Clinical trial NCT02392507: A Study of Nab-Paclitaxel and Carboplatin Plus Necitumumab (LY3012211) in Participants With Stage IV Squamous NSCLC
Official title: A Single-Arm, Multicenter, Open-Label, Phase 2 Study of Nab®-Paclitaxel (Abraxane®) and Carboplatin Chemotherapy Plus Necitumumab (LY3012211) in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small Cell Lung Cancer (NSCLC)
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Celgene
First posted: 2015-03-19
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine if nab-paclitaxel and carboplatin chemotherapy plus necitumumab is effective and safe in participants with stage IV squamous non-small cell lung cancer.


Eligibility criteria: Inclusion Criteria:

* Have histologically or cytologically confirmed squamous NSCLC.
* Have stage IV disease at the time of study entry (American Joint Committee on Cancer \[AJCC\] Staging Manual, 7th edition).
* Have measurable disease at the time of study enrollment as defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).
* Have tumor tissue available for biomarker analysis.
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
* Have adequate organ functions.

Exclusion Criteria:

* Are currently enrolled in another clinical trial.
* Have received prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the epidermal growth factor receptor (EGFR), vascular endothelial growth factor (VEGF), or VEGF receptor.
* Have received previous chemotherapy for advanced NSCLC. Participants who have received adjuvant or neoadjuvant chemotherapy are eligible if the last administration of the prior regimens occurred at least 1 year prior to study entry.
* Have undergone major surgery or received any investigational therapy in the 4 weeks prior to study entry.
* Have undergone systemic radiotherapy within 4 weeks prior to study entry, or focal radiotherapy within 2 weeks prior to study entry.
* Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not required).
* Have a history of arterial or venous embolism within 6 months prior to study entry.
* Have clinical evidence of concomitant infectious conditions.
* Have a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of necitumumab, or any other contraindication to one of the administered treatments.
* Are pregnant or breastfeeding.
* Have a known history of drug abuse.
* Have a concurrent active malignancy. Participants with a history of malignancy are eligible provided the participant has been disease-free for ≥3 years, with the following exception: Participants with adequately treated basal or squamous cell carcinoma of the skin, preinvasive carcinoma of the cervix, or any cancer that in the judgment of the investigator and Lilly clinical research physician/designee may not affect the interpretation of results (for example, prostate, bladder) are eligible.
* Have discontinued investigational product or non approved use of a drug or device from a clinical trial within 30 days before the first day of study treatment.

Primary outcomes:
measure: Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response or Partial Response (Objective Tumor Response Rate [ORR])
timeFrame: From Date of Randomization to Objective Disease Progression (Up to 18 Months)
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: From Date of Randomization to Measured Progressive Disease or Death Due to Any Cause (Up to 18 Months)
measure: Overall Survival (OS)
timeFrame: From Date of Randomization until Death Due to Any Cause (Up to 18 Months)
measure: Percentage of Participants Who Achieve Best Overall Disease Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])
timeFrame: From Date of Randomization to Objective Disease Progression or Start of New Anticancer Therapy (Up to 18 Months)
measure: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab, Nab-Paclitaxel, and Carboplatin
timeFrame: Cycle 3 and cycle 4: predose
measure: PK: Maximum Concentration (Cmax) of Necitumumab, Nab-Paclitaxel, and Carboplatin
timeFrame: Cycle 1, 3 and 4: predose and <15minutes (min) post end-of-infusion
measure: Immunogenicity: Number of Participants Developing Anti-drug Antibodies to Necitumumab
timeFrame: Predose Cycle 1 Through Short Term Follow Up (Up To 18 Months)
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Florida Hospital Cancer Institute
state: Florida
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: