A Study of LY2510924 in Participants With Extensive-Stage Small Cell Lung Carcinoma

Summary

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)

Timeline

Start

2011-09

Primary completion

2014-01

Completion

2016-08

Outcome

Missed primary endpoint

registry analysis (superiority test); LY2510924 + Carboplatin + Etoposide vs Carboplatin + Etoposide; p = 0.8072; Hazard Ratio (HR) 1.0608 (95% CI 0.6598 to 1.7055); Logrank Test NCT01439568 ↗

paper CONCLUSION: LY2510924 did not improve efficacy but had an acceptable toxicity profile when added to SOC for ED-SCLC. PMID 28236984 ↗

Publications

• Ventz 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.
• Salgia 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	LY2510924	Peptide	20 mg	Subcutaneous
Background	Carboplatin	Small molecule	5 unknown	Intravenous
Background	Etoposide	Small molecule	100 mg/m2	Intravenous

Indications