Clinical Trials Logo
  1. Home
  2. Small Cell Lung Cancer
  3. NCT05354700
  4. Details
NCT05354700 Clinical Trial

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

Small-cell Lung Cancer Clinical Trial

Official title:
An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + Chemotherapy in Patients With Extensive Small Cell Lung Cancer (ES-SCLC)

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05354700
Other study ID # HLX07-SCLC201
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date March 29, 2023
Est. completion date May 29, 2024

Study information
Verified date April 2022
Source Shanghai Henlius Biotech
Contact Xuhui Hu, MD
Phone 18618313742
Email Xuhui_Hu@henlius.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date May 29, 2024
Est. primary completion date March 29, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• HLX07
HLX07 is a recombinant humanized anti-EGFR monoclonal antibody injection, developed by Shanghai Henlius Biotech, Inc.
• HLX10
HLX10 is a recombinant humanized anti-PD-1 monoclonal antibody injection, developed by Shanghai Henlius Biotech, Inc.
• carboplatin and etoposide
chemotherapeutics

Locations
Country Name City State
China Jilin Cancer Hospital Changchun Jilin

Sponsors (1)
Lead Sponsor Collaborator
Shanghai Henlius Biotech

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary ORR Objective response rate by investigator assessment per RECIST 1.1 up to 2 years
Primary PFS Progression-free survival by investigator assessment per RECIST v1.1 Up to 2 years
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04242199 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors Phase 1
Recruiting NCT05552846 - Phase II Trial of Consolidative Thoracic Radiotherapy for ES-SCLC After Standard Care of Chemo-immunotherapy Phase 2
Terminated NCT04022876 - A Study of ALRN-6924 for the Prevention of Chemotherapy-induced Side Effects (Chemoprotection) Phase 1
Recruiting NCT06022757 - Study of XNW5004 Tablet in Combination With KEYTRUDA® (Pembrolizumab) in Subjects With Advanced Solid Tumors Who Failed Standard Treatments (KEYNOTE F19) Phase 1/Phase 2
Recruiting NCT04923776 - Liver Directed RT + Chemo-immunotherapy for ES-SCLC Phase 2
Recruiting NCT04168281 - Watchful Observation of Patients With LD-SCLC Instead of the PCI N/A
Completed NCT03239171 - Bioinformation Therapy for Lung Cancer Phase 2/Phase 3
Recruiting NCT06457906 - SRS/SRT/Hypo-RT Versus HA-WBRT for No More Than 10 Brain Metastases in SCLC Phase 3
Recruiting NCT04539977 - PD-L1 Antibody (TQB2450) Plus Chemotherapy for Previously Untreated Limited- Stage Small-cell Lung Cancer Phase 2
Completed NCT03345485 - Study of the Safety, Pharmacokinetics and Efficacy of EDO-S101, in Patients With Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06103682 - LOcally ABLatIve ThErapy for OligopRogressive Lung And Thoracic MalignanciEs (OBLITERATE) N/A
Recruiting NCT04170946 - Talazoparib and Thoracic RT for ES-SCLC Phase 1
Recruiting NCT03523234 - Neoadjuvant Therapy Combined With Radical Surgery for the Treatment of Small Cell Lung Cancer (SCLC) in II and IIIA Stage N/A
Recruiting NCT05620134 - Study of JK08 in Patients With Unresectable Locally Advanced or Metastatic Cancer Phase 1/Phase 2
Recruiting NCT05578326 - Study of Trilaciclib and Lurbinectidin Phase 2
Recruiting NCT06255197 - Characteristics, Treatment Patterns and Outcomes for Patients With Surgically Resected Lung Cancers
Terminated NCT04610658 - Immune Checkpoint Inhibition With Lurbinectedin Relapsed/Recurrent SCLC Phase 1
Active, not recruiting NCT04116320 - Focused Ultrasound Ablation and PD-1 Antibody Blockade in Advanced Solid Tumors Phase 1
Active, not recruiting NCT05091567 - A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer Phase 3
Terminated NCT04596033 - TiTAN-1: Safety, Proliferation and Persistence of GEN-011 Autologous Cell Therapy Phase 1