QUILT-2.017: Phase 1b/2 Study of AMG 479 in Combination With Paclitaxel and Carboplatin for 1st Line Treatment of Advanced Squamous Non-Small Cell Lung Cancer

A Phase 1b/2 Study of AMG 479 in Combination With Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Squamous Non-Small Cell Lung Cancer

This is a global, multicenter, 2-part, open-label phase 1b and single-arm phase 2 study designed to evaluate the safety and efficacy of AMG 479 in combination with paclitaxel and carboplatin for the first-line treatment of advanced squamous non-small cell lung carcinoma.

Study Overview

• Status: Terminated
• Conditions: Advanced Squamous Non-Small Cell Lung Cancer
• Intervention / Treatment: Biological: AMG 479; Biological: AMG 479; Drug: Carboplatin; Biological: AMG 479; Drug: Paclitaxel

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Research Site
    • Fayetteville, Arkansas, United States
      • Research Site
  • Indiana
    • Fort Wayne, Indiana, United States
      • Research Site
    • Fort Wayne, Indiana, United States, 46845
      • Research Site
    • Indianaplolis, Indiana, United States, 46256
      • Research Site
    • Indianaplolis, Indiana, United States
      • Research Site
    • Indianapolis, Indiana, United States, 46202
      • Research Site
    • Indianapolis, Indiana, United States
      • Research Site
    • Lafayette, Indiana, United States
      • Research Site
    • Lafayette, Indiana, United States, 47905
      • Research Site
    • New Albany, Indiana, United States
      • Research Site
    • New Albany, Indiana, United States, 47150
      • Research Site
  • Kentucky
    • Paducah, Kentucky, United States, 42003
      • Research Site
    • Paducah, Kentucky, United States
      • Research Site
  • Missouri
    • St. Louis, Missouri, United States
      • Research Site
    • St. Louis, Missouri, United States, 63110-1093
      • Research Site
  • North Carolina
    • Winston Salem, North Carolina, United States
      • Research Site
    • Winston Salem, North Carolina, United States, 27103
      • Research Site
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • Research Site
    • Bethlehem, Pennsylvania, United States
      • Research Site
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Research Site
    • Greenville, South Carolina, United States
      • Research Site
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Research Site
    • Memphis, Tennessee, United States
      • Research Site
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Research Site
    • Madison, Wisconsin, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histologically or cytologically confirmed advanced squamous NSCLC
• Measurable disease as defined per modified RECIST criteria
• ECOG performance status of 0 or 1
• ≥18 years old
• Adequate glycemic function, for subjects with known diabetes

Exclusion Criteria:

• Untreated or symptomatic central nervous system (CNS) metastases
• Prior anti-cancer therapy as follows: Any prior chemotherapy for squamous NSCLC; Any prior adjuvant or neoadjuvant chemotherapy for squamous NSCLC; Any prior chemoradiation for squamous NSCLC; Central (chest) radiation therapy ≤ 28 days prior to enrollment, radiation therapy for peripheral lesions≤14 days prior to enrollment for squamous NSCLC

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1 Cohort 1; AMG 479 at 18 mg/kg in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 at 18 mg/kg monotherapy for 24 months from study day 1	Biological: AMG 479; AMG 479 at 12 mg/kg IV in combination with chemotherapy Day 1 of cycle 1 to 6 (except for subjects being evaluated by intensive PK who will be administered AMG 479 on day 2 of cycle 1 and then day 1 of every cycle thereafter) followed by AMG 479 at 12 mg/kg IV monotherapy for up to 24 months from study day 1; Biological: AMG 479; AMG 479 at 18mg/kg IV in combination with chemotherapy Day 1 of cycle 1 to 6 (except for subjects being evaluated by intensive PK who will be administered AMG 479 on Day 2 of cycle 1 and then day 1 of every cycle thereafter) followed by AMG 479 at 18 mg/kg IV monotherapy for up to 24 months from day 1; Drug: Carboplatin; Carboplatin (AUC 6) IV infusion over 30 (± 10) minutes according to institutional guidelines Day 1 of Cycle 1 to 6; Biological: AMG 479; AMG 479 IV in combination with chemotherapy on day 1 of every 3 week cycle for 4 to 6 cycles, followed by AMG 479 IV monotherapy for up to 24 months from study day 1. The AMG 479 dose to be used will be the final AMG 479 dose explored from Part 1; Drug: Paclitaxel; Paclitaxel at 200 mg/m2 IV infusion over 3 hours (± 30 minutes) according to institutional guidelines Day 1 of Cycle 1 to 6
Experimental: Part 1 Cohort 2; AMG 479 at 12 mg/kg in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 at 12 mg/kg monotherapy for 24 months from study day 1	Biological: AMG 479; AMG 479 at 12 mg/kg IV in combination with chemotherapy Day 1 of cycle 1 to 6 (except for subjects being evaluated by intensive PK who will be administered AMG 479 on day 2 of cycle 1 and then day 1 of every cycle thereafter) followed by AMG 479 at 12 mg/kg IV monotherapy for up to 24 months from study day 1; Biological: AMG 479; AMG 479 at 18mg/kg IV in combination with chemotherapy Day 1 of cycle 1 to 6 (except for subjects being evaluated by intensive PK who will be administered AMG 479 on Day 2 of cycle 1 and then day 1 of every cycle thereafter) followed by AMG 479 at 18 mg/kg IV monotherapy for up to 24 months from day 1; Drug: Carboplatin; Carboplatin (AUC 6) IV infusion over 30 (± 10) minutes according to institutional guidelines Day 1 of Cycle 1 to 6; Biological: AMG 479; AMG 479 IV in combination with chemotherapy on day 1 of every 3 week cycle for 4 to 6 cycles, followed by AMG 479 IV monotherapy for up to 24 months from study day 1. The AMG 479 dose to be used will be the final AMG 479 dose explored from Part 1; Drug: Paclitaxel; Paclitaxel at 200 mg/m2 IV infusion over 3 hours (± 30 minutes) according to institutional guidelines Day 1 of Cycle 1 to 6
Experimental: Part 2; AMG 479 in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 monotherapy for 24 months from study day 1 (AMG 479 dose in Part 2 will be the final AMG 479 dose from Part 1)	Biological: AMG 479; AMG 479 at 12 mg/kg IV in combination with chemotherapy Day 1 of cycle 1 to 6 (except for subjects being evaluated by intensive PK who will be administered AMG 479 on day 2 of cycle 1 and then day 1 of every cycle thereafter) followed by AMG 479 at 12 mg/kg IV monotherapy for up to 24 months from study day 1; Biological: AMG 479; AMG 479 at 18mg/kg IV in combination with chemotherapy Day 1 of cycle 1 to 6 (except for subjects being evaluated by intensive PK who will be administered AMG 479 on Day 2 of cycle 1 and then day 1 of every cycle thereafter) followed by AMG 479 at 18 mg/kg IV monotherapy for up to 24 months from day 1; Drug: Carboplatin; Carboplatin (AUC 6) IV infusion over 30 (± 10) minutes according to institutional guidelines Day 1 of Cycle 1 to 6; Biological: AMG 479; AMG 479 IV in combination with chemotherapy on day 1 of every 3 week cycle for 4 to 6 cycles, followed by AMG 479 IV monotherapy for up to 24 months from study day 1. The AMG 479 dose to be used will be the final AMG 479 dose explored from Part 1; Drug: Paclitaxel; Paclitaxel at 200 mg/m2 IV infusion over 3 hours (± 30 minutes) according to institutional guidelines Day 1 of Cycle 1 to 6

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Part 1: The incidence of adverse events and clinical laboratory abnormalities defined as dose limiting toxicities	Part 1 Only
Part 2: Objective Response Rate as per modified RECIST criteria by investigator review	Length of Study

Secondary Outcome Measures

Outcome Measure	Time Frame
Part 1: The incidence of adverse events and laboratory abnormalities not defined as Dose Limiting Toxicities	Length of Study
Part 1: Incidence of anti-AMG 479 antibody formation	Length of Study
Part 2: Progression Free Survival, Time to Progression, Duration of Response, 1 & 2 year survival rates, and Overall Survival including subjects who received the final dose in Part 1	Length of Study
Part 2 Incidence of adverse events and laboratory abnormalities	Length of Study
Incidence of anti-AMG479 antibody formation	Length of Study

Collaborators and Investigators

• Sponsor: NantCell, Inc.

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: December 11, 2008
• First Submitted That Met QC Criteria: December 11, 2008
• First Posted (Estimate): December 12, 2008

Study Record Updates

• Last Update Posted (Actual): March 29, 2017
• Last Update Submitted That Met QC Criteria: March 27, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Monoclonal Antibody; AMG 479; Apoptosis; IGF-1R; Advanced Squamous Non-Small Cell Lung Cancer; antibody 1st-line
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Carboplatin; Paclitaxel; Antibodies, Monoclonal
• Other Study ID Numbers: 20080257; QUILT-2.017 (Other Identifier: NantCell, Inc.)