Tislelizumab with chemotherapy followed by chest consolidation radiotherapy as first-line treatment for extensive-stage small cell lung cancer

A Prospective, Single Arm, Phase II Clinical Study of Tislelizumab Combined With Chemotherapy Followed by Thoracic Consolidation Radiotherapy in the First-line Treatment of Extensive Stage Small Cell Lung Cancer

This trial will test whether adding the immunotherapy drug tislelizumab to standard chemotherapy followed by chest radiation helps people newly diagnosed with extensive-stage small cell lung cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chongqing University Cancer Hospital (Academic / other)
• Drugs / interventions: tislelizumab
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT07425795 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-arm phase II trial enrolling 36 newly diagnosed patients with extensive-stage small cell lung cancer. Participants will receive induction treatment with tislelizumab plus an etoposide-platinum (EP) chemotherapy regimen for 4–6 cycles, followed by an efficacy assessment. Patients who achieve remission will receive thoracic consolidation radiotherapy together with ongoing tislelizumab, then continue tislelizumab maintenance until disease progression, unacceptable toxicity, withdrawal of consent, or up to two years. Key eligibility includes age 18–75, ECOG 0–1, measurable disease by RECIST 1.1, adequate organ function, and no prior systemic treatment for ES-SCLC.

Who should consider this trial

Good fit: Adults aged 18–75 with newly diagnosed extensive-stage small cell lung cancer, ECOG performance status 0–1, measurable disease, adequate organ function, and no prior systemic therapy who can comply with the protocol are the intended candidates.

Not a fit: Patients with poor performance status (ECOG >1), significant organ dysfunction, prior systemic treatment for ES-SCLC, or those unable to receive thoracic radiotherapy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this combined approach could prolong survival and improve chest tumor control for patients with newly diagnosed extensive-stage SCLC.

How similar studies have performed: Large trials have shown that adding PD-1/PD-L1 immunotherapy to first-line chemotherapy can improve survival in ES-SCLC, while the added value of planned thoracic consolidation radiotherapy after chemoimmunotherapy is still being explored.

Eligibility criteria

Inclusion Criteria:

* Signed informed consent;
* Age 18-75 years;
* According to the judgment of the investigator, the patient was able to comply with the study protocol;
* Histologically or cytologically confirmed extensive stage small cell lung cancer (es-sclc) (according to the Veterans Administration lung cancer association \[valg\] staging system);
* No previous systemic treatment for ES-SCLC;
* With measurable lesions assessed by the investigator according to RECIST version 1.1;
* ECOG physical status score was 0 or 1;
* Life expectancy ≥ 3 months;
* Adequate hematology and end organ function, as defined by the following laboratory findings, which should be obtained within 14 days before the first study treatment: absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/l (without granulocyte colony-stimulating factor treatment); Lymphocyte count ≥ 0.5 × 10\^9/l (500 / μ L); Platelet count ≥ 100 × 10\^9/l (100000 / μ L); Hemoglobin ≥ 90g/l (9.0g/dl); Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) ≤ 2.5 × upper limit of normal (ULN), with the following exceptions: Patients with confirmed liver metastasis: AST and alt ≤ 5 × ULN; Patients with confirmed liver or bone metastasis: ALP ≤ 5 × ULN; Total bilirubin ≤ 1.5 × ULN, with the following exceptions: patients known to have Gilbert syndrome: total bilirubin ≤ 3 × ULN; Creatinine clearance ≥ 60ml/min (calculated by Cockcroft Gault formula); Albumin ≥ 25g/l (2.5g/dl).

Exclusion Criteria:

* Symptomatic, untreated, or actively progressive central nervous system (CNS) metastases; ·Patients with CNS lesions who were treated and asymptomatic were eligible for this study if they met all of the following criteria: measurable lesions that met the recistv1.1 definition were outside the CNS; The patient had no history of intracranial hemorrhage or spinal cord hemorrhage; Patients did not receive stereotactic radiotherapy within 7 days before the start of study treatment, whole brain radiotherapy within 14 days before the start of study treatment, or neurosurgical resection within 28 days before the start of study treatment; Patients do not need to continue to receive corticosteroids for CNS disease. Treatment with stable doses of anticonvulsants was allowed. Metastasis was limited to the cerebellum or supratentorial region (i.e., not to the midbrain, pons, medulla oblongata, or spinal cord); There was no evidence of progression between the completion of CNS local therapy and the initiation of study therapy asymptomatic patients with CNS metastases who could be enrolled according to the assessment of other investigators could be enrolled;
* History of leptomeningeal disease;
* Poorly controlled pleural effusion, pericardial effusion or ascites requiring repeated drainage (once a month or more frequently);
* Poorly controlled or symptomatic hypercalcemia (ionized calcium \>1.5mmol/l, calcium \>12mg/dl or corrected calcium \>uln);
* Have active or ever suffered from autoimmune disease or immunodeficiency;
* Have a history of idiopathic pulmonary fibrosis, organized pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia or idiopathic pneumonia;
* Active pulmonary tuberculosis;
* Untreated chronic hepatitis B patients, chronic hepatitis B virus carriers with HBV DNA ≥ 500 iu/ml (2500 copies /ml), active hepatitis C patients: inactive HBsAg carriers, patients with stable active HBV infection after drug treatment (HBV dna\<500 iu/ml (2500 copies /ml)) can be enrolled. HBV DNA testing was only performed in patients who tested positive for hepatitis B core antibody (anti HBC antibody). Patients with negative hepatitis C virus (HCV) antibody test at screening, or patients with positive HCV antibody and negative HCV RNA test at screening can be enrolled in the study. HCV RNA testing will only be performed in patients with positive hepatitis C virus (HCV) antibody. Note: Patients with detectable hepatitis B surface antigen (HBsAg) or detectable HBV DNA should be treated according to treatment guidelines. Patients treated with antiviral drugs at the time of screening should have been treated for \>2 weeks before enrollment and continue to be treated for 6 months after termination of study drug treatment.

Where this trial is running

Chongqing, Chongqing Municipality

• Chongqing University Affiliated Cancer Hospital — Chongqing, Chongqing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Wei Zhou, Professor

Conditions Extensive Stage Small Cell Lung Cancer; Extensive stage small cell lung cancer; tislelizumab; thoracic consolidation radiotherapy; first-line treatment