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NCT Number: NCT05309629

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

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.

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Key information

Conditions

Extensive-stage Small-cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects participate voluntarily and sign informed consent.
  • Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system)
  • No prior systemic treatment for ES-SCLC
  • Eastern Cooperative Oncology Group performance status of 0 or 1
  • Measurable disease, as defined by RECIST v1.1
  • Adequate hematologic and end organ function

Exclusion criteria

  • Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation
  • Active, known or suspected autoimmune disease
  • 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.
  • Positive test result for human immunodeficiency virus (HIV)
  • Active hepatitis B or hepatitis C
  • Significant cardiovascular disease

Treatment and study plan

QL1706

Drug

Intravenous infusions of QL1706 5mg/kg on Day 1 of every 21-day cycle.

carboplatin

Drug

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

Drug

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.

Primary outcomes

  1. Number of Participants Who Experienced At Least One Adverse Event (AE)

    Time frame: 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 outcomes

  1. Percentage of Participants With Objective Response (OR)

    Time frame: Up to approximately 2 years

    The efficacy outcome of objective response rate (ORR) as assessed by the investigator using RECIST v1.1

  2. Duration of Response (DOR)

    Time frame: Up to approximately 2 years

    The efficacy outcome of DOR as assessed by the investigator using RECIST v1.1

  3. Duration of Progression-Free Survival (PFS)

    Time frame: Up to approximately 2 years

    The efficacy outcome of PFS as assessed by the investigator using RECIST v1.1

  4. Duration of Overall Survival (OS)

    Time frame: Up to approximately 2 years and a half

    Baseline until death from any cause

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Apr 4, 2022
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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