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

NCT05309629 | Completed Phase 2

• 1 other identifier: QL1706-209
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Extensive-stage Small-cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Percentage of Participants With Objective Response (OR)

  Up to approximately 2 years

• Duration of Response (DOR)

  Up to approximately 2 years

• Duration of Progression-Free Survival (PFS)

  Up to approximately 2 years

• Duration of Overall Survival (OS)

  Up to approximately 2 years and a half

Study Arms (1)

QL1706+chemotherapy

EXPERIMENTAL

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.

Drug: QL1706; Drug: Carboplatin; Drug: Etoposide

Interventions

QL1706 DRUG

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

QL1706+chemotherapy

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.

QL1706+chemotherapy

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.

QL1706+chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Carboplatin; Etoposide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 4, 2022
• Study Start: April 18, 2022
• Primary Completion: February 1, 2023
• Study Completion: December 13, 2024
• Last Updated: January 17, 2025

Record last verified: 2022-11

Locations

CN (1)