NCT06479473 Radiotherapy to All Residual Lesions After Chemoimmunotherapy
| NCT ID | NCT06479473 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Anhui Provincial Hospital |
| Condition | Extensive-stage Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2025-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 150 participants in total. It began in 2024-06-01 with a primary completion date of 2025-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Extensive-stage small-cell lung cancer is a lethal malignancy with an extremely poor prognosis. First-line chemotherapy could only achieve an overall survival of approximately 10 months. CREST study demonstrated that the addition of thoracic radiotherapy to the patients who responded to chemotherapy could increase the 2-year survival rate from 3% to 13%. CASPIAN and IMpower 133 trials have established the standard modality of first-line chemoimmunotherapy for extensive-stage small-cell lung cancer and prolonged the overall survival to 13 months. Both the addition of thoracic radiotherapy and immunotherapy to chemotherapy were able to improve the survival. Recently, several retrospective studies have demonstrated the effectiveness and safety of the combination of thoracic radiotherapy and chemoimmunotherapy. In a prospective study, 4-6 cycles of first-line chemotherapy with Adebrelimab followed by thoracic radiotherapy achieved the progression-free survival of 10.1 months and overall survival of 21.4 months, which was longer than chemoimmunotherapy. Another study demonstrated not only thoracic radiotherapy, but also radiotherapy to metastatic lesions could ameliorate survival. Therefore, we supposed that whether radiotherapy to all residual lesions after first-line chemoimmunotherapy could further improve survival for patients with extensive-stage small-cell lung cancer.
Eligibility Criteria
Inclusion Criteria: * 18-70 years old; * ECOG 0-1; * Adequate organ function to tolerate chemotherapy, immunotherapy and radiotherapy; * Small-cell lung cancer; * Extensive 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; * Limited stage confirmed by cranial MRI, chest CT, abdominal ultrasonograph, bone scan or cranial MRI and PET-CT; * No signature of inform consent.
Contact & Investigator
Dong Qian, M.D
PRINCIPAL INVESTIGATOR
Anhui Provincial Hospital
Frequently Asked Questions
Who can join the NCT06479473 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Extensive-stage Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06479473 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06479473 currently recruiting?
Yes, NCT06479473 is actively recruiting participants. Contact the research team at qiandong@ustc.edu.cn for enrollment information.
Where is the NCT06479473 trial being conducted?
This trial is being conducted at Hefei, China.
Who is sponsoring the NCT06479473 clinical trial?
NCT06479473 is sponsored by Anhui Provincial Hospital. The principal investigator is Dong Qian, M.D at Anhui Provincial Hospital. The trial plans to enroll 150 participants.
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