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An Open-Label, Multicenter, Phase 1b/2 Study to Evaluate Necitumumab in Combination With Gemcitabine and Cisplatin in the First-Line Treatment of Patients With Advanced (Stage IV) Squamous Non-Small Cell Lung Cancer (NSCLC)


Phase 1/Phase 2
20 Years
N/A
Open (Enrolling)
Both
Squamous Non-small Cell Lung Cancer

Thank you

Trial Information

An Open-Label, Multicenter, Phase 1b/2 Study to Evaluate Necitumumab in Combination With Gemcitabine and Cisplatin in the First-Line Treatment of Patients With Advanced (Stage IV) Squamous Non-Small Cell Lung Cancer (NSCLC)


Inclusion Criteria:



- Squamous Non-Small Cell Lung Cancer Disease

- Clinical Stage IV

- Measurable or nonmeasurable disease as defined by Response Evaluation Criteria in
Solid Tumors (RECIST) version 1.1

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1

- No prior chemotherapy regimen, surgery and chest radiotherapy

- Adequate organ function

- Estimated life expectancy of at least 12 weeks

Exclusion Criteria:

- Has undergone major surgery within 28 days prior to enrollment or have planned major
surgery, subcutaneous venous access device placement within 7 days prior to
enrollment

- Has undergone any prior radiation therapy, except for Gamma Knife radiation and
palliative radiation treatment at least 14 days have elapsed from last radiation
treatment prior to enrollment

- Has brain metastases that are symptomatic or require surgery, medication and
radiotherapy except Gamma Knife

- Has superior vena cava syndrome

- Has clinically relevant coronary artery disease or uncontrolled congestive - heart
failure

- Has uncontrolled hypertension

- Has diabetes requiring insulin

- Has an angina or has experienced myocardial infarction within 6 months prior to
enrollment

- Has an Acquired Immunodeficiency Syndrome (AIDS)-related illness

- Has evidence of or test positive test results for hepatitis B, or hepatitis C virus
antibodies

- Has a known allergy and history of hypersensitivity reaction

- Has significant third-space fluid retention

- Has history of interstitial pneumonitis

- Has an ongoing or active infection

- Has a history of significant neurological or psychiatric disorders

- Has a Grade 2 peripheral neuropathy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase 1b: Number of Participants with Dose Limiting Toxicities (DLTs)

Outcome Time Frame:

Day 1 to Day 21 in Cycle 1 (estimated up to 21 days)

Safety Issue:

Yes

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

14461

NCT ID:

NCT01763788

Start Date:

May 2013

Completion Date:

March 2017

Related Keywords:

  • Squamous Non-small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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