A Study to Evaluate Efficacy, and Safety of QL2107 Plus Chemo and Compare With Keytruda in Participants With IV nqNSCLC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QL2107, Pemetrexed, Carboplatin, Keytruda®.
- Who it may be relevant to
- Registry conditions: NSCLC. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
The goal of this clinical trial is to compare the efficacy similarities between QL2107 and Keytruda in metastatic non-squamous NSCLC.
Interventions
- Drug QL2107
200mg on day 1 of each 21-day cycle of the study - Drug Pemetrexed
500 mg/m2 on Day 1 of each 21-day cycle of the study - Drug Carboplatin
Target AUC of 5 mg/mL/min on Day 1 of each 21-day cycle up to 4 cycles - Drug Keytruda®
200mg on day 1 of each 21-day cycle of the study
Primary outcome measures
- clinical equivalence [Time frame: 24-week]
Eligibility criteria
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shandong First Medical University Cancer Hospital — Jinan
Identifiers
NCT: NCT06754644 · QL2107-301-CN