Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Necitumumab

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

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.

Nab-Paclitaxel

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)

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.

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)

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.

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.

PFS defined as time from date of randomization until first radiographic documentation of measured PD defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. PD was at least 20% increase in sum of diameters of target lesions with reference being 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.If participant does not have complete baseline disease assessment,PFS time censored at date of randomization,regardless of whether or not objectively determined disease progression or death observed for participant.If participant was not known to have died or have objective progression as of data inclusion cutoff date for analysis,the PFS time censored at last adequate tumor assessment date.The use of new anticancer therapy prior to occurrence of PD resulted in censoring at the date of last radiographic assessment prior to initiation of new therapy.

OS defined as the time from the date of randomization to the date of death due to any cause. Participants who are alive at the time of study completion or are lost to follow-up will be censored at the time they were last known to be alive.

Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. 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.

The Cmin is the minimum observed serum/plasma concentration of Necitumumab, Nab-Paclitaxel, and Carboplatin.

The Cmax is the maximum observed serum/plasma concentration of Necitumumab, Nab-Paclitaxel, and Carboplatin.

A participant was considered to have an anti-drug antibody response if anti-drug antibodies (ADA) were detected at any time point.

Celgene

Eli Lilly and Company

All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.

Necitumumab administered IV at 800 mg on day 1 and 8 of each cycle (3 week cycles); nab-paclitaxel administered IV at 100 mg/m² on day 1, 8 and 15 of each cycle; carboplatin administered IV at a concentration of AUC 6 mg\*min/mL on day 1 of each cycle, for a maximum of 4 cycles. Participants may continue to receive treatment until discontinuation criteria are met.

Necitumumab + Nab-paclitaxel + Carboplatin: Induction Phase

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.

Necitumumab + Nab-paclitaxel: Maintenance Phase

Induction: Necitumumab administered IV at 800 mg on day 1 and 8 of each cycle (3 week cycles); nab-paclitaxel administered IV at 100 mg/m² on day 1, 8 and 15 of each cycle; carboplatin administered IV at a concentration of AUC 6 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.

Necitumumab + Nab-Paclitaxel + Carboplatin

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Germany

Spain

Greece

Region of Enrollment

All randomized participants who received at least 1 dose of study drug.

Chief Medical Officer

All randomized participants who received at least 1 dose of study drug and who had a complete radiographic assessment at baseline and at least 1 complete radiographic assessment post-baseline.

Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response or Partial Response (Objective Tumor Response Rate [ORR])

All randomized participants who received at least 1 dose of study drug. Censored participants = 15.

Progression Free Survival (PFS)

All randomized participants who received at least 1 dose of study drug. Censored participants = 35.

Overall Survival (OS)

All randomized participants who received at least 1 dose of study drug and who had a complete radiographic assessment at baseline.

Percentage of Participants Who Achieve Best Overall Disease Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])

Cycle 3

Cycle 4

Necitumumab administered IV at 800 mg on day 1 and 8 of each cycle (3 week cycles).

Carboplatin administered IV at a concentration of AUC 6 mg\*min/mL on day 1 of each cycle, for a maximum of 4 cycles.

Nab-paclitaxel administered IV at 100 mg/m² on day 1, 8 and 15 of each cycle.

All randomized participants who received at least 1 dose of study drug and had evaluable PK data.

Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab, Nab-Paclitaxel, and Carboplatin

Cycle 1

Necitumumab administered IV 800 mg on day 1 and 8 of each cycle (3 week cycles).

PK: Maximum Concentration (Cmax) of Necitumumab, Nab-Paclitaxel, and Carboplatin

All randomized participants who received at least 1 dose of study drug and had evaluable data for antibodies.

Spots Global Cancer Trial Database for A Study of Nab-Paclitaxel and Carboplatin Plus Necitumumab (LY3012211) in Participants With Stage IV Squamous NSCLC

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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