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PD-1 Inhibitor

Phase 1 Dose Escalation for Non-Small Cell Lung Cancer (PIL Trial)

Phase 1 & 2
Waitlist Available
Led By Zhonglin Hao, MD, PhD
Research Sponsored by Asha Nayak
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 18 weeks - 2 years
Awards & highlights

PIL Trial Summary

This trial is testing a new combination treatment for lung cancer that has stopped responding to immune therapy. The goal is to see if adding another immune modulator will increase response rates.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Metastasis
  • Recurrence

PIL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 weeks - 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 weeks - 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Dose-Limiting Toxicity (DLT) Events as Assessed by CTCAE v4.03
Secondary outcome measures
Dose-Finding Assessment for Optimum Dose of Idelalisib in Combination With Pembrolizumab
Overall Response Rates (ORR) to Combination Therapy

PIL Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase 2 EfficacyExperimental Treatment2 Interventions
All patients in the efficacy assessment phase will be treated with pembrolizumab (200 mg intravenously every 3 weeks) in combination with oral idelalisib (dose not exceeding 150 mg twice daily, per the phase 1 assessment) for 18 weeks before maintenance with pembrolizumab 200 mg intravenously every 3 weeks for up to 2 years, until disease progression or unacceptable toxicity.
Group II: Phase 1 Dose EscalationExperimental Treatment2 Interventions
Sequential cohorts of 3 patients will receive pembrolizumab 200 mg intravenously every 3 weeks, in addition to the oral drug, idelalisib, every day for 21 days. The first group of 3 will receive idelalisib 50 mg twice daily; the next cohort will receive idelalisib 100 mg twice daily; the last cohort will receive idelalisib 150 mg twice daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Idelalisib
FDA approved
Pembrolizumab
FDA approved

Find a Location

Who is running the clinical trial?

Gilead SciencesIndustry Sponsor
1,084 Previous Clinical Trials
848,475 Total Patients Enrolled
Asha NayakLead Sponsor
1 Previous Clinical Trials
31 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,890 Previous Clinical Trials
5,060,297 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Pembrolizumab + Idelalisib for Lung Cancer Study
Asha Nayak 2017. "Pembrolizumab + Idelalisib for Lung Cancer Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03257722.
~1 spots leftby Apr 2025
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