Pegilodecakin + Pembrolizumab for Non-Small Cell Lung Cancer (Cypress 1 Trial)

Phase 2

Waitlist Available

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of response to death due to any cause (up to 24 months)

Awards & highlights

No Placebo-Only Group

Summary

To compare the efficacy of pegilodecakin in combination with pembrolizumab versus pembrolizumab alone in participants with metastatic non-small cell lung cancer as measured by objective response rate.

Eligible Conditions

Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of response to death due to any cause (up to 24 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of response to death due to any cause (up to 24 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of response to death due to any cause (up to 24 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants Who Achieved an Objective Response Rate (ORR)

Secondary study objectives

Duration of Response (DOR)

Overall Survival (OS)

Percentage of Participants Who Achieved a Disease Control Rate (DCR)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pegilodecakin + PembrolizumabExperimental Treatment2 Interventions

Participants received pegilodecakin subcutaneously (SQ) at 0.8 milligrams (mg) (≤80 kilograms (kg) body weight) or 1.6 mg (\>80 kg body weight) once daily (QD) in the abdomen, thigh or back of upper arm. Pembrolizumab administered as an intravenous (IV) infusion at 200 mg on Day 1 of a 21-day cycle.

Group II: PembrolizumabActive Control1 Intervention

Participants received pembrolizumab as an IV infusion at 200 mg on Day 1 of a 21-day cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

FDA approved

Pegilodecakin

Not yet FDA approved

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