BATTLE-2 Program: A Biomarker-Integrated Targeted Therapy Study in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01248247
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Erlotinib — DRUG
    150 mg by mouth each day of a 28 day cycle.
  • AZD6244 — DRUG
    100 mg by mouth daily of a 28 day cycle.
  • MK-2206 — DRUG
    100 mg by mouth every week of a 28 day cycle.
  • Sorafenib — DRUG
    400 mg by mouth twice a day for a 28 day cycle.
  • Erlotinib — DRUG
    150 mg by mouth daily of a 28 day cycle.
  • MK-2206 — DRUG
    135 mg by mouth every week of a 28 day cycle.

Study Details

Different people have different biomarkers (chemical "markers" in the blood that may be related to your reaction to study drugs). If researchers know about your biomarkers before you receive treatment, they may be able to prescribe a treatment that is better suited to your body's specific needs. The goal of this clinical research study is to learn if drug or drug combinations based on your biomarkers can help to control NSCLC. The safety of these drug combinations will also be studied.

Key Dates

First listed
Nov 25, 2010
Start date
Jun 2, 2011
Status verified
Dec 2021
Primary completion
Nov 30, 2020
Completion
Nov 30, 2020

Study Design

Enrollment
334 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1 - Erlotinib
    Erlotinib 150 mg by mouth each day of a 28 day cycle.
  • Experimental: Group 2 - Erlotinib + MK-2206
    Erlotinib 150 mg by mouth each day of a 28 day cycle. MK-2206 135 mg by mouth every week of a 28 day cycle.
  • Experimental: Group 3 - AZD6244 + MK-2206
    AZD6244 100 mg by mouth daily of a 28 day cycle. MK-2206 100 mg by mouth every week of a 28 day cycle.
  • Experimental: Group 4 - Sorafenib
    Sorafenib 400 mg by mouth twice a day for a 28 day cycle.

Primary Outcome Measure

8-Week Disease Control Rate (DCR) [ Time Frame: 8 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Yale UniverstiyNew HavenConnecticut06520-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in New Haven, CT

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Yale Universtiy· New Haven, CTUniversity of Texas MD Anderson Cancer Center· Houston, TX

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