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

• Sponsor: Qilu Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05309629
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 30.5
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Extensive-stage Small-cell Lung Cancer	Drug: QL1706; Drug: Carboplatin; Drug: Etoposide	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Apr 18, 2022
• Anticipated Primary Completion Date: Feb 1, 2023
• Anticipated Study Completion Date: Nov 1, 2024

Arms and Interventions

Arm

Intervention/Treatment

Experimental: QL1706+chemotherapy 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; Intravenous infusions of QL1706 5mg/kg on Day 1 of every 21-day cycle.; Drug: 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.; Drug: 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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. Duration of Response (DOR) [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) [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) [Up to approximately 2 years and a half]

   Baseline until death from any cause

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhejiang Cancer Hospital	Hangzhou	Zhejiang	China	310022

Sponsors and Collaborators

• Qilu Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Qilu Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05309629
• Other Study ID Numbers: QL1706-209
• First Posted: Apr 4, 2022
• Last Update Posted: Jul 14, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma; Carboplatin; Etoposide

Study Results

No Results Posted as of Jul 14, 2022