A Study of Nab-Paclitaxel and Carboplatin Plus Necitumumab (LY3012211) in Participants With Stage IV Squamous NSCLC
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)
2 other identifiers
interventional
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2015
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2015
CompletedFirst Posted
Study publicly available on registry
March 19, 2015
CompletedStudy Start
First participant enrolled
October 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 29, 2018
CompletedResults Posted
Study results publicly available
February 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 6, 2019
CompletedNovember 19, 2020
November 15, 2019
2.3 years
March 16, 2015
January 18, 2019
October 30, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response or Partial Response (Objective Tumor Response Rate [ORR])
ORR was the percentage of participants achieving a best overall response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of nontarget lesions, and no appearance of new lesions. Progressive disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
From Date of Randomization to Objective Disease Progression (Up to 18 Months)
Secondary Outcomes (6)
Progression Free Survival (PFS)
From Date of Randomization to Measured Progressive Disease or Death Due to Any Cause (Up to 18 Months)
Overall Survival (OS)
From Date of Randomization until Death Due to Any Cause (Up to 18 Months)
Percentage of Participants Who Achieve Best Overall Disease Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])
From Date of Randomization to Objective Disease Progression or Start of New Anticancer Therapy (Up to 18 Months)
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab, Nab-Paclitaxel, and Carboplatin
Cycle 3 and cycle 4: predose
PK: Maximum Concentration (Cmax) of Necitumumab, Nab-Paclitaxel, and Carboplatin
Cycle 1, 3 and 4: predose and <15minutes (min) post end-of-infusion
- +1 more secondary outcomes
Study Arms (1)
Necitumumab + Nab-Paclitaxel + Carboplatin
EXPERIMENTALInduction: Necitumumab administered intravenously (IV) at 800 milligram (mg) on day 1 and 8 of each cycle (3 week cycles); nab-paclitaxel administered IV at 100 milligram per square meter (mg/m²) on day 1, 8 and 15 of each cycle; carboplatin administered IV at a concentration of AUC (area under curve) 6 milligram per milliliter over time (mg\*min/mL) on day 1 of each cycle, for a maximum of 4 cycles. Maintenance: Necitumumab administered IV at 800 mg on day 1 and 8 of each cycle; nab-paclitaxel administered IV at 100mg/m² on day 1 and 8 of each cycle (3 week cycles). Participants may continue to receive treatment until discontinuation criteria are met.
Interventions
Administered IV
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- Celgenecollaborator
Study Sites (1)
Florida Hospital Cancer Institute
Orlando, Florida, 32804, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2015
First Posted
March 19, 2015
Study Start
October 12, 2015
Primary Completion
January 29, 2018
Study Completion
November 6, 2019
Last Updated
November 19, 2020
Results First Posted
February 12, 2019
Record last verified: 2019-11-15
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.