Clinical trial · Interventional
A Study of LY2510924 in Participants With Extensive-Stage Small Cell Lung Carcinoma
A Randomized Phase 2 Study of LY2510924 and Carboplatin/Etoposide Versus Carboplatin/Etoposide in Extensive-Stage Small Cell Lung Carcinoma
NCT01439568CI-TRIAL-00039653completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this trial is to compare the progression free survival of LY2510924 + carboplatin + etoposide therapy versus carboplatin + etoposide therapy in participants with extensive-stage disease small cell lung cancer (SCLC)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extensive Stage Small Cell Lung Carcinoma | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| LY2510924 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LY2510924 + Carboplatin + Etoposide
- description
- LY2510924: 20 milligram (mg) administered once daily as a subcutaneous(SC) injection on days 1 to 7 of the 21 day cycle; repeat every 21 days for 6 cycles. Carboplatin: 5 milligram/millimeter/per minute (mg/mL/min) area under the curve (AUC) administered intravenously on day 1 of the 21 day cycle; repeat every 21 days for 6 cycles. Etoposide: 100 milligram square meter (mg/m\^2) administered intravenously on days 1 to 3 of the 21 day cycle; repeat every 21 days for 6 cycles.
- interventionNames
- Drug: LY2510924
- Drug: Carboplatin
- Drug: Etoposide
- type
- ACTIVE_COMPARATOR
- label
- Carboplatin + Etoposide
- description
- Carboplatin: 5 mg/mL/min area under the curve administered intravenously on day 1 of the 21 day cycle; repeat every 21 days for 6 cycles. Etoposide: 100 milligram square meter (mg/m\^2) administered on days 1 to 3 of the 21 day cycle; repeat every 21 days for 6 cycles.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically or cytologically confirmed extensive-stage disease small cell lung carcinoma * measurable disease as defined by the New Response Evaluation Criteria in Solid Tumors (RECIST): Revised RECIST Guideline (version 1.1) * no prior systemic chemotherapy, immunotherapy, biological, hormonal, or investigational therapy for SCLC * a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale * adequate organ function, including: * hematologic: absolute neutrophil (segmented and bands) count (ANC) greater than or equal to (≥)1.5 x 10\^9/ liter (L), platelets ≥100 x 10\^9/L, and hemoglobin ≥9 grams per deciliter (g/dL). * hepatic: bilirubin less than or equal to (≤)1.5 times upper limits of normal (ULN), and alkaline phosphatase (AP), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 times ULN (AP, AST, and ALT ≤5 times ULN is acceptable if liver has tumor involvement * renal: calculated creatinine clearance (CrCl) ≥45 milliliters per minute (mL/min) based on the standard Cockcroft and Gault formula * For women: Must be surgically sterile (surgical procedure: bilateral tubal ligation), post-menopausal (at least 12 consecutive months of amenorrhea), or compliant with a medically approved contraceptive regimen (intrauterine device \[IUD\], birth control pills, or barrier device) during and for 6 months after the treatment period; must have a negative serum or urine pregnancy test within 7 days before study enrollment, and must not be breast-feeding. For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 6 months after the treatment period. * estimated life expectancy of at least 12 weeks * written informed consent prior to any study-specific procedures * able and willing to learn to self-administer LY2510924, or have a caregiver who is willing to learn and able to administer LY2510924 by subcutaneous (SC) injection 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 * prior treatment with carboplatin/etoposide or LY2510924 * any concurrent administration of any other antitumor therapy * 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. Participants with a history of low grade (Gleason score ≤6) 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 participant's ability to adhere to the study requirements * 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 central nervous system (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
References
Publications (3)
- DERIVEDMarzano L, Darwich AS, Dan A, Tendler S, Lewensohn R, De Petris L, Raghothama J, Meijer S. Exploring the discrepancies between clinical trials and real-world data: A small-cell lung cancer study. Clin Transl Sci. 2024 Aug;17(8):e13909. doi: 10.1111/cts.13909. PMID 39113428
- DERIVEDVentz S, Khozin S, Louv B, Sands J, Wen PY, Rahman R, Comment L, Alexander BM, Trippa L. The design and evaluation of hybrid controlled trials that leverage external data and randomization. Nat Commun. 2022 Oct 2;13(1):5783. doi: 10.1038/s41467-022-33192-1. PMID 36184621
- DERIVEDSalgia R, Stille JR, Weaver RW, McCleod M, Hamid O, Polzer J, Roberson S, Flynt A, Spigel DR. A randomized phase II study of LY2510924 and carboplatin/etoposide versus carboplatin/etoposide in extensive-disease small cell lung cancer. Lung Cancer. 2017 Mar;105:7-13. doi: 10.1016/j.lungcan.2016.12.020. Epub 2016 Dec 31. PMID 28236984