Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Carboplatin

Antibodies

Antibodies, Monoclonal

Cetuximab

Cisplatin

Immunoglobulins

Antimetabolites

Antineoplastic Agents, Immunological

Immunologic Factors

Cycles repeat every 3 weeks for first 6 cycles (18 weeks) and then once every 2 weeks (maintenance therapy) until disease progression, intolerable toxicity, withdrawal of consent or other withdrawal criteria met

\*Cisplatin will replace Carboplatin. Gemcitabine/Carboplatin/Cetuximab (GCC) plus cixutumumab will change to Gemcitabine/Cisplatin/Cetuximab (GCiC) plus cixutumumab (participants enrolled subsequent to this change will receive gemcitabine, cisplatin and cetuximab, plus cixutumumab)

Cycles repeat every 3 weeks for 6 cycles (18 weeks) and then once every 2 weeks (maintenance therapy) until disease progression, intolerable toxicity, withdrawal of consent or other withdrawal criteria met

\*Cisplatin will replace Carboplatin. GCC plus cixutumumab will change to GCiC plus cixutumumab (participants enrolled subsequent to this change will receive gemcitabine, cisplatin and cetuximab, plus cixutumumab)

1000 milligrams per square meter (mg/m\^2) on Days 1 and 8 of each cycle

\[First 6 cycles (18 weeks)\]

75 mg/m\^2 on Day 1 of each cycle

\[First 6 cycles (18 weeks)\]

6 milligrams per kilogram (mg/kg) intravenous (IV) infusion, administered once per week (on Days 1, 8, and 15 of each cycle)

\[First 6 cycles (18 weeks)\]

IMC-A12 (cixutumumab)

400 mg/m\^2 IV infusion, administered on Day 1 of Cycle 1, 250 mg/m\^2 once per week thereafter

\[First 6 cycles (18 weeks)\]

10 mg/kg IV infusion, administered once every 2 weeks

(Maintenance therapy)

500 mg/m\^2 IV infusion, administered once every 2 weeks

(Maintenance therapy)

Area under the curve (AUC) = 5, Day 1 of each cycle

\[First 6 cycles (18 weeks)\]

\*Carboplatin will be replaced by Cisplatin

E-mail: ClinicalTrials@ ImClone.com

The purpose of this study is to determine the number of participants whose cancer shrinks or disappears after treatment on the study.

Participants with Stage IIIb or IV non-small cell lung cancer (NSCLC) who have not received previous chemotherapy will be stratified, based on disease histology (squamous versus \[vs.\] nonsquamous).

A Study of IMC-A12 (Cixutumumab) With and Without Other Standard Chemotherapies in Participants With Lung Cancer Who Have Not Received Chemotherapy Before

Randomized, Open Label, Stratified Phase 2 Trial of Gemcitabine, Carboplatin, and Cetuximab With Vs. Without IMC-A12 in Chemotherapy-Naive Patients With Advanced/Metastatic Non-Small Cell Lung Cancer

ORR was defined as the percentage of participants achieving either CR or PR. Response was defined using Response Evaluation Criteria in Solid Tumors (RECIST), version (v) 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions and the normalization of the tumour marker level. PR was defined as having at least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Percentage of participants is calculated as a total number of participants with CR or PR / total number of participants treated \* 100.

OS was defined as the duration from the date of randomization to the date of death from any cause. For participants who were alive, OS was censored at the date of last follow-up visit or at the date of last contact.

PFS was defined as the duration from the date of randomization until disease progression or death due to any cause, whichever occurred first. Response was defined using RECIST, v 1.0 criteria. PD was defined as having a ≥20% increase in sum of LD of target lesions or the appearance of new lesions and/or unequivocal progression of non-target lesions. For participants who were alive and without disease progression, PFS was censored at the date of last objective tumor assessment. For participants who did not experience disease progression and were lost to follow-up, PFS was censored at the date of the last objective tumor assessment or the date of last contact.

TTP was defined as the duration from the date of randomization until the date of disease progression. Response was defined using RECIST v 1.0 criteria. PD was defined as having a ≥20% increase in the sum of LD of target lesions or the appearance of new lesions and/or unequivocal progression of non-target lesions. For participants without disease progression, TTP was censored at the date of last objective tumor assessment. For participants without disease progression and were subsequently lost to follow-up, TTP was censored at the date of last follow-up visit or at the date of last contact.

The duration of CR or PR was defined as the time from first objective status assessment of CR or PR to the first time of disease progression or death. Response was defined using RECIST v 1.0 criteria. CR was defined as the disappearance of all target lesions and non-target lesions. PR was defined as having at least a 30% decrease in sum of LD of target lesions. Duration of response was censored on the date of last tumor assessment for participants who were alive and have no evidence of disease progression.

Data presented are the number of participants who experienced 1 or more AEs, serious AEs (SAEs), and AEs that lead to death during the study including the 30-day follow-up. A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this report.

Eli Lilly and Company

Gemcitabine: 1000 mg/m\^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).

Cetuximab: Initial dose of 400 mg/m\^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m\^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m\^2 Q2W in the subsequent cycles (2-week cycles).

Carboplatin: AUC = 5 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).

Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met.

Gemcitabine/Carboplatin/Cetuximab (GCC)

Gemcitabine: 1000 mg/m\^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).

Cetuximab: Initial dose of 400 mg/m\^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m\^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m\^2 Q2W in the subsequent cycles (2-week cycles).

Carboplatin: AUC = 5 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).

Cixutumumab: 6 mg/kg IV infusion Q1W on Days 1, 8, and 15 of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 10 mg/kg IV Q2W in the subsequent cycles (2-week cycles).

Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met.

GCC Plus Cixutumumab

Gemcitabine: 1000 mg/m\^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).

Cisplatin: 75 mg/m\^2 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).

Cetuximab: Initial dose of 400 mg/m\^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m\^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m\^2 Q2W in the subsequent cycles (2-week cycles).

Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met.

Gemcitabine/Cisplatin/Cetuximab (GCiC)

Gemcitabine: 1000 mg/m\^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).

Cisplatin: 75 mg/m\^2 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).

Cetuximab: Initial dose of 400 mg/m\^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m\^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m\^2 Q2W in the subsequent cycles (2-week cycles).

Cixutumumab: 6 mg/kg IV infusion Q1W on Days 1, 8, and 15 of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 10 mg/kg IV Q2W in the subsequent cycles (2-week cycles).

Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met.

GCiC Plus Cixutumumab

Gemcitabine: 1000 mg/m\^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).

Cisplatin: 75 mg/m\^2 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).

Cetuximab: Initial dose of 400 mg/m\^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m\^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m\^2 Q2W in the subsequent cycles (2-week cycle).

Cixutumumab: 6 mg/kg IV infusion Q1W on Days 1, 8, and 15 of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 10 mg/kg IV Q2W in the subsequent cycles (2-week cycles).

Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race/Ethnicity, Customized

United States

Region of Enrollment

Height

Weight

BSA is the measured or calculated surface area of a human body based on body weight and height.

Body Surface Area (BSA)

ECOG performance status was used to classify participants according to their functional impairment. Score 0 = fully active, able to carry on all pre-disease performance without restriction. Score 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, for example, light house work, office work.

Eastern Cooperative Oncology Status Performance Status (ECOG PS) Score

Randomization Stratum

Chief Medical Officer

All participants randomized to GCiC and GCiC Plus Cixutumumab arms. Efficacy data were not summarized for the original treatment arms (GCC and GCC Plus Cixutumumab) since such summaries were not considered relevant to the study objectives under the amended protocol.

Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]

GCiC

All participants randomized to GCiC and GCiC Plus Cixutumumab arms. Participants censored: GCiC = 6, GCiC Plus cixutumumab = 6. Efficacy data were not summarized for the original treatment arms (GCC and GCC Plus Cixutumumab) since such summaries were not considered relevant to the study objectives under the amended protocol.

Overall Survival (OS)

All participants randomized to GCiC and GCiC Plus Cixutumumab arms. Participants censored: GCiC = 2, GCiC Plus cixutumumab = 10. Efficacy data were not summarized for the original treatment arms (GCC and GCC Plus Cixutumumab) since such summaries were not considered relevant to the study objectives under the amended protocol.

Progression-Free Survival (PFS)

All participants (pts) randomized to GCiC and GCiC Plus Cixutumumab arms. Participants censored: GCiC = 9, GCiC Plus Cixutumumab = 12. Efficacy data were not summarized for the original treatment arms (GCC and GCC Plus Cixutumumab) since such summaries were not considered relevant to the study objectives under the amended protocol.

Time To Progression (TTP)

All pts randomized to GCiC and GCiC Plus Cixutumumab arms and who had CR or PR, except 1 pt in GCiC group eliminated d/t PR after starting additional treatment. Participants censored: GCiC = 0, GCiC Plus Cixutumumab = 1. Efficacy data were not summarized for the original treatment arms (GCC and GCC Plus Cixutumumab) due to the amended protocol.

Duration of Response

SAEs

Deaths Due to AEs

Number of Participants With Adverse Events (AEs) or Deaths

Zero participants analyzed. Analysis was not performed due to lack of an appropriate validated assay.

Serum Anti-Cixutumumab Antibody Assessment (Immunogenicity)

Zero participants analyzed. No PK samples analyzed due to being expired prior to assay developed to analyze.

Maximum Concentration (Cmax) of Cixutumumab at Study Day 1

Cmax of Cixutumumab for Cycle 1

Cmax of Cixutumumab for Cycle 3

Cmax of Cixutumumab Cycle 5

Minimum Concentration (Cmin) of Cixutumumab at Study Day 1

Cmin of Cixutumumab for Cycle 1

Cmin of Cixutumumab for Cycle 3

Gemcitabine: 1000 mg/m\^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).

Cisplatin: 75 mg/m\^2 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).

Cetuximab: Initial dose of 400 mg/m\^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m\^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m\^2 Q2W in the subsequent cycles (2-week cycle).

Cixutumumab: 6 mg/kg IV infusion Q1W on Days 1, 8, and 15 of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 10 mg/kg Q2W in the subsequent cycles (2-week cycle).

Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met.

Cmin of Cixutumumab for Cycle 5

Gemcitabine: 1000 milligrams per square meter (mg/m\^2) on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).

Cetuximab: Initial dose of 400 mg/m\^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m\^2 once every week (Q1W) of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m\^2 once every 2 weeks (Q2W) in the subsequent cycles (2-week cycles).

Carboplatin: Area under the curve (AUC) = 5 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).

Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met.

Gemcitabine: 1000 mg/m\^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).

Cetuximab: Initial dose of 400 mg/m\^2 on Day 1 of Cycle 1 and subsequent doses of 250 mg/m\^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m\^2 Q2W in the subsequent cycles (2-week cycles).

Carboplatin: AUC = 5 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).

Cixutumumab: 6 milligrams per kilogram (mg/kg) intravenous (IV) infusion Q1W on Days 1, 8, and 15 of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 10 mg/kg IV Q2W in the subsequent cycles (2-week cycles).

Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met.

Gemcitabine: 1000 mg/m\^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).

Cisplatin: 75 mg/m\^2 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).

Cetuximab: Initial dose of 400 mg/m\^2 on Day 1 of Cycle 1 and subsequent doses of 250 mg/m\^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m\^2 Q2W in the subsequent cycles (2-week cycles).

Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met.

Gemcitabine: 1000 mg/m\^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).

Cisplatin: 75 mg/m\^2 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).

Cetuximab: Initial dose of 400 mg/m\^2 on Day 1 of Cycle 1 and subsequent doses of 250 mg/m\^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m\^2 Q2W in the subsequent cycles (2-week cycles).

Cixutumumab: 6 mg/kg IV infusion Q1W on Days 1, 8, and 15 of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 10 mg/kg IV Q2W in the subsequent cycles (2-week cycles).

Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met.

Spots Global Cancer Trial Database for A Study of IMC-A12 (Cixutumumab) With and Without Other Standard Chemotherapies in Participants With Lung Cancer Who Have Not Received Chemotherapy Before

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Interventions

Study Description

Keywords

Eligibility

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Contact Details

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