Health Condition 1: C348- Malignant neoplasm of overlappingsites of bronchus and lung
Conditions
Interventions
Intervention1: Envafolimab Injection: Dosage Form: Injection (200 mg [1.0 mL]/vial)
Dose: 600 mg (3 mL)
Dosage Frequency: once in every three weeks
Mode of Administration: Subcutaneous injection.
Co
Sponsors
Glenmark Specialty SA
Eligibility
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in the study and sign the informed consent form; 2. Age greater than or equal to 18 years old 3. Histological and/or cytological diagnosis of resectable Stage IIIA-IIIB(N2) NSCLC (IASLC Staging Handbook in Thoracic Oncology/American Joint Committee of Cancer[AJCC], 8th Edition). 4. Measurable lesion(s) based on the RECIST Version 1.1 5. ECOG performance status of 0 to 1 6. Sufficient organ and bone marrow function 7. Expected survival greater than or equal to 6 months 8. The subject meets the criteria for radical surgery and the total lung function is able to withstand the proposed pneumonectomy procedure 9. Female subjects of childbearing potential must undergo a serum pregnancy test within 7 days prior to randomization, with a negative result, and male subjects with a partner of childbearing potential must agree to use a reliable and effective method of contraception during the study as per the study protocol.
Exclusion criteria
Exclusion criteria: 1. Tumour is confirmed as or combined with neuroendocrine carcinoma components (large cell carcinoma, small cell carcinoma, neuroendocrine carcinoma, etc.), or sarcomatous/sarcomatoid lesions, or adenosquamous carcinoma, or special pathological types (such as SMARCA4-deficient type, etc.) 2. Previous treatment with another target T cell receptors (e.g., CTLA-4, OX-40, etc.) 3. Subjects with known EGFR sensitive mutation or ALK translocation 4. Upper lung sulcus tumour or locally advanced unresectable or metastatic disease 5. Subjects who have previously received any anticancer treatment for the study disease (including chemotherapy, radiotherapy, immunotherapy, targeted therapy, etc.); or have received alternative traditional medicine (e.g., ayurveda, homeopathy, Chinese medicine) with anticancer indications within 2 weeks prior to randomization 6. Subjects diagnosed with any other malignancy within 5 years prior to randomization, except for cured localized cancers, including cervical carcinoma in situ, basal cell carcinoma, and low-grade prostate cancer, etc. 7. Subjects who have participated in other clinical studies within 4 weeks prior to randomization. 8. Subjects who have undergone major surgery (excluding diagnostic procedures) within 28 days prior to randomization, or who are expected to undergo non-study major surgery during the study 9. Subjects planned to receive cisplatin who have known or suspected hearing impairment, with consecutive hearing measurements greater than 25 dB. 10. Subjects with greater than or equal to Grade 2 peripheral neuropathy 11. Subjects with known or suspected interstitial pneumonia, radiation pneumonitis or other moderate/severe pulmonary diseases that may interfere with the detection or management of drug-related pulmonary toxicity and severely affect respiratory function 12. Any severe active infection, including active tuberculosis, and bacterial, fungal, or viral infections requiring systemic treatment within 14 days prior to randomization; 13. Active hepatitis B virus infection (HBsAg positive and/or HBcAb positive, with HBV-DNA quantification greater than or equal to 2000 IU/mL) or hepatitis C virus infection (HCV antibody positive and HCV-RNA quantification above the lower limit of detection) 14. Subjects with a known history of HIV infection 15. Subjects with uncontrolled or significant cardiovascular and cerebrovascular disease 16. Subjects who have had active autoimmune disease requiring systemic treatment within 2 years prior to randomization 17. Subjects who have used immunosuppressants or systemic hormone therapy for immunosuppressive purposes within 14 days prior to randomization (prednisone, greater than 10 mg/day or other equivalent hormone therapy) 18. Subjects who have received or are planned to receive a live attenuated vaccine within 28 days prior to randomization or during the study. 19. Subjects with a contraindication or history of hypersensitivity to any component of the study drug (including chemotherapy) or any known excipients 20. Pregnant or breastfeeding women 21. Subjects with other conditions that may interfere with participation in the study or are not expected to benefit from participation, or may affect the study results, such as a history of psychiatric disorders, drug addiction or substance abuse, or any other clinically sign
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathologic response (MPR) rate assessed by blinded independent pathology review (BIPR)Timepoint: | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response (pCR) rate assessed by BIPRTimepoint: ;Event Free Survival (FES)Timepoint: ;Disease-free survival (DFS)Timepoint: ;Overall survival (OS)Timepoint: ;Treatment emergent Adverse EventsTimepoint: ;PK and Immunogenicity (Plasma-drug concentration of envafolimab)Timepoint: ;PK and Immunogenicity (ADA and Nab against envafolimab)Timepoint: | — |
Countries
Brazil, India, Mexico, Russian Federation
Contacts
Public ContactAmol Pendse
Glenmark Pharmaceuticals Ltd
Outcome results
None listed