Clinical Trial: QUILT-2.013: A Trial of AMG 479 or AMG 102 in Combination With Platinum-based Chemotherapy as First-Line Treatment for Extensive Stage Small Cell Lung Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Amgen Protocol 20060534 - A Phase 1b/2 Trial of AMG 479 or AMG 102 in Combination With Platinum-based Chemotherapy as First-Line Treatment for Extensive Stage Small Cell Lung Cancer

Brief Summary:

This trial is titled "A Phase 1b/2 trial of AMG 479 or AMG 102 with Platinum-Based Chemotherapy as First-Line Treatment for Extensive Stage Small-Cell Lung Cancer (SCLC)."

Part 1, the phase 1b portion of this study, is a multicenter, open-label investigation to identify safe dose levels of either AMG 102 or AMG 479 in combination with etoposide plus cisplatin or carboplatin in subjects with previously untreated extensive stage SCLC.

Part 2, the phase 2 portion of this study, is a multicenter, double-blind, 3-arm investigation to evaluate overall survival of either AMG 102 or AMG 479 in combination with platinum-based chemotherapy.


Detailed Summary:
Sponsor: NantCell, Inc.

Current Primary Outcome:

  • Part 2: To estimate the relative treatment effect of platinum-based chemotherapy and AMG 479, and of platinum-based chemotherapy and AMG 102, compared to platinum-based chemotherapy and placebo as measured by the respective HR for overall survival [ Time Frame: Length of study ]
  • Part 1: The incidence of adverse events and clinical laboratory abnormalities defined as dose limiting toxicities (DLTs). Part 2: Overall survival (OS) [ Time Frame: Length of study ]


Original Primary Outcome: Phase 1: The incidence of adverse events and clinical laboratory abnormalities defined as DLT [ Time Frame: Length of study ]

Current Secondary Outcome:

  • Incidence of adverse events and laboratory abnormalities not defined as DLTs. [ Time Frame: Length of study ]
  • Incidence of anti-AMG 479 and anti-AMG 102 antibody formation [ Time Frame: Length of study ]
  • Pharmacokinetics (Cmax and Cmin for AMG 102 and AMG 479) [ Time Frame: Length of study ]
  • ORR, DOR, TTP, PFS and OS rates at 10, 12, 24 and 36 months [ Time Frame: Length of study ]
  • EORTC QLQ-C30 and EORTC QLQ-LC13 scores [ Time Frame: Length of study ]


Original Secondary Outcome:

  • Phase 1: The incidence of anti-AMG 479 and anti-AMG 102 antibody formation [ Time Frame: Length of study ]
  • Phase 1: PK of AMG 479 and of AMG 102 [ Time Frame: Length of study ]
  • Phase 1: The incidence of adverse events and laboratory abnormalities not defined as DLT. [ Time Frame: Length of study ]


Information By: NantCell, Inc.

Dates:
Date Received: October 23, 2008
Date Started: December 2008
Date Completion:
Last Updated: October 26, 2016
Last Verified: October 2016