A Study of SYS6010 Combined With Osimertinib Versus Osimertinib Alone as Neoadjuvant Therapy for Patients With EGFR Mutation-positive Resectable Non-squamous Non-small Cell Lung Cancer

Официальное название

A Phase II Study to Evaluate the Safety and Efficacy of SYS6010 Combined With Osimertinib Versus Osimertinib as Neoadjuvant Therapy in Participants With Resectable Stage II-IIIB Non-squamous Non-small Cell Lung Cancer With EGFR Mutation Positive

Обзор

To evaluate the safety and efficacy of SYS6010 combined with osimertinib as neoadjuvant therapy for patients with resectable EGFR mutation non-squamous non-small cell lung cancer.

Подробное описание

This study includes three stages: a neoadjuvant therapy stage, a surgery stage, and an adjuvant follow-up stage. In the neoadjuvant therapy stage, eligible participants will be stratified by stage (Stage II and Stage III) and mutation type (19Del and L858R) and randomized in a 1:1 ratio to the SYS6010 combined with osimertinib treatment group and the osimertinib monotherapy group. Neoadjuvant therapy will be administered for 3 cycles.

In the surgery stage, the feasibility of surgery will be assessed by a thoracic surgery investigator. Surgery should be performed between Week 10 and Week 12 (i.e., D64-D84 after the first dose of neoadjuvant therapy). Tumor samples collected during surgery will be sent to a central pathology laboratory to assess pathological response.

In the adjuvant therapy stage, all participants who undergo surgery will subsequently enter the adjuvant therapy stage. Participants who do not undergo surgery for reasons other than disease progression will also enter the adjuvant therapy stage.

Вмешательства

• Препарат SYS6010
  SYS6010 by intravenous (IV) infusion
• Препарат Osimertinib
  Osimertinib, oral
• Препарат Pemetrexed
  500 mg/m\^2 by IV infusion, Q3W
• Препарат Cisplatin
  75 mg/m\^2 by IV infusion, Q3W
• Препарат Carboplatin
  AUC 5 mg/mL•min by IV infusion, Q3W

Первичные конечные точки

• Major Pathological Response (MPR) Rate [Срок оценки: Within 8 weeks post-surgery]
• Pathological Complete Response (pCR) Rate [Срок оценки: Within 8 weeks post-surgery]
• Downstaging from N2 to N0/N1 or N1 to N0 at the time of surgery [Срок оценки: Within 8 weeks post-surgery]
• Disease-Free Survival (DFS) [Срок оценки: Up to approximately 5.5 years after the last participant enrolled]
• Event-Free Survival (EFS) [Срок оценки: Up to approximately 5.5 years after the last participant enrolled]
• Objective Response Rate (ORR) [Срок оценки: Up to approximately 5.5 years after the last participant enrolled]
• Overall Survival (OS) [Срок оценки: Up to approximately 5.5 years after the last participant enrolled]
• Incidence of Adverse Events (AEs) [Срок оценки: Up to approximately 5.5 years after the last participant enrolled]
• Anti-drug Antibodies (ADAs) to SYS6010 [Срок оценки: Up to approximately 5.5 years after the last participant enrolled]

Критерии участия

Критерии включения

• Able to understand and voluntarily sign the written informed consent form (ICF);
• Age 18-75 years, regardless of sex;
• Histologically or cytologically confirmed non-squamous non-small cell lung cancer, staged as resectable or potentially resectable Stage II-IIIB disease according to the International Association for the Study of Lung Cancer (IASLC) 8th Edition TNM staging criteria;
• Must be eligible for complete surgical resection of the primary tumor;
• Nodal status must be evaluated by whole-body FDG-PET and contrast-enhanced CT;
• Confirmed presence of an EGFR-sensitizing mutation (exon 19 deletion or exon 21 L858R mutation, co-mutation with other EGFR sites is allowed), as tested by a central laboratory or local testing facility;
• No prior systemic anti-tumor therapy (including chemotherapy, biotherapy, targeted therapy, immunotherapy);
• At least one measurable lesion at baseline as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
• Life expectancy ≥6 months;
• Adequate major organ and bone marrow function;
• Women or men of childbearing potential must use highly effective contraception.

1\. Able to understand and voluntarily sign the written informed consent form (ICF); 2. Age 18-75 years, regardless of sex; 3. Histologically or cytologically confirmed non-squamous non-small cell lung cancer, staged as resectable or potentially resectable Stage II-IIIB disease according to the International Association for the Study of Lung Cancer (IASLC) 8th Edition TNM staging criteria; 4. Must be eligible for complete surgical resection of the primary tumor; 5. Nodal status must be evaluated by whole-body FDG-PET and contrast-enhanced CT; 6. Confirmed presence of an EGFR-sensitizing mutation (exon 19 deletion or exon 21 L858R mutation, co-mutation with other EGFR sites is allowed), as tested by a central laboratory or local testing facility; 7. No prior systemic anti-tumor therapy (including chemotherapy, biotherapy, targeted therapy, immunotherapy); 8. At least one measurable lesion at baseline as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; 9. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; 10. Life expectancy ≥6 months; 11. Adequate major organ and bone marrow function; 12. Women or men of childbearing potential must use highly effective contraception.

Критерии исключения

• Diagnosis of Stage I, Stage IIIB with N3, and Stage IIIC, IVA, and IVB non-small cell lung cancer;
• Multiple primary malignancies (refer to exclusion criterion #8 for synchronous primary lung cancer) OR a mixed histology of SCLC and NSCLC;
• T4 stage lung cancer due to invasion of the great vessels, carina, trachea, esophagus, heart, or vertebral body; and/or bulky N2 disease;
• Eligible only for segmentectomy or wedge resection;
• Receipt of Chinese patent medicine preparations indicated for the treatment of lung cancer within 1 week before randomization;
• Major surgery or severe traumatic injury within 4 weeks before the first study treatment, or expected to undergo major surgery during the study period;
• History of other primary malignant tumor (including any known or suspected concurrent primary lung cancer);
• History of autoimmune disease, immunodeficiency, or organ transplant (except for corneal transplant);
• Refractory nausea, vomiting, chronic gastrointestinal disease, inability to swallow drugs orally;
• Evidence of severe or uncontrolled medical conditions (including uncontrolled hypertension, diabetes mellitus, etc,);
• Active or prior history of interstitial lung disease (ILD)/pneumonitis;
• Expected to receive live vaccine therapy within 30 days after randomization;
• History of a definite neurological or mental disorder; known allergy, hypersensitivity, or intolerance to the study drugs or any of their excipients;
• Pregnant or lactating women;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07256509 · SYS6010-013

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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