A Study of QL1706 Combined With Platinum-containing Chemotherapy in Adjuvant Treatment of Stage II-IIIB Non-small Cell Lung Cancer After Complete Surgical Resection.

Korábbi kezelés

• Currently participating in and receiving study treatment or participating in an investigational drug study and receiving study treatment or using an investigational device within 4 weeks prior to the first dose of study treatment.
• Previous treatment with neoadjuvant/adjuvant chemotherapy or immune checkpoint inhibitor therapy.
• Administer a live vaccine within 30 days prior to the first dose of study treatment.
• Other malignancies occurred within 5 years prior to study enrollment. (Except: Bowen's disease; cured basal cell or squamous cell skin cancer; prostate cancer with a Gleason score of 6; treated cervical carcinoma in situ.)
• Previously allergic to macromolecular protein preparations, or to any component of QL1706 and other investigational drugs; history of severe allergy to chemotherapy drugs (pemetrexed, vinorelbine, paclitaxel, cisplatin, carboplatin) or their preventive drugs, etc.
• History of psychotropic substance abuse, alcohol or drug abuse; prior history of clear neurological or psychiatric disorders, including epilepsy or dementia.

Más betegség

• Cardiovascular and cerebrovascular diseases with clinical significance.
• Gastrointestinal disease of clinical significance.
• Human immunodeficiency virus (HIV) antibody positive; Treponema pallidum antibody positive.
• Active uncontrolled hepatitis B or active hepatitis C.

Egyéb

• Clinically significant lung damage.

• Subjects voluntarily participated, signed an informed consent form (ICF), and were able to follow the study procedures.
• Histopathologically confirmed squamous or non-squamous non-small cell lung cancer
• Stage II-IIIB according to the 8th edition of the American Joint Committee on Cancer (AJCC) , and had received radical surgical resection (R0) treatment.
• Participants were enrolled to receive adjuvant therapy within 10 weeks after surgery (≤70 days) and had to recover sufficiently from surgery.
• Non-squamous NSCLC subjects without EGFR-sensitizing mutation or ALK fusion gene.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Subjects (including women and men) agreed to use effective contraception from the time of signing the informed consent to 180 days after the last use of the study drug.