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Alkylating agents

Palifosfamide-tris plus Carboplatin and Etoposide for Small Cell Lung Cancer

Phase 3
Waitlist Available
Research Sponsored by Ziopharm
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented extensive-stage small cell lung cancer.
Patient has received no prior chemotherapy, adjuvant therapy, or radiotherapy for lung cancer.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed every 6 weeks for 22 weeks, then every 12 weeks until a partial or complete response is confirmed
Awards & highlights

Study Summary

This is a multinational, multicenter, randomized controlled, open-label, adaptive study to evaluate the efficacy of PaCE chemotherapy in chemotherapy naive subjects with extensive-stage SCLC. Eligible subjects will be stratified according to age, gender, and Eastern Cooperative Oncology Group (ECOG) performance status, and randomized in a 1:1 ratio to receive either PaCE or CE chemotherapy. The study design uses an adaptive group sequential approach with sample size re-estimation at the interim analysis. Secondary efficacy endpoints include ORR, PFS, duration of response and changes in QOL and disease-related symptoms. Tumor-related endpoints will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines. The safety of study treatments will be assessed by the frequency and severity of adverse events as determined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03. To provide an initial confirmation of safety, an early interim analysis of safety data only will be performed. An independent Data Monitoring Committee (DMC) will be convened to assess the safety and efficacy of the study interventions and to monitor the overall conduct of the clinical trial.

Eligible Conditions
  • Small Cell Lung Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed every 6 weeks for 22 weeks, then every 12 weeks until progressive disease, initiation of alternate anticancer therapy, or 1 year following the last patient enrolled (whichever is soonest)
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed every 6 weeks for 22 weeks, then every 12 weeks until progressive disease, initiation of alternate anticancer therapy, or 1 year following the last patient enrolled (whichever is soonest) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Objective Response Rate (ORR)
Progression Free Survival (PFS)
Quality of Life (QOL) as assessed by EQ-5D-3L and QLQ-LC13
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Palifosfamide-tris plus Carboplatin and EtoposideExperimental Treatment3 Interventions
Drug: palifosfamide-tris in combination with carboplatin and etoposide palifosfamide-tris: 130 mg/m2/day 3 days every 21 days for a max of 6 cycles. carboplatin: AUC 4 mg/mL/min 1 day every 21 days for a max of 6 cycles. etoposide: 100 mg/m2/day 3 days every 21 days for a max of 6 cycles.
Group II: Carboplatin plus EtoposideActive Control2 Interventions
Drug: carboplatin in combination with etoposide carboplatin: AUC 5mg/mL/min 1 day every 21 days for a maximum of 6 cycles. etoposide: 100 mg/m2/day 3 days every 21 days for a maximum of 6 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etoposide
FDA approved
Carboplatin
FDA approved

Find a Location

Who is running the clinical trial?

ZiopharmLead Sponsor
35 Previous Clinical Trials
3,455 Total Patients Enrolled
Alaunos TherapeuticsLead Sponsor
40 Previous Clinical Trials
3,851 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~43 spots leftby Mar 2025