Hypofractionated Radiotherapy Combined with Immunotherapy for Limited-stage Small-cell Lung Cancer

NCT06527898 | Recruiting Phase 1 DMC

• 1 other identifier: 2024-ky302
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Concurrent chemoradiotherapy has long been the standard modality for locally advanced small-cell lung cancer, which could achieve median overall survival of 25 mos. Conventional fractionation of 66Gy/33f and hyperfractionation of 45Gy/30f twice daily have been acknowledged as the two standard radiotherapy modalities according to CONVERT study. With the introduction of immune checkpoint inhibitors, ADRIATIC study concluded that consolidative Durvalumab after concurrent chemoradiotherapy could achieve a far longer median overall survival of 55.9 months compared with 33.4 months for concurrent chemoradiotherapy. Recently, several studies have demonstrated the safety and efficacy of hypofractionated radiotherapy (3 to 4 Gy) for limited-stage small-cell lung cancer. Hypofractionated radiotherapy processes the advantage of short treatment duration compared with conventional fractionated radiotherapy, which may allow the early participation of immunotherapy. Therefore, we suppose that whether hypofractionated radiotherapy combined with immunotherapy could improve the survival of limited-stage of small-cell lung cancer.

Conditions

Small-cell Lung Cancer

Keywords

Hypofraction radiotherapy, Small cell lung cancer, immune checkpoint inhibitor

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  progression-free survival

  1 to 2 years

Secondary Outcomes (2)

• 2-year progression-free survival rate

  2 year

• 2-year overall survival rate

  2 year

Interventions

hypofractionated radiotherapy with immunotherapy DRUG

hypofractionated radiotherapy with Adebrelimab consolidation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

Anhui Provicial Hospital

Hefei, Anhui, 230011, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Central Study Contacts

Dong Qian, M.D.

CONTACT

+8619156007756; qiandong@ustc.edu.cn

Xiao-Yang Li

CONTACT

+8618701851829; drxyl@ustc.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Hypofractionated radiotherapy combined with immunotherapy

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: July 30, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)