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

Qilu Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Extensive-stage Small-cell Lung Cancer

Treatments: Drug: Etoposide; Drug: QL1706; Drug: Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05309629

QL1706-209

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

QL1706+chemotherapy

Experimental group

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.

Treatment:

Drug: Carboplatin

Drug: QL1706

Drug: Etoposide