Clinical Trial of Kanglaite Injection (KLTi) in Advanced Non-Small Cell Lung Cancer (NSCLC)

Clinical Trial on the Survival Advantage of Kanglaite Injection (KLTi) in Advanced Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to evaluate the efficacy and safety of Kanglaite Injection for advanced non-small cell lung cancer(NSCLC).

This study include a multicenter, randomized, controlled post-market clinical trial.The randomized clinical trial will enroll approximately 334 patients. Participants will be randomly divided into experimental (n=167) and control groups (n=167).Patients in the experimental group will receive Kanglaite Injection combination with first-line chemotherapy based on NCCN Guidelines (2019.V3). Patients in the control group will receive first-line chemotherapy based on NCCN Guidelines (2019.V3).The primary endpoint is PFS(progression free survival).The research protocol was approved by the relevant ethics committees, and the study was conducted according to the Declaration of Helsinki and Good Clinical Practice guidelines. Patients gave written informed consent to participate in the trial.

Inclusion Criteria:

• A Histological or cytological confirmed diagnosis of Stage III-IV NSCLC, with no history of anticancer treatment including chemotherapy;
• Male or female aged 18-75years;
• Eastern Cooperative Oncology Group (ECOG) performance score 0-2;
• Life expectancy of at least 3 months;
• At least one radiographically measurable lesion per RECIST 1.1;
• Willing to join the clinic trail and sign informed consent;
• Able to comply with scheduled visits and treatments.

Exclusion Criteria:

• Presence of cerebral metastases;
• Confirmed positive for expression of expression of epidermal growth factor receptor (EGFR), activin receptor-like kinase (ALK), c-ros oncogene 1 (ROS1) mutation, or programmed death-ligand 1 (PD-L1)(tumor proportion score [TPS≥ 50%] in a genetic test;
• Participants with malignant pleural effusion underwent intrapleural injection chemotherapy;
• Current undergoing or preparing for treatment with target therapy;
• Current undergoing or preparing for radiotherapy to the thorax;
• Current undergoing or preparing treatment with tumor immunotherapy;
• Currently undergoing lipid-decreasing treament;
• Pregnant or breastfeeding woman;
• Fertile patients who are unwilling or unable to take effective contraceptive measures during the research period until 6 months after the study end later;
• A history of mental disorders；
• Severe and uncontrolled organic lesion or infection, including but not limited to cardiopulmonary failure and renal failure，which lead to poor tolerance of chemotherapy;
• Participated in other clinical trials of small molecule research drugs within 28 days prior to enrollment, or participated in other clinical trials of large molecule research drugs within 3 months before enrollment;
• Known allergy or intolerance to study medications;
• Considered to be otherwise unsuitable for the clinical study by researchers.