Combining chemotherapy and radiotherapy for extensive-stage small-cell lung cancer

Sequential Thoracic Radiotherapy for Extensive-stage Small-cell Lung Cancer Treated with Chemo-immunotherapy Followed by PD-1/PD-L1 Inhibitor Maintenance Therapy：a Phase II, Single Arm, Prospective Trial

This study is testing if adding radiation therapy to ongoing treatment with certain cancer drugs can help people with extensive-stage small-cell lung cancer feel better after their initial chemotherapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Henan Cancer Hospital (Government)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT06586697 on ClinicalTrials.gov

What this trial studies

This Phase II study evaluates the safety and efficacy of sequential thoracic radiotherapy in patients with extensive-stage small-cell lung cancer (ES-SCLC) who have not progressed after 4-6 cycles of platinum-based chemotherapy combined with PD-1/PD-L1 inhibitors. The study is open-label and single-arm, meaning all participants will receive the same treatment without a control group. Patients will undergo thoracic radiotherapy while continuing maintenance therapy with PD-1/PD-L1 inhibitors. The goal is to assess how well this combined approach works in managing ES-SCLC.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with confirmed extensive-stage small-cell lung cancer who have shown no disease progression after initial chemotherapy and PD-1/PD-L1 inhibitor treatment.

Not a fit: Patients with previous immune checkpoint therapy, central nervous system metastasis, or significant liver metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with extensive-stage small-cell lung cancer by enhancing the effectiveness of existing therapies.

How similar studies have performed: Other studies have explored similar combinations of chemotherapy and immunotherapy, showing promising results, but this specific approach is still being evaluated.

Eligibility criteria

Inclusion Criteria:

1. Age between18 years and 75 years.
2. Histologic or cytologic confirmation of extensive-stage small cell lung cancer.
3. Initially treated patients with extensive SCLC showed no disease progression after 4-6 cycles of chemotherapy combined with PD-1/PD-L1 inhibitors.
4. Presence of at least one measurable lesion (according to RECIST v1.1).
5. ECOG performance status of 0 or 1.
6. Life expectancy of at least 3 months.
7. Adequate bone marrow, liver and kidney function.
8. Adequate pulmonary function with FEV1 \>1 L or \>30 % of predicted value and DLCO \>30 % of predicted value

Exclusion Criteria:

1. Previous T cell co-stimulation or immune checkpoint therapy.
2. Previous received chemoradiotherapy for limited-stage SCLC.
3. Central nervous system metastasis with clinical symptoms.
4. Multiple liver metastases (patients with isolated liver metastases, metastatic lesions \< 3cm could be included).
5. Patients with spinal cord compression.
6. Idiopathic pulmonary fibrosis, institutional pneumonia, drug-induced pneumonia or idiopathic pneumonia, or evidence of active pneumonia during screening (patients with active pulmonary tuberculosis couldn't be enrolled).
7. Have received any other investigational drug treatment or participated in another interventional clinical study within 4 weeks prior to signing the informed consent.
8. In the 5 years prior to the study, subjects had prior or concurrent malignancies requiring active treatment.
9. Subjects with any severe and/or uncontrolled disease (hypertension, heart disease, infection, cirrhosis, active hepatitis, AIDS, third space effusion).
10. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
11. Severe allergic reactions to any of the monoclonal antibodies are known to occur.

Where this trial is running

Zhengzhou, Henan

• HenanCH — Zhengzhou, Henan, China (Recruiting)

Study contacts

• Study coordinator: Yang Liu

Conditions Extensive-stage Small-cell Lung Cancer