Promising new cocktail takes on tough lung cancer
NCT ID NCT07358676
First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times
Summary
This study tests a new treatment for people with extensive-stage small cell lung cancer who have not had treatment before. The approach combines the drug bemotuzumab with standard chemotherapy and another drug called anlotinib, followed by chest radiation. The goal is to see if this combination can delay cancer growth and be safe for about 25 participants.
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 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Jan 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.
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:\*\* 1. Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) per VALG staging. 2. No prior systemic therapy for ES-SCLC. 3. At least one measurable lesion as defined by RECIST 1.1 criteria. 4. Age 18-75 years. 5. ECOG performance status of 0-2. 6. Life expectancy of ≥3 months. 7. Adequate hematologic and organ function: * Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L. * Platelet count ≥ 100 × 10\^9/L. * Hemoglobin ≥ 80 g/L. * Creatinine clearance ≥ 50 mL/min. * Total bilirubin ≤ 1.5 × upper limit of normal (ULN). * AST and ALT ≤ 2.5 × ULN. * Albumin ≥ 28 g/L. * INR and APTT ≤ 1.5 × ULN. * Left ventricular ejection fraction (LVEF) ≥ 50%. 8. For females of childbearing potential: negative serum pregnancy test within 3 days prior to dosing and agreement to use highly effective contraception. 9. For males: agreement to use barrier contraception. 10. Willing and able to provide written informed consent and comply with study procedures. \*\*Exclusion Criteria:\*\* 1. Symptomatic brain metastases. (Asymptomatic, treated, and stable brain metastases for ≥1 month without steroids are allowed). 2. Prior thoracic radiotherapy for SCLC. 3. Prior treatment with anti-angiogenic agents (e.g., anlotinib, bevacizumab) or anti-PD-1/PD-L1 therapies. 4. Factors affecting oral medication intake (e.g., inability to swallow, major gastrointestinal resection). 5. Uncontrolled effusions requiring repeated drainage (pleural, pericardial, or ascites). 6. Imaging evidence of tumor invasion of major blood vessels or high risk of fatal hemorrhage as judged by the investigator. 7. History of significant bleeding tendency or coagulopathy, including clinically significant hemoptysis (\>1 tablespoon daily within 3 months) or significant bleeding within 4 weeks prior to enrollment. 8. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment. 9. Arterial/venous thrombotic events within 6 months prior to enrollment (e.g., cerebrovascular accident, deep vein thrombosis, pulmonary embolism). 10. Active autoimmune disease requiring systemic treatment within 2 years prior to first dose. 11. Any other condition that, in the investigator's judgment, increases risk or renders the patient unsuitable for the study.
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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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Tianjin Medical University Cancer Institute & Hospital
RECRUITINGTianjin, Tianjin Municipality, 300000, China
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