Status:

TERMINATED

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

Lead Sponsor:

NantCell, Inc.

Conditions:

Advanced Squamous Non-Small Cell Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

Brief Summary

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 f...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2010

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT00807612

Start Date

January 1 2009

End Date

August 1 2010

Last Update

September 25 2024

Active Locations (25)

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Page 1 of 7 (25 locations)

1

Research Site

Fayetteville, Arkansas, United States, 72703

2

Research Site

Fayetteville, Arkansas, United States

3

Research Site

Fort Wayne, Indiana, United States, 46845

4

Research Site

Fort Wayne, Indiana, United States