Radiotherapy for advanced small cell lung cancer after chemotherapy and immunotherapy

A Phase I Dose Escalation Study of Thoracic Consolidation Radiotherapy for Extensive-stage Small Cell Lung Cancer Patients Treated With Chemo-immunotherapy

This study is testing whether different doses of radiation therapy can help people with advanced small cell lung cancer who have already had chemotherapy and immunotherapy feel better and live longer.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, atezolizumab, dulvumab, Serplulimab
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06187740 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety of different doses of thoracic consolidation radiotherapy in patients with extensive-stage small cell lung cancer (ES-SCLC) who have responded to standard first-line chemotherapy combined with immunotherapy. The study will recruit patients who have undergone at least four cycles of treatment and have residual thoracic lesions. By assessing the impact of radiotherapy on reducing thoracic recurrence and improving overall survival, the trial builds on previous findings that suggest potential benefits of this approach. The trial is being conducted at Fudan University Shanghai Cancer Center.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with pathologically confirmed extensive-stage small cell lung cancer who have shown a response to first-line chemotherapy and immunotherapy.

Not a fit: Patients with other malignancies or those who do not meet the specific inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve survival rates and reduce the risk of recurrence in patients with extensive-stage small cell lung cancer.

How similar studies have performed: Previous studies, such as the CREST study, have shown success with similar approaches, indicating the potential effectiveness of thoracic radiotherapy in this patient population.

Eligibility criteria

Inclusion Criteria:

Inclusion criteria:

1. age ≥ 18 years;
2. ECOG performance status score 0-2 points;
3. pathologically confirmed small cell lung cancer;
4. complete baseline imaging data (including brain enhanced MRI/CT, PET-CT or chest enhanced CT + bone scan + neck and abdominal B ultrasound/CT) before first-line treatment;
5. stage extensive-stage SCLC at initial diagnosis, and first-line treatment received standard platinum-based doublet chemotherapy combined with immunotherapy (PD-1 or PD-L1) for at least 4 cycles after the efficacy assessment of SD or PR (residual lesions assessed by chest CT);
6. no history of other malignancies;
7. reproductive age male/female agreed to contraception during the trial (surgical ligation or oral contraceptives/intrauterine devices + condom contraception);
8. life expectancy ≥ 3 months
9. 1 week before enrollment, the investigator judged that the patient could continue immune maintenance therapy at the same time, And the organ function level meets the following criteria:

1) bone marrow function: hemoglobin ≥ 80 g/L, white blood cell count ≥ 4.0 \* 10 \^ 9/L or neutrophil count ≥ 1.5 \* 10 \^ 9/L, platelet count ≥ 100 \* 10 \^ 9/L; 2) liver: serum total bilirubin level ≤ 1.5 times the upper limit of normal, when serum total bilirubin level \> 1.5 times the upper limit of normal direct bilirubin level must be ≤ the upper limit of normal,Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times of the upper limit of normal; serum albumin ≥ 27 g/L; 3) Kidney: serum creatinine level \< 1.5 times of the upper limit of normal or creatinine clearance ≥ 50 ml/min, urea nitrogen ≤ 200 mg/L; 10.Patients must have the ability to understand and voluntarily sign an informed consent form.

Exclusion Criteria:

1. baseline pathological examination found mixed with non-small cell lung cancer components;
2. patients who had used any anti-tumor therapy before the diagnosis of ES-SCLC;
3. patients who had received anti-tumor therapy other than standard chemotherapy + immunotherapy regimen;
4. patients who had PD assessed by chemotherapy combined with immunotherapy efficacy;
5. patients who had no residual thoracic lesions (lung, mediastinal and supraclavicular metastatic lymph nodes, thoracic efficacy CR) on chest enhanced CT during efficacy assessment;
6. patients with severe immune-related toxicities after treatment;
7. symptomatic interstitial lung disease or active infection/non-infectious pneumonia;
8. patients who required long-term use of cortisol or immunosuppressive agents;
9. allergic to PD-1 or PD-L1 monoclonal antibody immunotherapy or other causes of inability to perform immune maintenance therapy;
10. lactating or pregnant women;
11. patients with severe autoimmune diseases: active inflammatory bowel disease (including Crohn 's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener' s granulomatosis), etc.;
12. researchers believe that physical examination or clinical trials may interfere with the results or increase the risk of treatment complications, or other uncontrollable diseases;
13. patients with mental illness, substance abuse, social problems affecting compliance are not enrolled after the doctor 's review.

Where this trial is running

Shanghai, Shanghai

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Xiao Chu

Conditions Small Cell Lung Cancer Extensive Stage; small cell lung cancer; chemotherapy; immunotherapy; thoracic radiotherapy