Radiotherapy for residual lesions after chemoimmunotherapy in extensive-stage small cell lung cancer

Chemoimmunotherapy Followed by All-residual-lesions Radiotherapy for Extensive-stage Small-cell Lung Cancer: A Phase I/II Trial

This study is testing if adding radiotherapy to treatment can help people with extensive-stage small cell lung cancer who have responded to chemoimmunotherapy live longer and feel better.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Anhui Provincial Hospital (other gov)
• Drugs / interventions: chemotherapy, immunotherapy, Adebrelimab
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT06479473 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of adding radiotherapy to all residual lesions in patients with extensive-stage small cell lung cancer who have responded to first-line chemoimmunotherapy. A total of 150 patients will be enrolled and randomly assigned to receive either chemoimmunotherapy alone or chemoimmunotherapy followed by radiotherapy. The primary endpoint is progression-free survival, while secondary endpoints include overall survival, objective response rate, duration of response, and disease control rate. Patients will undergo 4 to 6 cycles of chemoimmunotherapy followed by maintenance therapy with Adebrelimab, with those showing partial response or stable disease receiving additional radiotherapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with extensive-stage small cell lung cancer who have adequate organ function and an ECOG performance status of 0-1.

Not a fit: Patients with non-small cell lung cancer or those with limited-stage disease will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates for patients with extensive-stage small cell lung cancer.

How similar studies have performed: Previous studies have shown promising results with the combination of thoracic radiotherapy and chemoimmunotherapy, indicating potential for success in this approach.

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.

Where this trial is running

Hefei, Anhui

• Anhui Provincial Hospital — Hefei, Anhui, China (RECRUITING)

Study contacts

• Principal investigator: Dong Qian, M.D — Anhui Provincial Hospital
• Study coordinator: Dong Qian, M.D.

Conditions: Extensive-stage Small Cell Lung Cancer, small-cell lung cancer, extensive-stage, radiotherapy, residual lesion