QL2107: 200mg on day 1 of each 21-day cycle of the study
Pemetrexed: 500 mg/m2 on Day 1 of each 21-day cycle of the study
Carboplatin: Target AUC of 5 mg/mL/min on Day 1 of each 21-day cycle up to 4 cycles
Keytruda®: 200mg on day 1 of each 21-day cycle of the study
Study summary
The goal of this clinical trial is to compare the efficacy similarities between QL2107 and Keytruda in metastatic non-squamous NSCLC.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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;
Primary outcome measure(s)
clinical equivalence — 24-week The 24-week objective response rate (24-week ORR, defined as the proportion of subjects who achieve CR or PR based on best efficacy at any time within 24 weeks after administration, evaluated according to RECIST 1.1) assessed by the Independent Review Committee (IRC)
Trial sites (1)
Facility
City
Region
Status
Shandong First Medical University Cancer Hospital
Jinan
Shandong
Recruiting
More Qilu Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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