A Phase 2 Study to Evaluate LY2603618 in Combination With Pemetrexed in Patients With Advanced or Metastatic Non-small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Overall Tumor Response - Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]
Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
LY2603618 and Pemetrexed
Intervention: LY2603618 (Drug)
LY2603618 and Pemetrexed
Intervention: Pemetrexed (Drug)
Outcomes
Primary Outcomes
Overall Tumor Response - Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]
Time Frame: Baseline until Progressive Disease or Study Discontinuation (Up to 23 Months)
Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.
Secondary Outcomes
- Change in Symptom Burden Scores of Lung Cancer Symptom Scale (LCSS)(Baseline until End of Study (Up to 27.1 Months))
- Percentage of Participants Who Achieved a Best Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Clinical Benefit Rate)(Baseline until Progressive Disease or Study Discontinuation (Up to 23 Months))
- Progression-free Survival (PFS)(Baseline to Progressive Disease or Death Due to Any Cause (Up to 27.1 Months))
- Duration of Response(First Observation of CR or PR until Progressive Disease or Death Due to Any Cause (Up to 23 Months))
- PK: Maximum Plasma Concentration (Cmax) of Pemetrexed(Day 1 and Day 2 of Cycle 1 and Cycle 2: Prior to End of Infusion (EOI); EOI + 1-2 hour (hr); EOI + 4-6- hr; EOI + 20-28 hr)
- PK: Area Under the Plasma Concentration vs. Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY2603618(Day 2 and Day 3 of Cycle 1 and Cycle 2: Prior to End of Infusion (EOI); EOI + 1-2 hr; EOI + 4-6 hr; EOI + 20-28 hr; anytime on Day 8 of Cycle 1 and Cycle 2)
- Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2603618(Day 2 and Day 3 of Cycle 1 and Cycle 2: Prior to End of Infusion (EOI); EOI + 1-2 hr; EOI + 4-6 hr; EOI + 20-28 hr; anytime on Day 8 of Cycle 1 and Cycle 2)
- PK: Area Under the Plasma Concentration vs. Time Curve From Time Zero to Infinity [AUC(0-∞)] of Pemetrexed(Day 1 and Day 2 of Cycle 1 and Cycle 2: Prior to End of Infusion (EOI); EOI + 1-2 hour (hr); EOI + 4-6- hr; EOI + 20-28 hr)