Clinical trial · Interventional
Safety and Efficacy Study of First-line Treatment With QL1706 Plus Chemotherapy in Extensive-Stage Small Cell Lung Cancer
An Open-label Phase 2 Study of QL1706 Plus Carboplatin and Etoposide as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer
NCT05309629CI-TRIAL-00084856completedPhase 2ClinicalTrials.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)
This is an open label, phase 2 clinical study to evaluate the safety, tolerability, efficacy, pharmacokinetic (PK) profile, and immunogenicity of QL1706 plus carboplatin and etoposide as first-line therapy in patients with extensive-stage small cell lung cancer.
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 |
|---|---|---|---|
| Extensive-stage Small-cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| QL1706 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- QL1706+chemotherapy
- description
- Participants received intravenous infusions of QL1706 5mg/kg in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle for 4-6 cycles. On Days 2 and 3 of every 21-day cycle, etoposide 100 mg/m\^2 was administered alone for 4-6 cycles. Thereafter, participants received maintenance QL1706 5mg/kg on Day 1 of every 21-day cycle until progressive disease, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
- interventionNames
- Drug: QL1706
- Drug: Carboplatin
- Drug: Etoposide
Primary outcomes (1)
- measure
- Number of Participants Who Experienced At Least One Adverse Event (AE)
- timeFrame
- Up to approximately 2 years
- description
- An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The number of all participants who experienced at least one AE is presented.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects participate voluntarily and sign informed consent. 2. Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \[VALG\] staging system) 3. No prior systemic treatment for ES-SCLC 4. Eastern Cooperative Oncology Group performance status of 0 or 1 5. Measurable disease, as defined by RECIST v1.1 6. Adequate hematologic and end organ function Exclusion Criteria: 1. Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation 2. Active, known or suspected autoimmune disease 3. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, radiation pneumonia requiring steroid treatment or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted. 4. Positive test result for human immunodeficiency virus (HIV) 5. Active hepatitis B or hepatitis C 6. Significant cardiovascular disease
References
Publications (0)
Data not yet available
No reference posted for this study.