Safety and Efficacy Study of First-line Treatment With QL1706 Plus Chemotherapy in Extensive-Stage Small Cell Lung Cancer

Phase 2

Completed

• Conditions: Extensive-stage Small-cell Lung Cancer
• Interventions: Drug: QL1706; Drug: Carboplatin; Drug: Etoposide

• Registration Number: NCT05309629
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-25
• Study First Submitted QC: 2022-03-25
• Study First Posted: 2022-04-04
• Study Start: 2022-04-18
• Status Verified: 2022-11
• Primary Completion: 2023-02-01
• Study Completion: 2024-12-13
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
QL1706+chemotherapy	QL1706	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.
QL1706+chemotherapy	Etoposide	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.
QL1706+chemotherapy	Carboplatin	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced At Least One Adverse Event (AE)	Up to approximately 2 years	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.

Secondary Outcome Measures

Name	Time	Method
Duration of Overall Survival (OS)	Up to approximately 2 years and a half	Baseline until death from any cause
Percentage of Participants With Objective Response (OR)	Up to approximately 2 years	The efficacy outcome of objective response rate (ORR) as assessed by the investigator using RECIST v1.1
Duration of Progression-Free Survival (PFS)	Up to approximately 2 years	The efficacy outcome of PFS as assessed by the investigator using RECIST v1.1
Duration of Response (DOR)	Up to approximately 2 years	The efficacy outcome of DOR as assessed by the investigator using RECIST v1.1

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China