A Study of LY2940680 in Small Cell Lung Cancer

Study summary

The purpose of this study is to find a recommended dose of LY2940680 that can be safely given in combination with etoposide and carboplatin followed by LY2940680 alone in participants with extensive-disease small cell lung cancer. The study will also compare progression-free survival in participants who are administered etoposide, carboplatin and LY2940680 followed by LY2940680 alone versus etoposide, carboplatin, and placebo followed by placebo alone.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedLY2940680 and Carboplatin

Plus 2 other study approaches.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 28, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?14 U.S. locations

Locations may change over time.

Who runs it?Eli Lilly and Company

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: Eli Lilly and Company
Interventions being studied: Drug: LY2940680; Drug: Carboplatin; Drug: Etoposide; Drug: Placebo

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Small cell lung cancer (SCLC)→

Treatment approach

Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Histological or cytological diagnosis of Small Cell Lung Cancer (SCLC), including malignant pleural effusion that is extensive stage per the International Staging System
Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) performance status schedule
No prior systemic chemotherapy, immunotherapy, or biological therapy for SCLC
Prior radiation therapy allowed to \<25% of the bone marrow. Participants who have received prior radiation to the whole pelvis or chest for the treatment of SCLC are not eligible
At least 1 unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Adequate organ function including the following:
Adequate bone marrow reserve: absolute neutrophil count (ANC) ≥1.5 x 10\^9/ liter (L), platelets ≥100 x 10\^9/L, and hemoglobin ≥9 grams/deciliter (g/dL)
Hepatic: bilirubin ≤1.5 times the upper limit of normal (ULN), alkaline phosphatase (AP), Serum alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤3.0 x ULN (AP, AST, and ALT ≤5 x ULN is acceptable if liver has tumor involvement)
Renal: calculated creatinine clearance (CrCl) ≥50 milliliters per minute (mL/min) based on the standard Cockcroft and Gault formula
Estimated life expectancy of at least 12 weeks
For women: Must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen during and for 6 months after the treatment period; must have a negative serum pregnancy test within 7 days before study enrollment. For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 6 months after the treatment period
Availability of a tumor tissue sample
Able to swallow capsules

Reasons someone may not be able to joinExclusion 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
Have previously participated in a study involving LY2940680
Have previously received treatment with carboplatin or etoposide
Have a mixed histological diagnosis of SCLC and Non-Small Cell Lung Cancer (NSCLC)
Have a serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the participant's ability to adhere to the protocol
Have an active infection \[≥38.5 degrees Celsius and/or receiving Intravenous (IV) antibiotic therapy\]
Have a serious cardiac condition
Have had a prior malignancy other than SCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. Participants with a history of non-metastatic prostate cancer, including biochemical relapse only, will be eligible even if diagnosed less than 5 years previously
Symptomatic central nervous system (CNS) metastases and asymptomatic CNS metastases requiring concurrent corticosteroid therapy. Treated stable CNS metastases are allowed; the participant must be stable after radiotherapy for ≥2 weeks and off of corticosteroids for ≥1 week
Presence of clinically significant third-space fluid collections that cannot be controlled prior to study entry
Significant weight loss (that is, ≥10%) over the 6-week period prior to study entry
Concurrent administration of any other antitumor therapy. An exception will be made for non-metastatic prostate cancer participants continuing androgen blockade therapy only or breast cancer participants continuing adjuvant antiestrogen therapy only (for example, an aromatase inhibitor)
Females who are breastfeeding
Have corrected QT interval (QTc) of \>470 millisecond (msec) on screening electrocardiogram (ECG)
Have received medications that are strong inhibitors of Cytochrome P450 3A4 (CYP3A4) within 7 days prior to receiving study drug

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Highlands Oncology GroupFayetteville, Arkansas
Northeast Georgia Cancer Care, LLCAthens, Georgia
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada
New York Oncology Hematology AssociateAlbany, New York
Mount Sinai Medical CenterNew York, New York
Clinical Research Unit (ITOR) Greenville Hospital SystemGreenville, South Carolina
Accelerated Comm. Oncology Research Network (ACORN)Memphis, Tennessee
The West ClinicMemphis, Tennessee
US OncologyThe Woodlands, Texas
Tyler Cancer CenterTyler, Texas
Northwest Cancer Specialists PCVancouver, Washington
Yakima Valley Memorial HospitalYakima, Washington

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 28, 2018. Always confirm current availability with the study team.

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