NCT06748495Active, not recruiting
Real-world First-line Serplulimab-based Immunochemotherapy for Extensive-stage Small Cell Lung Cancer
Real-world First-line Serplulimab-based Immunochemotherapy for Extensive-stage Small Cell Lung Cancer: the Multicenter ASTRUM-005R Study
Source: ClinicalTrials.gov · Last updated 27 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 600 (estimated)
- First submitted
- 27 Nov 2024
- Start date
- 5 Feb 2024
- Primary completion date
- 30 Dec 2024
- Lead sponsor
- Hunan Cancer Hospital
- Diseases
- Lung cancer
- NCT number
- NCT06748495
What you commit to
- Study type: Observational
- Planned participants: 600
- From 5 Feb 2024 to the primary completion date, 30 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Incomplete clinical information, such as no disease course, pathological diagnosis, treatment and observation of outcome data;
- Patients with SCLC and other malignancies.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hunan Cancer Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.