New hope for tough lung cancer: drug plus radiation combo shows promise in early trial
NCT ID NCT06501976
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tests whether combining a drug called lurbinectedin with radiation therapy is safe for people with small cell lung cancer that has one new tumor after initial treatment. The drug works by damaging cancer cell DNA, similar to radiation. The goal is to see if this combination causes fewer severe side effects than standard treatments. Only 9 participants were enrolled, and the study focuses on safety and how long people live without the cancer growing.
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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 9 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Jun 2027
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 years and older
- 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: * Has fully understood this study, voluntarily signed a written informed consent form, and is able to comply with the requirements and restrictions listed in the informed consent form; * Age ≥ 18 years, Male/female participants; * Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2; * With pathologically confirmed diagnosis of SCLC,with Single-lesion progression after first course treatment; * Has sufficient bone marrow, liver, kidney, and metabolic function, i.e., the functional levels of organs meet the following requirements: * Platelets (PLT) ≥ 100×10\^9/L; * Hemoglobin (Hb) ≥ 90 g/L; * Absolute neutrophil (ANC) ≥ 2.0×10\^9/L; * Regardless of whether liver metastasis is present, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0× upper limit of normal (ULN); * Alkaline phosphatase (ALP) ≤ 5×ULN; * Total bilirubin (TBIL) ≤ 1.5×ULN, and direct bilirubin ≤ 1.0×ULN; * Serum creatinine ≤ 1.5×ULN or creatinine clearance rate ≥ 30 mL/min (calculated using the Cockcroft-Gault formula); * Creatine phosphokinase (CPK) ≤ 2.5×ULN; * Albumin ≥ 3.0 g/dL. * A female of childbearing potential (FCBP) must have a negative serum pregnancy test prior to study entry. Woman of childbearing potential (WOCBP) must use adequate contraception during the test drug treatment period and for 6 months after the final dose. Male patients (with partners of WOCBP) must use adequate contraception for the duration of study participation, and 4 months after completion of administration. Exclusion Criteria: * With concurrent brain metastasis, a history of spinal cord compression, or meningeal metastasis; * Patients with obstructive atelectasis, superior vena cava syndrome requiring surgical/ endoscopic/ interventional treatment; suspected or confirmed pulmonary embolism patients; those with uncontrollable large amounts of pleural effusion, ascites, or pericardial effusion; * Patients known to be allergic to any component of the test drug; * Pregnancy or breastfeeding or WOCBP who has a positive serum pregnancy test; * Comorbidities Requirements: 1. Has unstable angina, myocardial infarction, congestive heart failure (CHF) classified as New York Heart Association (NYHA) II or higher, or other clinically significant cardiovascular diseases currently or within the past year prior to screening; 2. Patients with uncontrolled hypertension (systolic blood pressure greater than 160 mmHg and/or diastolic blood pressure greater than 100 mmHg), or a history of hypertensive crisis or hypertensive encephalopathy; 3. Patients with severe arrhythmias requiring medication; 4. Patients with active infections requiring systemic antibacterial, antifungal, or antiviral treatment within 2 weeks prior to administration; 5. Patients with evidence of bleeding tendencies or coagulation disorders; 6. Patients with other significant diseases judged unsuitable for entry by the investigator.
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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.
Contacts and locations
Locations
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National Cancer Center/Cancer Hospital
Beijing, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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