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

Recruiting Phase 3 Interventional Study
Non-small Cell Lung Cancer
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
242 (estimated)
Sponsor
Nanjing Sanhome Pharmaceutical, Co., Ltd. · Industry
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About This Trial

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 Locations
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Eligibility Criteria
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 ex…
Contacts

Kun Cao

86-15776680370

caokun@sanhome.com

CONTACT