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Home Qilu Pharmaceutical Launches Phase III Clinical Trial of QL2107, a Pembrolizumab Biosimilar, in First-Line Metastatic Non-Squamous NSCLC

Qilu Pharmaceutical Launches Phase III Clinical Trial of QL2107, a Pembrolizumab Biosimilar, in First-Line Metastatic Non-Squamous NSCLC

May 31, 2025 11:01 CST Updated 11:01
Qilu Pharmaceutical

Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

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Qilu Pharmaceutical Co., Ltd. is conducting a "Randomized, Double-blind, Multicenter Phase III Clinical Study Comparing the Efficacy and Safety of QL2107 or Pembrolizumab Originator Combined with Chemotherapy in the Treatment of Metastatic Non-squamous Non-small Cell Lung Cancer." This study is being conducted in multiple hospitals across China and plans to recruit 808 first-line non-squamous non-small cell lung cancer patients.


QL2107 Injection is a pembrolizumab biosimilar developed by Qilu Pharmaceutical. This PD-1 inhibitor blocks the interaction between PD-1 and PD-L1, PD-L2, synergistically activating T-cell immune function and expanding T-cells, thereby enhancing the body's anti-tumor immunity to achieve the therapeutic goal of fighting tumors.

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Main Inclusion Criteria



  • Age ≥18 years and ≤75 years on the day of signing the informed consent form;

  • Patients with metastatic (Stage IV) non-squamous non-small cell lung cancer confirmed by histology or cytology (American Joint Committee on Cancer [AJCC] 8th Edition);

  • Able to provide fresh or archived tissue samples for PD-L1 testing in a central laboratory;

  • No EGFR mutation/ROS1 rearrangement/ALK rearrangement. For those with other targeted mutations such as BRAF V600E mutation/NTRK1/2/3 gene fusion/MET exon 14 skipping mutation/RET rearrangement positivity, etc., if the corresponding targeted therapy drugs have been approved, they are not allowed to be included in this study.




Benefits of Participating in the Study



1. Free study treatment drugs: QL2107 Injection/Pembrolizumab Injection, Carboplatin, Pemetrexed Disodium;

2. Free tests related to the trial, including: blood routine, blood biochemistry, urine routine, echocardiogram, CT/MRI imaging examinations, etc.;

3. Appropriate transportation subsidies, blood-drawing nutrition subsidies, and biopsy subsidies, etc.


Patients who are interested in participating in the study can visit or call the participating hospitals nearby for consultation.


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Source: Qilu Pharmaceutical Group Official Account | Initial Review: Wang Yao

Re-review: Teng Chunyan │ Final Review: Liu Bin

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