A Phase 3 interventional study of QL2107 and Pemetrexed in NSCLC, sponsored by Qilu Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-06-10.
Sponsored by Qilu Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment
The goal of this clinical trial is to compare the efficacy similarities between QL2107 and Keytruda in metastatic non-squamous NSCLC.
Qilu Pharmaceutical Co., Ltd. is the lead sponsor of 193 studies on the registry; 119 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: QL2107 · Drug: Pemetrexed · Drug: Carboplatin
Drug: Pemetrexed · Drug: Carboplatin · Drug: Keytruda®
200mg on day 1 of each 21-day cycle of the study
500 mg/m2 on Day 1 of each 21-day cycle of the study
Target AUC of 5 mg/mL/min on Day 1 of each 21-day cycle up to 4 cycles
200mg on day 1 of each 21-day cycle of the study
clinical equivalence
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)
Time frame: 24-week
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Qilu Pharmaceutical Co., Ltd.