New drug cocktail aims to stall advanced lung cancer
NCT ID NCT06497530
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether a combination of two drugs, lurbinectedin and serplulimab, can help keep extensive-stage small cell lung cancer from growing when used as maintenance therapy after initial chemo-immunotherapy. About 30 adults whose cancer has not worsened after four cycles of standard treatment will receive the combo every three weeks. The main goal is to see how long the cancer stays controlled.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lurbinectedin and serplulimab (drug combination)
- What this could lead to
- If successful, this could offer a new maintenance option to help keep extensive-stage small cell lung cancer under control for longer after initial treatment.
- What could go wrong
- This is a small, early-phase study with only 30 participants, so results may not apply broadly. The combination may cause side effects or fail to improve outcomes over standard care.
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 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Dec 2026
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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria for the Induction Phase: * Fully informed about the study and voluntarily signed a written informed consent form, and able to comply with the requirements and restrictions listed in the informed consent form; * Male or female with age ≥ 18 years; * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1; * Histologically or cytologically confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC) and has not received any systemic treatment for ES-SCLC; * At least one measurable lesion (according to RECIST 1.1 criteria); * Having adequate bone marrow, hepatic, renal and metabolic function, meaning the functional level of the organs meets the following requirements: * Platelet count (PLT) ≥ 100×10\^9/L; Hemoglobin (Hb) ≥ 90 g/L; Absolute neutrophil count (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. * Women of childbearing potential(WOCBP) must have a negative serum pregnancy test before enrollment. WOCBP must use effective contraceptive measure during the trial drug treatment and for 6 months after the last administration. Male patients (with partners of WOCBP) must use effective contraceptive measure during the trial drug treatment and for 4 months after the last administration; * Human immunodeficiency virus (HIV)-negative, with no active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Exclusion Criteria for the Induction Phase: * Have a history of central nervous system (CNS) metastasis or related history; * Have a history of active autoimmune disease or immunodeficiency, or related history; * Have a history of malignancies other than SCLC within 5 years before enrollment; * Previous treatment with immune checkpoint inhibitors or lurbinectedin; * Have a history of idiopathic pulmonary fibrosis or pneumonia, or active pneumonia detected in CT screening; * Treatment with any other investigational product within 28 days before enrollment. Inclusion Criteria for the Maintenance Phase: * Have a continuous response or stable disease according to RECIST 1.1 criteria after 4 cycles of induction therapy; * Toxicity from the induction therapy phase has recovered to ≤ Grade 1; * Have sufficient bone marrow and organ function. Exclusion Criteria for the Maintenance Phase: * Have a history of central nervous system (CNS) metastasis or related history; * Has received chest consolidation radiotherapy; * Severe infection within 2 weeks before enrollment.
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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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The first affiliated hospital of Guangzhou medical university
RECRUITINGGuangzhou, Guangdong, 51000, China
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