Phase II Small cell lung cancer: ADI-PEG + gemcitabine + docetaxel for Small-cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Small-cell Lung Cancer+5 More
Docetaxel - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

In this study, patients with small cell or non-small cell lung cancer will receive ADI-PEG 20, gemcitabine, and docetaxel after demonstrated progression on frontline therapy. In phase I of the study, up to 6 dose levels will be tested to find the recommended phase II dose (RP2D), after which patients enrolling to phase II will be treated at that dose level to assess efficacy. Although safety and tolerability has been previously determined in the sarcoma population, dose de-escalations of the chemotherapies in that patient population were required. Therefore, a phase I portion will be incorporated to determine the RP2D of the triplet in this population.

Eligible Conditions
  • Small-cell Lung Cancer
  • Non-Small Cell Lung Carcinoma (NSCLC)
  • Non-small Cell Lung Cancer
  • Small Cell Lung Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 4 Secondary · Reporting Duration: Through the first 4 weeks of treatment for all Phase I enrolled participants (estimated to be 12 months and 4 weeks)

Week 106
Therapeutic procedure
Week 362
Non-Small Cell Lung Carcinoma
Non-Small Cell Lung Carcinoma
Non-Small Cell Lung Carcinoma
Week 102
Non-Small Cell Lung Carcinoma
Non-Small Cell Lung Carcinoma
Month 12
Recommended phase II dose (Phase I only)

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Phase II Small cell lung cancer: ADI-PEG + gemcitabine + docetaxel
1 of 3
Phase II Non-small cell lung cancer: ADI-PEG + gemcitabine + docetaxel
1 of 3
Phase I: ADI-PEG + gemcitabine + docetaxel
1 of 3

Experimental Treatment

108 Total Participants · 3 Treatment Groups

Primary Treatment: Phase II Small cell lung cancer: ADI-PEG + gemcitabine + docetaxel · No Placebo Group · Phase 1 & 2

Phase II Small cell lung cancer: ADI-PEG + gemcitabine + docetaxelExperimental Group · 3 Interventions: Docetaxel, ADI-PEG 20, Gemcitabine · Intervention Types: Drug, Drug, Drug
Phase II Non-small cell lung cancer: ADI-PEG + gemcitabine + docetaxelExperimental Group · 3 Interventions: Docetaxel, ADI-PEG 20, Gemcitabine · Intervention Types: Drug, Drug, Drug
Phase I: ADI-PEG + gemcitabine + docetaxelExperimental Group · 3 Interventions: Docetaxel, ADI-PEG 20, Gemcitabine · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~8840
ADI-PEG 20
2013
Completed Phase 2
~190
Gemcitabine
2017
Completed Phase 3
~2940

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through the first 4 weeks of treatment for all phase i enrolled participants (estimated to be 12 months and 4 weeks)

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,793 Previous Clinical Trials
2,274,450 Total Patients Enrolled
1 Trials studying Small-cell Lung Cancer
30 Patients Enrolled for Small-cell Lung Cancer
Polaris GroupIndustry Sponsor
20 Previous Clinical Trials
1,624 Total Patients Enrolled
Brian A Van Tine, M.D., Ph.D.Principal InvestigatorWashington University School of Medicine
5 Previous Clinical Trials
238 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are at least 18 years old.
You have a total bilirubin level of less than 2.0 x IULN, or less than 3.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 2nd, 2021

Last Reviewed: November 9th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.