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

• Status: Recruiting
• Trial end date: 2022-05-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jie Li
• Collaborators: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences; Ministry of Science and Technology of the People´s Republic of China

Criteria

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.