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)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response or Partial Response (Objective Tumor Response Rate [ORR])
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
Necitumumab + Nab-Paclitaxel + Carboplatin
Induction: 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.
Intervention: Necitumumab (Drug)
Necitumumab + Nab-Paclitaxel + Carboplatin
Induction: 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.
Intervention: Nab-Paclitaxel (Drug)
Necitumumab + Nab-Paclitaxel + Carboplatin
Induction: 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.
Intervention: Carboplatin (Drug)
Outcomes
Primary Outcomes
Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response or Partial Response (Objective Tumor Response Rate [ORR])
Time Frame: From Date of Randomization to Objective Disease Progression (Up to 18 Months)
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.
Secondary Outcomes
- 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))
- Immunogenicity: Number of Participants Developing Anti-drug Antibodies to Necitumumab(Predose Cycle 1 Through Short Term Follow Up (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)