Phase
Condition
Cancer
Lung Cancer
Non-small Cell Lung Cancer
Treatment
QL1706
Tilesizumab
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Be≥18 to ≤ 75 years of age at enrollment, male or female.
Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) thatnot amenable to complete surgical resection and not amenable to radicalconcurrent/sequential chemoradiation or metastatic (Stage IV) NSCLC (American JointCommittee on Cancer [AJCC] 8th edition).
No EGFR sensitive mutations or ALK gene translocation alterations.
Capable of providing fresh or archived 2 years' tissue samples collected atpost-diagnosis or non-radiation sites at diagnosis for central laboratory PD-L1testing with TPS < 1% .
Have a life expectancy of at least 3 months.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
No prior systemic therapy for advanced or metastatic NSCLC was received.
Exclusion
Exclusion Criteria:
Previous treatment with immune checkpoint inhibitors (PD-1/PD-L1 drugs or drugsacting on another T cell receptor (e.g., CTLA-4 etc.), as well as immune checkpointagonistic antibodies (e.g., anti ICOS , CD40 , CD137 , GITR , OX40 antibodies,etc.), and immune cell therapy.
Patients who have received systemic corticosteroids or other immunosuppressive drugswithin 2 weeks prior to the first dose.
Presence or history of any active autoimmune disease, including, but not limited to:autoimmune hepatitis, interstitial pneumonia, pulmonary fibrosis, uveitis,enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism,hypothyroidism.
Pulmonary radiation therapy > 30 Gy within 6 months prior to first dose;
Palliative radiotherapy completed 7 days prior to first dose.
Known or symptomatic active central nervous system (CNS) metastases or carcinomatousmeningitis during screening.
Clinically significant cardiovascular or cerebrovascular disease
Study Design
Study Description
Connect with a study center
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
ChinaSite Not Available
Sun Yat-sen University Cancer Center
Guangzhou 1809858, Guangdong 1809935
ChinaSite Not Available

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