Using thoracic radiotherapy for extensive stage small cell lung cancer after immunotherapy

An Open-label, Phase II Single Arm Trial of Thoracic Radiotherapy for?ES-SCLC After First Line Treatment With Immune Checkpoint Inhibitors

This study is testing if adding radiation therapy to the treatment of patients with extensive stage small cell lung cancer, who haven't gotten worse after initial immunotherapy and chemotherapy, can help them do better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zhejiang Cancer Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05544149 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of thoracic radiotherapy in patients with extensive stage small cell lung cancer (ES-SCLC) who have not progressed after receiving first-line treatment with immune checkpoint inhibitors and platinum-based chemotherapy. Participants must have residual thoracic lesions and meet specific eligibility criteria, including adequate organ function and performance status. The study aims to determine if adding thoracic radiotherapy can improve outcomes for these patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with extensive stage small cell lung cancer who have not progressed after initial immunotherapy and chemotherapy.

Not a fit: Patients with progressive disease after initial treatment or those with significant comorbidities affecting organ function may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance treatment outcomes for patients with extensive stage small cell lung cancer.

How similar studies have performed: While there have been studies exploring radiotherapy in lung cancer, this specific approach following immunotherapy is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Age at least 18 years.
* ECOG PS 0-1.
* Histological or cytological syndrome of small cell lung cancer, imaging evaluation staging is extensive
* Life expectancy \>= 3 months.
* Patients are non-progressed after 4 dosed of immunotherapy plus platinum based chemotherapy, with residual thoracic lesions
* Palliative radiotherapy were allowed except for TRT, the interval \> 4 weeks
* Adequate organ function prior to enrollment:
* Adequate bone marrow function: white blood cell (WBC) count ≥ 3.0 \* 10 \^ 9/L or neutrophil count ≥ 1.5 \* 10 \^ 9/L, platelet count ≥ 100 \* 10 \^ 9/L and hemoglobin ≥90g/L,;
* Adequate hepatic function: total bilirubin, urea nitrogen and serum creatinine≤ 1.5 x upper limit of normal (ULN). Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.0 ULN;
* Sufficient heart and lung function, EF\>55%FEV1\>50%
* Ability to understand and willingness to provide the informed consent.
* Women of childbearing age and men must agree to use effective contraception during the trial.

Exclusion Criteria:

* History of another malignancy or concurrent malignancy;
* Mixed small cell with non-small cell lung cancer histology;
* History of thoracic radiotherapy;
* Malignant pleural or ascites;
* Patients with leptomeningeal metastasis or uncontrolled brain;
* Severe autoimmune disease: inflammatory bowel disease (including Crohn's disease and ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, Wegener's granulomatosis and related vasculitides.
* Symptomatic interstitial lung disease or clinically active infectious/non-infectious pneumonitis.
* Active infection, congestive heart failure, or any evidence of myocardial infarction, unstable angina pectoris or cardiac arrhythmia within 6 months prior to enrollment.
* The patient is pregnant (confirmed by serum b-HCG if applicable) or is breastfeeding.
* Mental disorders, drug abuse, and social condition that may negatively impact compliance in the investigator's opinion.

Where this trial is running

Hangzhou, Zhejiang

• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Xiaojing Lai — Department of Thoracic Radiotherapy, Zhejiang Cancer Hospital
• Study coordinator: Xiaojing Lai

Conditions SCLC,Extensive Stage