NCT06754644RecruitingPhase 3
A Study to Evaluate Efficacy, and Safety of QL2107 Plus Chemo and Compare With Keytruda in Participants With IV nqNSCLC
A Randomized, Double-blind, Multicenter Phase III Clinical Study to Compare the Efficacy and Safety of QL2107 Versus Keytruda® in Combination With Chemotherapy in the Treatment of Metastatic Non-squamous Non-small-cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 10 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this clinical trial is to compare the efficacy similarities between QL2107 and Keytruda in metastatic non-squamous NSCLC.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 808 (estimated)
- First submitted
- 23 Dec 2024
- Start date
- 15 Jan 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT06754644
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 808
- From 15 Jan 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other
- 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;
Who the study is looking for
- 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;
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shandong First Medical University Cancer Hospital Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.