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

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.

Trial Details

NCT ID
NCT06080776
Phase
PHASE3
Sponsor
Nanjing Sanhome Pharmaceutical, Co., Ltd.
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • SH-1028 tablets
  • Placebo SH-1028 tablets
Locations (sample)
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility 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 extra…

For full eligibility, visit ClinicalTrials.gov.

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