Real-world First-line Serplulimab-based Immunochemotherapy for Extensive-stage Small Cell Lung Cancer

NCT06748495 | Active Not Recruiting

• 1 other identifier: ASTRUM-005R
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

The phase III ASTRUM-005 study (NCT04063163) has demonstrated promising antitumor efficacy and well tolerability of first-line serplulimab combined with chemotherapy in patients with extensive-stage small cell lung cancer (ES-SCLC). However, due to the strict eligibility criteria of randomized controlled trials (RCTs), real-world data on patients with more complex and varied conditions are currently lacking. This highlights the urgent need for real-world evidence to better understand the practical effectiveness and safety of treatments. ASTRUM-005R is a multicenter real-world study conducted in China, designed to evaluate the efficacy and safety of the first-line treatment serplulimab-based immunochemotherapy for ES-SCLC in real-world clinical practice. Additionally, it aims to compare its findings with the data of the randomized controlled phase III ASTRUM-005 trial (descriptive), providing insights into optimal treatment strategies for this patient population.

Conditions

Extensive-stage Small Cell Lung Cancer (ES-SCLC)

Keywords

Real Word

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  defined as the time from the start of chemotherapy to the first occurrence of disease progression or death due to any cause, assessed by the physician according to RECIST 1.1, with the response assessment record as the determination standard

  1yaer

Secondary Outcomes (3)

• Overall survival (OS)

  1yaer

• Objective response rate (ORR)

  1yaer

• AEs

  1yaer

Study Arms (1)

Serplulimab

the combination of Serplulimab and chemotherapy regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Histologically/cytologically confirmed small cell lung cancer with staging that confirming disease stage as extensive (according to the modified American Veterans Administration Lung Cancer Society \[VALG\] staging system). No prior systemic therapy for the diagnosis of ES-SCLC.

You may qualify if:

• Histologically/cytologically confirmed small cell lung cancer with staging that confirming disease stage as extensive (according to the modified American Veterans Administration Lung Cancer Society \[VALG\] staging system);
• No prior systemic therapy for the diagnosis of ES-SCLC;
• Patients previously treated with chemoradiation for limited-stage SCLC: must be treatment with curative intent and have a treatment-free interval of at least 6 months between the last dose of chemotherapy/last course, end of thoracic radiotherapy or chemoradiation and confirmation of ES-SCLC;
• At least two cycles of treatment with Serplulimab in combination with chemotherapy with one or more documented efficacy assessments ;
• Local radiotherapy is allowed for patients indicated for radiotherapy, including but not limited to thoracic radiotherapy, brain radiotherapy.

You may not qualify if:

• Incomplete clinical information, such as no disease course, pathological diagnosis, treatment and observation of outcome data;
• Patients with SCLC and other malignancies.

Sponsors & Collaborators

• Hunan Cancer Hospital: lead

Study Sites (1)

Hunan Cancer Hospital

Changsha, Hunan, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

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

Study Officials

• LIN Wu

  Hunan Cancer Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 27, 2024
• Study Start: February 5, 2024
• Primary Completion: December 30, 2024
• Study Completion: June 6, 2025
• Last Updated: February 27, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)