New combo therapy shows promise for tough lung cancer
NCT ID NCT07425795
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new treatment for people with extensive stage small cell lung cancer, a fast-growing cancer that has spread. Participants first get a drug called tislelizumab plus chemotherapy, then chest radiation if the cancer shrinks, followed by maintenance tislelizumab for up to 2 years. The goal is to see how long the cancer stays under control. About 36 newly diagnosed adults will take part.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chongqing University Affiliated Cancer Hospital
RECRUITINGChongqing, Chongqing Municipality, 400000, China
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Other studies related to the condition(s) this trial covers.
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