Clinical trial · Interventional
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
NCT06754644CI-TRIAL-00090819recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to compare the efficacy similarities between QL2107 and Keytruda in metastatic non-squamous NSCLC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Keytruda® | Drug | Pembrolizumab | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
| QL2107 | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- QL2107
- interventionNames
- Drug: QL2107
- Drug: Pemetrexed
- Drug: Carboplatin
- type
- ACTIVE_COMPARATOR
- label
- Keytruda®
- interventionNames
- Drug: Pemetrexed
- Drug: Carboplatin
- Drug: Keytruda®
Primary outcomes (1)
- measure
- clinical equivalence
- timeFrame
- 24-week
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available
No reference posted for this study.