A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX17 Vs. Keytruda® in the First-Line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer

This study includes three treatment groups. Patients will be randomly assigned at a 2:1:1 ratio to the HLX17, US-sourced Keytruda® and EU-sourced Keytruda® group to receive the treatment of IMPs in combination with Carboplatin Plus Pemetrexed until disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent form, death, unacceptable toxicity, or up to 17 cycles (whichever occurs first).

Age

18–75

Sex

ALL

Healthy volunteers

Not accepted

You may be eligible if

Histologically or cytologically confirmed diagnosis of stage IV inoperable to surgery or radiotherapy (AJCC 8th edition) non-squamous NSCLC.
Without any tumor activating EGFR mutation or ALK or ROS1 gene rearrangement.
Have not received prior systemic treatment for their advanced/metastatic NSCLC.
At least one measurable lesion as assessed by IRRC based on RECIST v1.1.
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
Have adequate organ function.

You may not be if

Subjects with NSCLC of other histopathological types, such as mixed adenosquamous carcinoma, and subjects with small cell lung cancer or neuroendocrine carcinoma.
Subjects with other active malignancies within 5 years or at the same time prior to screening.
Active central nervous system metastases.
Known interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, and severe lung function abnormalities that may impede the investigators' diagnosis and management of drug-related pulmonary toxicity.
Known active or suspected autoimmune diseases.
History of immunodeficiency, including HIV antibody positive, active hepatitis B; or hepatitis C virus infections.
Have received pembrolizumab or any other immune checkpoints inhibitors (PD-1, PD-L1, CTLA4, etc.) before screening.
Pregnant or breastfeeding female.
The investigator has a clear reason to believe that participation in this study would be detrimental to the subject.

What this study is about