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Clinical Trials in China / NCT06754644
Recruiting Phase 3

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

NCT06754644 · tracked via the Priya Life Science China tracker
Sponsor
Qilu Pharmaceutical Co., Ltd.
Phase
Phase 3
Started
2025-01-15
Last updated
2025-06-10

Condition(s) studied

NSCLC

Investigational drug(s) / intervention(s)

QL2107PemetrexedCarboplatinKeytruda®

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)

Trial sites (1)

FacilityCityRegionStatus
Shandong First Medical University Cancer Hospital Jinan Shandong Recruiting

More Qilu Pharmaceutical Co., Ltd. trials in China

Other trials for the same condition

Official registry record

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.

View NCT06754644 on ClinicalTrials.gov ↗ ← All trials in China