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