Phase 2 N=55 Treatment

A Study of Advanced or Metastatic Non-small Cell Lung Cancer

Non Small Cell Lung Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00988858 ↗

Enrolled (actual)

Serious AEs

29.1%

Results posted

Aug 2017

Primary outcome: Primary: Overall Tumor Response - Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] — 9.1 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: LY2603618 (Drug); Pemetrexed (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: Jul 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Tumor Response - Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]	9.1	—
SECONDARY Percentage of Participants Who Achieved a Best Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Clinical Benefit Rate)	45.5	—
SECONDARY Progression-free Survival (PFS)	2.3	—
SECONDARY Duration of Response	8.7	—
SECONDARY Change in Symptom Burden Scores of Lung Cancer Symptom Scale (LCSS)	12; 6; 18; 10	—
SECONDARY Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2603618	3430; 3560	—
SECONDARY PK: Maximum Plasma Concentration (Cmax) of Pemetrexed	102; 96.8	—
SECONDARY PK: Area Under the Plasma Concentration vs. Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY2603618	38000; 41500	—
SECONDARY PK: Area Under the Plasma Concentration vs. Time Curve From Time Zero to Infinity [AUC(0-∞)] of Pemetrexed	193; 202	—

Summary

The primary purpose of this study is to evaluate the efficacy and safety of LY2603618 in combination with pemetrexed and any side effects that might be associated with it along with determining the effects of LY2603618 in combination with pemetrexed in participants with advanced or metastatic Non-small Cell Lung Cancer (NSCLC).

Eligibility Criteria

Inclusion Criteria

Must agree to have a tumor biopsy at screening
Must have a diagnosis of advanced or metastatic non-squamous non-small cell lung cancer that has progressed after certain prior treatment
Must be available for the duration of the study and willing to follow the study procedures
If participant is a woman that is capable of having children, must have a negative pregnancy test within 7 days of taking first dose of study drug
Must have discontinued radiation therapy at least 4 weeks before entering this study

Exclusion Criteria

Must not have taken an unapproved drug as treatment for any indication within the last 28 days before starting study treatment.
Must not be pregnant or lactating, are considering becoming pregnant, or are considering fathering a child. Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial until the participant's physician considers it safe to become pregnant or father a child.
Must not have known positive test in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb).
Must not have previously participated in a study involving LY2603618
Must not have previously taken pemetrexed for cancer
Must not have a known allergy to LY2603618 or pemetrexed
Must not currently have an infection that may affect participant's ability to tolerate the therapy
Must not have a serious medical condition or disorder that would make it unsafe for you to participate in the study such as uncontrolled diabetes or chest pain due to heart disease
If taking certain medications called non-steroidal anti-inflammatory drugs (NSAIDS), such as ibuprofen, must be able to stop taking these medications according to certain guidelines

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00988858). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.