Dinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung Cancer

Conditions

• Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dinutuximab — BIOLOGICAL
  Dinutuximab injection, for intravenous (IV) use
• Irinotecan — DRUG
  Irinotecan injection, IV infusion
• Topotecan — DRUG
  Topotecan for injection

Study Details

This is a 2-part, multicenter, open-label, randomized study of dinutuximab and irinotecan versus irinotecan alone in subjects with relapsed or refractory small cell lung cancer (SCLC). Part 1 of the study involves intrasubject dose escalation to evaluate the safety and tolerability of dinutuximab in combination with irinotecan. Part 2 of the study is designed to determine whether dinutuximab plus irinotecan prolongs overall survival (OS) compared with irinotecan alone. Subjects in Part 2 will be randomized in a 2:2:1 fashion to 1 of 3 treatment groups: (A) irinotecan; (B) dinutuximab plus irinotecan; or (C) topotecan. Randomization will be stratified by duration of response to prior platinum therapy (relapse-free period \<3 months or ≥3 months).

Key Dates

Start date

Jun 1, 2017

Status verified

Nov 2020

Primary completion

Jan 27, 2020

Completion

Mar 26, 2020

Study Design

Enrollment

483 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1: Dinutuximab + Irinotecan
  Dinutuximab (10 mg/m\^2 IV) + Irinotecan (350 mg/m\^2 IV) on Day 1 of every 21 days (q21d). Dinutuximab dose will be escalated in 2 mg/m\^2 increments per cycle if maximal pain is \<Grade 2 (and without opioids) and otherwise tolerated, up to a maximum dose of 17.5 mg/m\^2 IV.
• Active Comparator: Part 2: Irinotecan
  Irinotecan (350 mg/m\^2 IV) on Day 1 of each q21d cycle.
• Experimental: Part 2: Dinutuximab + Irinotecan
  Dinutuximab (16 mg/m\^2 IV) + Irinotecan (350 mg/m\^2 IV) on Day 1 of each q21d cycle. Dinutuximab dose will be escalated in 2 mg/m\^2 increments per cycle if maximal pain is \<Grade 2 (and without opioids) and otherwise tolerated, up to a maximum dose of 17.5 mg/m\^2 IV.
• Active Comparator: Part 2: Topotecan
  Topotecan (1.5 mg/m\^2 IV) on Days 1 to 5 of each q21d cycle.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to approximately 2.5 years ]

Locations (40)

Find similar trials in Anchorage, AK

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