%.
• Receiving or requiring drugs known to prolong the QT interval or possibly cause tip torsion ventricular tachycardia during the study.

Sponsors & Collaborators

• Nanjing Sanhome Pharmaceutical, Co., Ltd.: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

SH-1028

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Caicun Zhou, Professor

  Shanghai Pulmonary Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

• Daqiang Sun, Professor

  Tianjin Chest Hospital, Tianjin, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kun Cao

CONTACT

86-15776680370; caokun@sanhome.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: October 12, 2023
• Study Start: May 11, 2023
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2031
• Last Updated: October 12, 2023

Record last verified: 2023-10

Locations

CN (1)