Study of Erlotinib With or Without Investigational Drug (U3-1287) in Subjects With Advanced Non-small Cell Lung Cancer

Part of paid clinical trials in Glendale, Arizona.

Sponsor
Daiichi Sankyo
Study ID
NCT01211483
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • NSCLC (Advanced Non-small Cell Lung Cancer)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • U3-1287 — DRUG
    Liquid 70 mg/mL for IV infusion at high dose or low dose
  • Erlotinib — DRUG
    Tablet 150 mg for oral administration
  • Placebo — DRUG
    Placebo liquid matching U3-1287 for IV infusion

Study Details

This is a Phase 1b/2 study. In Phase 1b, subjects will know the treatment they are receiving. Subjects will receive Erlotinib + U3-1287. The Phase 1b portion will determine if adding U3-1287 to Erlotinib will be safe in subjects with advanced non-small cell lung cancer who fail prior treatment. In the Phase 2 portion, subjects will be blinded to the treatments they are receiving. Subjects will receive either Erlotinib alone or Erlotinib + U3-1287. The Phase 2 portion will determine if adding U3-1287 to Erlotinib will be safe and improve survival in subjects with advanced non-small cell lung cancer who failed the first treatment.

Key Dates

First listed
Sep 29, 2010
Start date
Sep 30, 2010
Status verified
May 2021
Primary completion
Oct 31, 2013
Completion
Nov 23, 2013

Study Design

Enrollment
222 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: U3-1287 (high dose) + Erlotinib
    U3-1287 (high dose) intravenously (IV) every three weeks (Q3W) + Erlotinib 150 mg/day orally (PO) until cancer gets worse, side effects become unacceptable or participant withdraws consent
  • Experimental: Part B: U3-1287 (low dose) + Erlotinib
    U3-1287 (low dose) IV Q3W + Erlotinib 150 mg/day PO until cancer gets worse, side effects become unacceptable or participant withdraws consent
  • Placebo Comparator: Part B: Placebo + Erlotinib
    Placebo matching U3-1287 IV Q3W + Erlotinib150 mg/day PO until cancer gets worse, side effects become unacceptable or participant withdraws consent

Primary Outcome Measure

Progression-Free Survival Following U3-1287 (AMG 888) in Combination With Erlotinib [ Time Frame: Time from the randomization date up to the date of first objective documentation of disease progression or death due to any cause (whichever comes first), up to 3 years 2 months ]

Locations (14)

FacilityCityStateZIPSite coordinators
-GlendaleArizona--
TRM - Oncology Research Associates, PLLC, d/b/a Pinnacle Oncology HematologyScottsdaleArizona85258-
-AnaheimCalifornia--
-EncinitasCalifornia--
-La VerneCalifornia--
-Los AngelesCalifornia--
-OrlandoFlorida--
-AtlantaGeorgia--
-JolietIllinois--
-EvansvilleIndiana--
-Baton RougeLouisiana--
-DetroitMichigan--
-The BronxNew York--
-YorkPennsylvania--

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By research site
TRM - Oncology Research Associates, PLLC, d/b/a Pinnacle Oncology Hematology· Scottsdale, AZ

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