A Study to Evaluate Efficacy, and Safety of QL2107 Plus Chemo and Compare With Keytruda in Participants With IV nqNSCLC

A Randomized, Double-blind, Multicenter Phase III Clinical Study to Compare the Efficacy and Safety of QL2107 Versus Keytruda® in Combination With Chemotherapy in the Treatment of Metastatic Non-squamous Non-small-cell Lung Cancer

The goal of this clinical trial is to compare the efficacy similarities between QL2107 and Keytruda in metastatic non-squamous NSCLC.

Inclusion Criteria:

• Subjects who voluntarily participate, sign the Informed Consent Form (ICF), and are able to comply with the study procedures;
• Subjects aged ≥ 18 and ≤ 75 years at enrollment, male or female;
• Histologically or cytologically confirmed metastatic (stage IV) non-squamous NSCLC as per the American Joint Committee on Cancer (AJCC) 8th Edition; if multiple tumor histologies are present, the predominant cell type should be classified;
• No EGFR sensitive mutations or ALK gene translocations.
• Expected survival ≥ 3 months;
• Eastern Cooperative Oncology Group (ECOG) performance status score: 0 or 1;

Exclusion Criteria:

• Pulmonary radiation therapy > 30 Gy within 6 months prior to the first dose;
• Palliative radiation therapy completed within 7 days prior to the first dose;
• Any other form of anti-tumor therapy expected to be required during the study;
• Uncontrolled or symptomatic pericardial effusion, pleural effusion and ascites requiring repeated paracentesis and drainage;
• Presence of metastases to brain stem, meninges and spinal cord or compression;