Radiotherapy to All Residual Lesions After Chemoimmunotherapy

NCT06479473 | Recruiting Phase 1 DMC

• 1 other identifier: 2024-ky236
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Extensive-stage Small Cell Lung Cancer

Keywords

small-cell lung cancer; extensive-stage; radiotherapy; residual lesion

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  The survival time from diagnose of the disease to progression of the disease

  3 years

Secondary Outcomes (1)

• Overall Survival

  3 years

Study Arms (2)

Chemoimmunotherapy group

ACTIVE COMPARATOR

Patients assigned to chemoimmunotherapy group would receive 4 to 6 cycles of standard chemoimmunotherapy followed by immunotherapy maintenance to 2 years.

Drug: Chemoimmunotherapy

Chemoimmunotherapy with radiotherapy group

EXPERIMENTAL

Patients assigned to chemoimmunotherapy group would receive 4 to 6 cycles of standard chemoimmunotherapy followed by radiotherapy to all residual lesions and immunotherapy maintenance to 2 years.

Radiation: Radiotherapy to all residual lesions; Drug: Chemoimmunotherapy

Interventions

Radiotherapy to all residual lesions RADIATION

Patients assigned to chemoimmunotherapy with radiotherapy group would first receive PET-CT and cranial contrasted MRI to ascertain residual lesions. All residual lesions would be irradiated in a hypofractionated manner.

Chemoimmunotherapy with radiotherapy group

Chemoimmunotherapy DRUG

atients assigned to chemoimmunotherapy group would receive 4 to 6 cycles of chemoimmunotherapy followed by consolidative immunotherapy

Chemoimmunotherapy group; Chemoimmunotherapy with radiotherapy group

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;
• Extensive 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;
• Limited 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 Provincial Hospital

Hefei, Anhui, 230011, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Dong Qian, M.D

  Anhui Provincial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Qian, M.D.

CONTACT

+8619156007756; qiandong@ustc.edu.cn

Xiao-yang Li, M.D.

CONTACT

+8618701851829; drxyl@ustc.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Model Details: All enrolled patients with accordance to the inclusion criteria would first receive 4 to 6 cycles of chemoimmunotherapy (etoposide and cisplatin \& carboplatin with Adebrelimab). Then patients who were evaluated as partial response or stable disease would be assigned randomly to receive radiotherapy to all residual lesions followed by Adebrelimab maintenance or only Adebrelimab maintenance up to 2 years.

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 28, 2024
• Study Start: June 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2026
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)