New combo aims to boost chemo for tough lung cancer
NCT ID NCT04560972
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests a new drug called LB-100 combined with standard chemotherapy and immunotherapy for people with untreated extensive-stage small cell lung cancer. The goal is to find the safest dose and see how well the combination works. Only 3 participants were enrolled to check side effects and tumor response.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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3 people
The number who actually took part.
- Started
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May 2021
- Expected to finish
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Jan 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.
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: * Histologically or cytologically confirmed extensive-stage disease small cell lung carcinoma per the Veterans Administration Lung Study Group (VALG) staging system * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST): Revised RECIST guideline (version 1.1) * Estimated life expectancy of at least 12 weeks * For women: Must be surgically sterile (surgical procedure: bilateral tubal ligation), post-menopausal (at least 12 consecutive months of amenorrhea) or have a negative pregnancy test. Women of childbearing potential must be compliant with a medically approved contraceptive regimen (intrauterine device \[IUD\], birth control pills, or barrier device) during and for 3 months after the treatment period; must have a negative serum or urine pregnancy test within 14 days before study drug treatment and must not be breastfeeding * For men: agreement to remain abstinent or use medically approved contraceptive measures, as defined below: * With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during study therapy and for at least 6 months after the last dose of study therapy to avoid exposing the embryo * A performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale * Absolute neutrophil (segmented and bands) count (ANC) \>= 1.5 x 10/L * Platelets \>= 100 x 10/L * Hemoglobin \>= 9 g/dL * Bilirubin =\< 1.5 times upper limits of normal (ULN) may be enrolled * Alkaline phosphatase (AP), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3.0 times ULN (AP, AST, and ALT =\< 5 times ULN are acceptable if the liver has tumor involvement) * Calculated creatinine clearance (CrCl) \>= 60 mL/min based on the Cockcroft and Gault formula * All subjects must have the ability to understand and the willingness to sign a written informed consent * No prior systemic chemotherapy, immunotherapy, biological, hormonal, or investigational therapy for SCLC Exclusion Criteria: * Currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study * Diagnosis of non-small cell lung cancer (NSCLC) or mixed NSCLC and small cell lung cancer (SCLC) * No prior malignancy other than SCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated 5 or more years prior to study entry with no subsequent evidence of recurrence. Patients with a history of low grade (Gleason score =\< 6 = Gleason group 1) localized prostate cancer will be eligible even if diagnosed less than 5 years prior to study entry * Serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol * Active or ongoing infection during screening requiring the use of systemic antibiotics * Serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease as defined by the New York Heart Association class III or IV * Clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroid medication for 1 week prior to the first dose of study drug and have completed radiation 2 weeks prior to the first dose of study drug * Known or suspected allergy to any agent given in association with this trial * Pregnant or lactating women * History of autoimmune disease, including minor/mild autoimmune disease not requiring immunosuppressants (such as eczema on less than 10% of the body surface area and long term diabetes mellitus type 1 on stable insulin) * Known hepatitis B or hepatitis C * Known human immunodeficiency virus (HIV) positive * Treatment with systemic corticosteroid or other immunosuppressive medication. The use of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension, and low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed * Administration of a live, attenuated vaccine within 28 days prior to study * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients with indwelling catheters are allowed * Uncontrolled or symptomatic hypercalcemia (\> 1.5 mmol/L ionized calcium or calcium \> 12 mg/dL or corrected serum calcium \> ULN). Patients who are receiving denosumab prior to study entry must be willing and eligible to discontinue its use and replace it with a bisphosphonate while in the study * History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted * Prior allogeneic bone marrow transplantation or solid organ transplant * QTcF (Fridericia Correction Formula) \> 470 on 2 out of 3 electrocardiograms (EKG's) * Diagnosis of congenital long QT syndrome * Treatment, within 7 days prior to first dose of study drug, with medications that are known to prolong the QT interval and/or are associated with a risk of torsades de pointes * Treatment with CYP450 substrates within 7 days prior to first dose of study drug * Treatment with nephrotoxic compounds within 7 days prior to first dose of study drug * Treatment with warfarin within 7 days prior to first dose of study drug * Treatment with antiepileptic medications that may increase etoposide clearance (including but not limited to phenytoin, phenobarbital, carbamazepine, and valproic acid) within 7 days prior to first dose of study drug * Treatment with strong P-glycoprotein inhibitors within 7 days prior to first dose of study drug * Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of 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.
Contacts and locations
Locations
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City of Hope Medical Center
Duarte, California, 91010, United States
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