Effect of study drug combined with chemotherapy in patients with locally advanced or metastatic lung cancer with mutated receptor responsible for epithelial growth (EGF-R) that progressed after the treatment with other drugs.
- Conditions
- Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous NSCLC Who Have Failed to EGFR-TKI TreatmentMedDRA version: 21.0Level: PTClassification code: 10025125Term: Lung squamous cell carcinoma stage IV Class: 100000004864MedDRA version: 21.0Level: PTClassification code: 10025124Term: Lung squamous cell carcinoma stage III Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-504434-22-00
- Lead Sponsor
- Summit Therapeutics Sub Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 481
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1, Life expectancy = 3 months, Locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-squamous NSCLC confirmed by histology or cytology, inoperable and unable to receive radiotherapy and chemotherapy, The tumor histology, cytology or blood test confirmed the presence of EGFR activating mutations before enrollment, Have previously received EGFR-TKI treatment and the treatment has failed, Subjects have at least one measurable non-brain tumor lesion per RECIST v1.1, Major organ function prior to treatment meets the criteria defined in Protocol, Patients of childbearing potential must agree to use highly effective contraceptive measures
Histological or cytological pathology confirmed the presence of small cell carcinoma components, or the main component is squamous cell carcinoma, Active autoimmune disease requiring systemic treatment within 2 years prior to the start of study treatment, There is a history of major diseases 1 year prior to the first dose, Medical history of gastrointestinal perforation or gastrointestinal fistula within 6 months prior to the first dose, Received chest radiation therapy prior to the first dose, Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage, Active or previously documented inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), There are reports confirming the existence of other driver gene mutations with known drug treatments, Subjects who received any prior treatments targeting the mechanism of tumor immunity, The subject has received systemic anti-tumor therapy other than EGFR-TKI, Currently enrolled in any other clinical study, Received EGFR-TKI treatment, palliative local treatment, non-specific immunomodulatory treatment within 2 weeks prior to the first dose; and Chinese herbal medicine or traditional Chinese medicinal products with anti-tumor indications within 1 weeks prior to the first dose, Tumor surrounds important blood vessels or has obvious necrosis, cavitation, or invades surrounding important organs and blood vessels, Symptomatic central nervous system metastases, Active malignancies within the past 3 years, with the exception of tumors in this study and cured local tumors
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method