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

Extensive-stage Small-cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05309629
• Other study ID #: QL1706-209
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 18, 2022
• Est. completion date: November 1, 2024

Study information

• Verified date: November 2022
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: November 1, 2024
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Extensive-stage Small-cell Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• QL1706
Intravenous infusions of QL1706 5mg/kg on Day 1 of every 21-day cycle.
• Carboplatin
Carboplatin intravenous infusion to achieve an initial target AUC of 5 mg/mL/min was administered on Day 1 of each 21-day cycle for 4-6 cycles.
• Etoposide
Etoposide intravenous infusion was administered at a dose of 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for 4-6 cycles.

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Experienced At Least One Adverse Event (AE)	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.	Up to approximately 2 years
Secondary	Percentage of Participants With Objective Response (OR)	The efficacy outcome of objective response rate (ORR) as assessed by the investigator using RECIST v1.1	Up to approximately 2 years
Secondary	Duration of Response (DOR)	The efficacy outcome of DOR as assessed by the investigator using RECIST v1.1	Up to approximately 2 years
Secondary	Duration of Progression-Free Survival (PFS)	The efficacy outcome of PFS as assessed by the investigator using RECIST v1.1	Up to approximately 2 years
Secondary	Duration of Overall Survival (OS)	Baseline until death from any cause	Up to approximately 2 years and a half