Evaluation of the Efficacy and Safety of AL2846 Capsule Combined With TQB2450 Injection Compared to Docetaxel Injection in Advanced Non-small Cell Lung Cancer Patients Who Have Failed With Immunotherapy.
Non-small Cell Lung Cancer
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria: Age: 18-75 years; Eastern Eastern Cooperative Oncology Group performance status (ECOG PS) score: 0-1; BMI ≥ 17 at baseline; Patients with histologically or cytologically confirmed inoperable and inoperable locally advanced (stage IIIB/IIIC), metastatic or recurrent (stage IV) nonsmall-cell lung cancer (NSCLC) who cannot receive radical concurrent chemoradiotherapy; Failure of platinum-based chemotherapy and immune checkpoint inhibitors for incurable locally advanced or metastatic or recurrent NSCLC; Number of lines of prior systemic therapy received for locally advanced or metastatic/recurrent disease that is unresectable/not amenable to radical chemoradiation; Adequate major organ function; Exclusion Criteria: Patients who had or currently had other malignant tumors within 3 years; Presence of:epidermal growth factor receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) fusion, c-ros oncogene 1 (ROS1) fusion and other significant driver gene mutations; Factors affecting oral drugs; Major surgical treatment, incisional biopsy or obvious traumatic injury and long-term uncured wound or fracture within 28 days before the start of study treatment; Hyperactive/venous thrombotic events within 6 months; Subjects with any severe and/or uncontrolled disease; Previously received other immunotherapy and Research Advance of Small Molecular Targeted Anti-Tumor Agents Tyrosine kinase inhibitors (TKIs); According to the investigator's judgment, there are concomitant diseases that seriously endanger the subject's safety or affect the completion of the study, or there are other reasons that are not suitable for the subject;
Sites / Locations
- Peking University First HospitalRecruiting
- Chinese PLA General HospitalRecruiting
- TianJin Medical University Cancer Institute & HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
TQB2450 injection + docetaxel injection matching placebo + AL2846 capsules
TQB2450 matching placebo + docetaxel injection + AL2846 matching placebo
TQB2450 injection combined with docetaxel injection matching placebo and AL2846 capsules 21 days as a treatment cycle.
TQB2450 matching placebo combined with docetaxel injection and AL2846 matching placebo 21 days as a treatment cycle.