NCT03891173

A Study of L-DOS47 in Combination With Vinorelbine/Cisplatin in Lung Adenocarcinoma

A Phase II, Open-Label, Randomized Study Immunoconjugate L-DOS47 in Combination With Vinorelbine/Cisplatin Versus Vinorelbine/Cisplatin Alone in Patients With Lung Adenocarcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Helix BioPharma Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will determine the highest dose of L-DOS47 that can be given in combination with vinorelbine/cisplatin, evaluate safety and tolerability of L-DOS47 when given in combination with vinorelbine/cisplatin, and assess how effective this combination is in treating patients with lung adenocarcinoma compared to patients who are given vinorelbine/cisplatin alone.

Detailed description

The study is divided into two parts. In part I, the maximum tolerated dose of L-DOS47, when given in combination with vinorelbine/cisplatin, will be determined. Cohorts of 3 patients will be recruited into three dosing cohorts (6, 9 and 12 µg/kg). All patients at a given dose level must complete the first treatment cycle (3 week period) before escalation in subsequent patients can proceed. The decision for escalation to the next dose level will be made after the safety data have been reviewed by the Trial Steering Committee (TSC). If a patient in any cohort experiences a dose limiting toxicity, an additional 3 patients will be enrolled, for a maximum of up to 18 patients in this initial dose escalation part of the study. In part II, after the maximum tolerated dose of L-DOS47 in combination with vinorelbine/cisplatin has been determined, a further 118 patients will be randomized (1:1) to receive L-DOS47 in combination with vinorelbine/cisplatin, or vinorelbine/cisplatin alone. Efficacy will be assessed by time to progression (time from first day of study drug administration to documented disease progression), response rate (proportion of patients with a best overall response of complete response and partial response using the Response Evaluation Criteria in Solid Tumours \[RECIST\] version 1.1 criteria), and overall survival (time from first day of study drug administration to death due to any cause). Monitoring will include radiological evaluations every second cycle. Safety and tolerability of L-DOS47 in combination will also continue to be evaluated. For all patients, treatment will continue either until the patient experiences disease progression, unacceptable toxicity, the patient withdraws consent or has completed four treatment cycles.

Conditions

• Lung Adenocarcinoma

Interventions

Type	Name	Description
DRUG	L-DOS47	L-DOS47 lyophilized powder reconstituted and diluted for iv injection
DRUG	Cisplatin	Cisplatin concentrate for solution for iv infusion
DRUG	Vinorelbine	Vinorelbine concentrate for solution for iv infusion

Timeline

• Start date: 2019-02-19
• Primary completion: 2020-05-22
• Completion: 2020-05-22
• First posted: 2019-03-26
• Last updated: 2022-08-12

Locations

4 sites across 2 countries: Poland, Ukraine

Regulatory

• FDA-regulated drug study