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

Recruiting · NCT06754644 · Interventional (participants receive a specific treatment)

Interventions studied

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

Age range

18 Years to 75 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

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;

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;

1 location listed.