Hypofraction radiotherapy for advanced lung cancer
Hypofraction Radiotherapy Followed by Immune Checkpoint Inhibitors for Locally Advanced Non-small Cell Lung Cancer: A Phase I/II Trial
This study is testing if a new type of radiation treatment followed by immune therapy can help people with advanced lung cancer live longer and feel better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Anhui Provincial Hospital Government |
| Drugs / interventions | durvalumab, chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Hefei, Anhui) |
| Trial ID | NCT05269485 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and primary efficacy of hypofraction radiotherapy followed by immune checkpoint inhibitors in patients with stage III locally advanced non-small cell lung cancer. A total of 36 patients will be enrolled, receiving either high-dose or low-dose fractionated radiotherapy before undergoing a year of maintenance therapy with immune checkpoint inhibitors. The study seeks to improve local control rates and overall survival compared to existing treatment modalities.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with stage III locally advanced non-small cell lung cancer who are surgically unresectable or have declined surgery.
Not a fit: Patients with small-cell lung cancer, other neuroendocrine carcinomas, or those with mutant types of driven genes may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance local control and overall survival rates for patients with advanced non-small cell lung cancer.
How similar studies have performed: Previous studies have shown that hypofraction radiotherapy can improve local control rates, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-70 years old; * Eastern Cooperative Oncology Group (ECOG) 0-1; * Non-small cell lung cancer including squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma, large-cell carcinoma; * Wild-type of driven genes; * Stage III (AJCC 8th Edition) confirmed by cranial MRI, chest CT, abdominal ultrasonograph, bone scan or cranial MRI and d Positron Emission Tomography (PET-CT); * Surgically unresectable or deny of surgery; * Signature of inform consent. Exclusion Criteria: * Younger than 18 years old or older than 70 years old; * ECOG\>1; * Small-cell lung cancer and other neuroendocrine carcinoma including typical or atypical carcinoid, large-cell neuroendocrine carcinoma; * Mutant type of driven genes; * Non-stage III (AJCC 8th Edition) confirmed by cranial MRI, chest CT, abdominal ultrasonograph, bone scan or cranial MRI and PET-CT; * Surgically resectable; * No signature of inform consent.
Where this trial is running
Hefei, Anhui
- Anhui Provicial Hospital — Hefei, Anhui, China (Recruiting)
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.