Combining hypofractionated radiotherapy with immunotherapy for limited-stage small-cell lung cancer
Hypofractionated Radiotherapy Combined with Immunotherapy for Limited-stage Small-cell Lung Cancer: a Phase II Trial
PHASE1; PHASE2 · Anhui Provincial Hospital · NCT06527898
This study is testing if a shorter radiation treatment combined with a new immunotherapy can help people with limited-stage small-cell lung cancer live longer without their cancer getting worse.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Anhui Provincial Hospital (other gov) |
| Drugs / interventions | chemotherapy, immunotherapy, Durvalumab, Adebrelimab |
| Locations | 1 site (Hefei, Anhui) |
| Trial ID | NCT06527898 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to enroll 45 patients diagnosed with limited-stage small-cell lung cancer to receive concurrent chemoradiotherapy followed by consolidative immunotherapy with Adebrelimab. The study will utilize hypofractionated radiotherapy, which allows for a shorter treatment duration compared to conventional methods, potentially enabling earlier initiation of immunotherapy. The primary endpoint is progression-free survival, while secondary endpoints include 2-year progression-free survival and overall survival rates. Patients will undergo a specific chemotherapy regimen alongside radiotherapy and will be monitored for safety and efficacy throughout the treatment period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with limited-stage small-cell lung cancer and an ECOG performance status of 0-1.
Not a fit: Patients with extensive-stage small-cell lung cancer or those with non-small cell lung cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates for patients with limited-stage small-cell lung cancer.
How similar studies have performed: Previous studies have shown promising results with hypofractionated radiotherapy and immunotherapy in similar contexts, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-70 years old; * ECOG 0-1; * Adequate organ function to tolerate chemotherapy, immunotherapy and radiotherapy; * Small-cell lung cancer; * Limited stage confirmed by cranial MRI, chest CT, abdominal ultrasonograph, bone scan or cranial MRI and PET-CT; * Signature of inform consent. Exclusion Criteria: * Younger than 18 years old or older than 70 years old; * ECOG\>1; * Inadequate organ function to tolerate chemotherapy, immunotherapy and radiotherapy; * Non-small cell lung cancer and other neuroendocrine carcinoma including typical or atypical carcinoid, large-cell neuroendocrine carcinoma; * Extensive stage confirmed by cranial MRI, chest CT, abdominal ultrasonograph, bone scan or cranial MRI and PET-CT; * No signature of inform consent.
Where this trial is running
Hefei, Anhui
- Anhui Provicial Hospital — Hefei, Anhui, China (RECRUITING)
Study contacts
- Study coordinator: Dong Qian, M.D.
- Email: qiandong@ustc.edu.cn
- Phone: +8619156007756
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Small-cell Lung Cancer, Hypofraction radiotherapy, Small cell lung cancer, immune checkpoint inhibitor