A Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy in Patients With Extensive Small Cell Lung Cancer

NCT ID: NCT05354700

Last Updated: 2022-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-29

Study Completion Date

2024-05-29

Brief Summary

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This study is conducted in patients with advanced metastatic small cell lung cancer (SCLC). This study includes a single arm: the patients will receive HLX07 combination therapy with HLX10 and chemotherapy (carboplatin+etoposide) as first-line treatment. All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, HLX10 treatment up to 2 years).

Detailed Description

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Conditions

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Small-cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HLX07+HLX10+Chemotherapy

HLX07+HLX 10+Chemotherapy (Carboplatin-Etoposide)

Group Type EXPERIMENTAL

HLX07

Intervention Type DRUG

HLX07 is a recombinant humanized anti-EGFR monoclonal antibody injection, developed by Shanghai Henlius Biotech, Inc.

HLX10

Intervention Type DRUG

HLX10 is a recombinant humanized anti-PD-1 monoclonal antibody injection, developed by Shanghai Henlius Biotech, Inc.

carboplatin and etoposide

Intervention Type DRUG

chemotherapeutics

Interventions

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HLX07

HLX07 is a recombinant humanized anti-EGFR monoclonal antibody injection, developed by Shanghai Henlius Biotech, Inc.

Intervention Type DRUG

HLX10

HLX10 is a recombinant humanized anti-PD-1 monoclonal antibody injection, developed by Shanghai Henlius Biotech, Inc.

Intervention Type DRUG

carboplatin and etoposide

chemotherapeutics

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system)
* No prior systemic therapy for ES-SCLC
* Major organs are functioning well
* Participant must keep contraception

Exclusion Criteria

* Histologically or cytologically confirmed mixed SCLC
* Known history of severe allergy to any monoclonal antibody
* Known hypersensitivity to carboplatin or etoposide
* Pregnant or breastfeeding females
* Patients with a known history of psychotropic drug abuse or drug addiction
* Patients who have other factors that could lead to the early termination of this study based on the investigator's judgment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Henlius Biotech

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Jilin Cancer Hospital

Changchun, Jilin, China

Site Status

Countries

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China

Central Contacts

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Xuhui Hu, MD

Role: CONTACT

18618313742

Facility Contacts

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Ying Cheng, MD

Role: primary

0431-85872600

Other Identifiers

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HLX07-SCLC201

Identifier Type: -

Identifier Source: org_study_id

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