A Study of Necitumumab and Chemotherapy in Participants With Stage IV Squamous Non-Small Cell Lung Cancer
|Squamous Non Small Cell Lung Cancer||Drug: Necitumumab Drug: Paclitaxel Drug: Carboplatin||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Randomized, Multicenter, Open-Label, Phase 2 Study of Paclitaxel-Carboplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Paclitaxel-Carboplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)|
- Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR]) [ Time Frame: Baseline to Disease Progression or Death (Up to 24 Months) ]The denominator of ORR (Objective Response Rate) includes each participant enrolled who received any amount of study drug (necitumumab, gemcitabine, and/or cisplatin), and who had a complete radiographic assessment at baseline and at least one complete radiographic assessment post-baseline. The numerator includes those participants counted in the denominator with a confirmed best overall tumor response of partial or complete response (Complete Response (CR): disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter.) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Overall Survival (OS) [ Time Frame: Randomization to Date of Death (Up to 24 Months) ]OS defined as the time from the date of randomization to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS was censored at the last contact date (last contact for participants in post-discontinuation = last known alive date in mortality status).
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Necitumumab [ Time Frame: Pre-infusion Cycle 1, Day 1; Cycle 3, Day 1; Cycle 5; Day 1 (within 2 hours prior to beginning of infusion) ]
- Percentage of Participants With Anti Necitumumab Antibodies [ Time Frame: Baseline to End of Cycle 6 ]
- Progression-Free Survival [ Time Frame: Randomization to Progressive Disease or Death (Up to 24 Months) ]Progression-Free Survival (PFS) is defined as the time from randomization until the first radiographically documented progressive disease (PD) or death from any cause. PD defined by Response Evaluation Criteria in Solid Tumors Criteria (RECIST version 1.1) as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. For participants not known to have died as of the data cut-off date and who do not have objective PD, PFS will be censored at the date of the last complete radiographic assessment.
- Percentage of Participants Who Achieve Best Overall Disease Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR]) [ Time Frame: Baseline to Progressive Disease and/or Death (Estimated up to 24 Months) ]Defined using the same denominator as defined in ORR. Among participants counted in the denominator, the numerator counts those with a confirmed best tumor response of SD, PR, or CR per RECIST 1.1. (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PR at least 30% decrease in the sum of diameter of target lesions; CR: disappearance of all target lesions).
- Percent Change in Tumor Size (CTS) [ Time Frame: Baseline to Progressive Disease or Death (Up to 24 Months) ]CTS is defined as maximum percent change from baseline in the sum of target lesions.
- Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab [ Time Frame: Cycle 1, Day 8 ; Cycle 2, Day 1; Cycle 3, Day 1;Cycle 4, Day1;Cycle 5, Day 1; Cycle 6, Day 1 (within 2 hours prior to beginning of infusion) ]
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||December 2017|
|Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Experimental: Necitumumab +Paclitaxel+Carboplatin
Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.
Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.
Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle.
The combination of paclitaxel-carboplatin and necitumumab may continue for a maximum of 6 cycles. Necitumumab may continue until Progressive Disease (PD), toxicity requiring cessation, protocol noncompliance, or withdrawal of consent.
Other Names:Drug: Paclitaxel
Administered IVDrug: Carboplatin
Active Comparator: Paclitaxel + Carboplatin
Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC=6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles. After completion of chemotherapy, participants will be followed until radiographic documentation of PD.
Administered IVDrug: Carboplatin
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769391
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|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|