Actively Recruiting
SH-1028 Tablets Versus Placebo as Adjuvant Therapy in Resected Stage II-IIIB NSCLC With Sensitizing EGFR Mutations
Led by Nanjing Sanhome Pharmaceutical, Co., Ltd. · Updated on 2023-10-12
242
Participants Needed
1
Research Sites
403 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
SH-1028 Tablets Versus Placebo as Adjuvant Therapy in Resected Stage II-IIIB NSCLC With Sensitizing EGFR Mutations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older but younger than 75 years
- Confirmed diagnosis of primary non-small cell lung cancer with predominantly non-squamous histology
- Brain MRI or CT scan and bone scan done before surgery or randomization to exclude metastases
- Complete tumor removal with negative surgical margins and systematic lymph node removal
- Postoperative pathological stage II, IIIA, or IIIB (only T3N2M0) lung cancer
- Presence of common sensitizing EGFR mutations (Ex19del, L858R), confirmed by central laboratory
- Fully recovered from surgery and any standard postoperative therapy at time of randomization
- ECOG performance status 0-1 with expected survival of at least 12 weeks and no recent decline
- Adequate bone marrow and organ function based on specified laboratory values
- Females of childbearing potential must use contraception and have a negative pregnancy test before dosing
- Male patients must agree to use barrier contraception during and six months after treatment
- Signed written informed consent prior to study admission
You will not qualify if you...
- Presence of unresectable or metastatic lesions, residual lesions after surgery, or limited surgery types (segmentectomy or wedge resection)
- Giant or clustered mediastinal lymph node metastases invading major structures or superior lung sulcus carcinoma
- Prior treatment with any EGFR-TKI, systemic chemotherapy, immunotherapy, targeted therapy, or anti-tumor traditional Chinese medicine except standard platinum-based chemotherapy
- Major surgery within 4 weeks before first study drug dose (except vascular access placement)
- Use of potent CYP3A4 inhibitors or inducers within 1 week before first study drug dose
- Severe or active infections within 2-4 weeks before first dose, including hepatitis B, C, or HIV
- Long-term steroid use or history of immunodeficiency or organ transplantation
- Severe or uncontrolled systemic diseases like hypertension or diabetes
- Significant cardiac abnormalities or risk factors for QT prolongation
- History or evidence of interstitial lung disease or radiation pneumonitis requiring steroids
- History of other cancers within 5 years (except certain skin and cervical cancers)
- Serious gastrointestinal disorders affecting drug absorption
- Known allergy to SH-1028 or similar drugs
- Severe uncontrolled eye diseases
- Participation in another clinical trial within 4 weeks or within 5 half-lives of other study drugs
- Hepatic encephalopathy, hepatorenal syndrome, or moderate to severe liver cirrhosis
- Lactating women
- Any condition deemed unsafe or interfering with study assessments by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
Research Team
K
Kun Cao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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