A Study of Nab-Paclitaxel and Carboplatin Plus Necitumumab (LY3012211) in Participants With Stage IV Squamous NSCLC
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: Necitumumab
Administered IV
Other Names:
Drug: Nab-Paclitaxel
Administered IV
Other Names:
Drug: Carboplatin
Administered IV
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response or Partial Response (Objective Tumor Response Rate [ORR]) [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 Outcome Measures
- Progression Free Survival (PFS) [From Date of Randomization to Measured Progressive Disease or Death Due to Any Cause (Up to 18 Months)]
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.
- Overall Survival (OS) [From Date of Randomization until Death Due to Any Cause (Up to 18 Months)]
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.
- 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)]
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.
- Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab, Nab-Paclitaxel, and Carboplatin [Cycle 3 and cycle 4: predose]
The Cmin is the minimum observed serum/plasma concentration of Necitumumab, Nab-Paclitaxel, and Carboplatin.
- PK: Maximum Concentration (Cmax) of Necitumumab, Nab-Paclitaxel, and Carboplatin [Cycle 1, 3 and 4: predose and <15minutes (min) post end-of-infusion]
The Cmax is the maximum observed serum/plasma concentration of Necitumumab, Nab-Paclitaxel, and Carboplatin.
- Immunogenicity: Number of Participants Developing Anti-drug Antibodies to Necitumumab [Predose Cycle 1 Through Short Term Follow Up (Up To 18 Months)]
A participant was considered to have an anti-drug antibody response if anti-drug antibodies (ADA) were detected at any time point.
Eligibility Criteria
Criteria
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 1.
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Florida Hospital Cancer Institute | Orlando | Florida | United States | 32804 |
Sponsors and Collaborators
- Eli Lilly and Company
- Celgene
Investigators
- 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
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- 15529
- I4X-MC-JFCP
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Participants with known best overall response and off study treatment were considered to be completed. |
| Arm/Group Title | Necitumumab + Nab-Paclitaxel + Carboplatin |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Induction Regimen | |
| STARTED | 54 |
| Received at Least 1 Dose of Study Drug | 54 |
| COMPLETED | 47 |
| NOT COMPLETED | 7 |
| Period Title: Induction Regimen | |
| STARTED | 34 |
| COMPLETED | 32 |
| NOT COMPLETED | 2 |
Baseline Characteristics
| Arm/Group Title | Necitumumab + Nab-Paclitaxel + Carboplatin |
|---|---|
| Arm/Group Description | 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. |
| Overall Participants | 54 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
65.96
(7.48)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
12
22.2%
|
| Male |
42
77.8%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
4
7.4%
|
| Not Hispanic or Latino |
50
92.6%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
1
1.9%
|
| White |
53
98.1%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (Count of Participants) | |
| United States |
15
27.8%
|
| Germany |
4
7.4%
|
| Spain |
27
50%
|
| Greece |
8
14.8%
|
Outcome Measures
| Title | Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response or Partial Response (Objective Tumor Response Rate [ORR]) |
|---|---|
| Description | 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. |
| Time Frame | From Date of Randomization to Objective Disease Progression (Up to 18 Months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Necitumumab + Nab-Paclitaxel + Carboplatin |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 51 |
| Number [percentage of participants] |
51.0
94.4%
|
| Title | Progression Free Survival (PFS) |
|---|---|
| Description | 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. |
| Time Frame | From Date of Randomization to Measured Progressive Disease or Death Due to Any Cause (Up to 18 Months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least 1 dose of study drug. Censored participants = 15. |
| Arm/Group Title | Necitumumab + Nab-Paclitaxel + Carboplatin |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 54 |
| Median (95% Confidence Interval) [Months] |
5.59
|
| Title | Overall Survival (OS) |
|---|---|
| Description | 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. |
| Time Frame | From Date of Randomization until Death Due to Any Cause (Up to 18 Months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least 1 dose of study drug. Censored participants = 35. |
| Arm/Group Title | Necitumumab + Nab-Paclitaxel + Carboplatin |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 54 |
| Median (95% Confidence Interval) [Months] |
15.54
|
| Title | Percentage of Participants Who Achieve Best Overall Disease Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR]) |
|---|---|
| Description | 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. |
| Time Frame | From Date of Randomization to Objective Disease Progression or Start of New Anticancer Therapy (Up to 18 Months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least 1 dose of study drug and who had a complete radiographic assessment at baseline. |
| Arm/Group Title | Necitumumab + Nab-Paclitaxel + Carboplatin |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 51 |
| Number [percentage of participants] |
78.4
145.2%
|
| Title | Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab, Nab-Paclitaxel, and Carboplatin |
|---|---|
| Description | The Cmin is the minimum observed serum/plasma concentration of Necitumumab, Nab-Paclitaxel, and Carboplatin. |
| Time Frame | Cycle 3 and cycle 4: predose |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least 1 dose of study drug and had evaluable PK data. |
| Arm/Group Title | Necitumumab | Carboplatin | Paclitaxel |
|---|---|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 37 | 32 | 3 |
| Cycle 3 |
65.2
(86.9)
|
0.131
(36)
|
33.6
(393)
|
| Cycle 4 |
90
(74.9)
|
0.209
(197)
|
107
(313)
|
| Title | PK: Maximum Concentration (Cmax) of Necitumumab, Nab-Paclitaxel, and Carboplatin |
|---|---|
| Description | The Cmax is the maximum observed serum/plasma concentration of Necitumumab, Nab-Paclitaxel, and Carboplatin. |
| Time Frame | Cycle 1, 3 and 4: predose and <15minutes (min) post end-of-infusion |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least 1 dose of study drug and had evaluable PK data. |
| Arm/Group Title | Necitumumab | Carboplatin | Paclitaxel |
|---|---|---|---|
| Arm/Group Description | Necitumumab administered IV 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. |
| Measure Participants | 36 | 32 | 37 |
| Cycle 1 |
231
(27.1)
|
16.4
(22)
|
343
(81.2)
|
| Cycle 3 |
291
(46.5)
|
16
(26.4)
|
284
(73)
|
| Cycle 4 |
277
(42.5)
|
10.5
(160)
|
221
(77.6)
|
| Title | Immunogenicity: Number of Participants Developing Anti-drug Antibodies to Necitumumab |
|---|---|
| Description | A participant was considered to have an anti-drug antibody response if anti-drug antibodies (ADA) were detected at any time point. |
| Time Frame | Predose Cycle 1 Through Short Term Follow Up (Up To 18 Months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least 1 dose of study drug and had evaluable data for antibodies. |
| Arm/Group Title | Necitumumab + Nab-Paclitaxel + Carboplatin |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 54 |
| Count of Participants [Participants] |
3
5.6%
|
Adverse Events
| Time Frame | Baseline Up to 49 Months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | 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. | |||
| Arm/Group Title | Necitumumab + Nab-paclitaxel + Carboplatin: Induction Phase | Necitumumab + Nab-paclitaxel: Maintenance Phase | ||
| Arm/Group Description | 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 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. | ||
All Cause Mortality |
||||
| Necitumumab + Nab-paclitaxel + Carboplatin: Induction Phase | Necitumumab + Nab-paclitaxel: Maintenance Phase | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/54 (5.6%) | 1/34 (2.9%) | ||
Serious Adverse Events |
||||
| Necitumumab + Nab-paclitaxel + Carboplatin: Induction Phase | Necitumumab + Nab-paclitaxel: Maintenance Phase | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 18/54 (33.3%) | 5/34 (14.7%) | ||
| Blood and lymphatic system disorders | ||||
| Febrile neutropenia | 1/54 (1.9%) | 2 | 0/34 (0%) | 0 |
| Leukopenia | 1/54 (1.9%) | 1 | 0/34 (0%) | 0 |
| Neutropenia | 1/54 (1.9%) | 1 | 0/34 (0%) | 0 |
| Cardiac disorders | ||||
| Atrial fibrillation | 1/54 (1.9%) | 1 | 0/34 (0%) | 0 |
| Myocardial infarction | 0/54 (0%) | 0 | 1/34 (2.9%) | 1 |
| Gastrointestinal disorders | ||||
| Diarrhoea | 2/54 (3.7%) | 2 | 0/34 (0%) | 0 |
| Gastric ulcer | 1/54 (1.9%) | 1 | 0/34 (0%) | 0 |
| Gastrointestinal pain | 1/54 (1.9%) | 1 | 0/34 (0%) | 0 |
| Ileus | 1/54 (1.9%) | 1 | 0/34 (0%) | 0 |
| Nausea | 2/54 (3.7%) | 2 | 0/34 (0%) | 0 |
| Small intestinal perforation | 1/54 (1.9%) | 1 | 0/34 (0%) | 0 |
| Vomiting | 1/54 (1.9%) | 1 | 0/34 (0%) | 0 |
| General disorders | ||||
| Death | 0/54 (0%) | 0 | 1/34 (2.9%) | 1 |
| Fatigue | 2/54 (3.7%) | 2 | 1/34 (2.9%) | 1 |
| Multiple organ dysfunction syndrome | 1/54 (1.9%) | 1 | 0/34 (0%) | 0 |
| Immune system disorders | ||||
| Hypersensitivity | 1/54 (1.9%) | 1 | 0/34 (0%) | 0 |
| Infections and infestations | ||||
| Diverticulitis | 1/54 (1.9%) | 1 | 0/34 (0%) | 0 |
| Gastroenteritis | 1/54 (1.9%) | 1 | 0/34 (0%) | 0 |
| Lung infection | 1/54 (1.9%) | 1 | 0/34 (0%) | 0 |
| Pneumonia | 0/54 (0%) | 0 | 1/34 (2.9%) | 1 |
| Pulmonary sepsis | 1/54 (1.9%) | 1 | 0/34 (0%) | 0 |
| Respiratory tract infection | 2/54 (3.7%) | 2 | 0/34 (0%) | 0 |
| Sepsis | 1/54 (1.9%) | 1 | 0/34 (0%) | 0 |
| Urinary tract infection | 1/54 (1.9%) | 1 | 0/34 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Fall | 1/54 (1.9%) | 1 | 1/34 (2.9%) | 1 |
| Femur fracture | 1/54 (1.9%) | 1 | 1/34 (2.9%) | 1 |
| Hip fracture | 1/54 (1.9%) | 1 | 0/34 (0%) | 0 |
| Investigations | ||||
| Neutrophil count decreased | 2/54 (3.7%) | 2 | 0/34 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| Dehydration | 1/54 (1.9%) | 1 | 0/34 (0%) | 0 |
| Hyperglycaemia | 1/54 (1.9%) | 1 | 0/34 (0%) | 0 |
| Hypomagnesaemia | 1/54 (1.9%) | 1 | 0/34 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Pathological fracture | 1/54 (1.9%) | 1 | 0/34 (0%) | 0 |
| Nervous system disorders | ||||
| Cerebrovascular accident | 1/54 (1.9%) | 1 | 0/34 (0%) | 0 |
| Psychiatric disorders | ||||
| Delirium | 1/54 (1.9%) | 1 | 0/34 (0%) | 0 |
| Renal and urinary disorders | ||||
| Urinary retention | 0/54 (0%) | 0 | 1/34 (2.9%) | 2 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Chronic obstructive pulmonary disease | 1/54 (1.9%) | 1 | 0/34 (0%) | 0 |
| Interstitial lung disease | 1/54 (1.9%) | 1 | 0/34 (0%) | 0 |
| Pneumothorax | 1/54 (1.9%) | 1 | 0/34 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Rash maculo-papular | 1/54 (1.9%) | 1 | 0/34 (0%) | 0 |
| Vascular disorders | ||||
| Peripheral ischaemia | 1/54 (1.9%) | 1 | 0/34 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Necitumumab + Nab-paclitaxel + Carboplatin: Induction Phase | Necitumumab + Nab-paclitaxel: Maintenance Phase | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 54/54 (100%) | 31/34 (91.2%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 34/54 (63%) | 101 | 15/34 (44.1%) | 27 |
| Leukopenia | 4/54 (7.4%) | 4 | 0/34 (0%) | 0 |
| Neutropenia | 3/54 (5.6%) | 6 | 0/34 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Constipation | 18/54 (33.3%) | 24 | 2/34 (5.9%) | 2 |
| Diarrhoea | 19/54 (35.2%) | 36 | 4/34 (11.8%) | 6 |
| Nausea | 16/54 (29.6%) | 25 | 2/34 (5.9%) | 3 |
| Stomatitis | 7/54 (13%) | 11 | 2/34 (5.9%) | 2 |
| Vomiting | 10/54 (18.5%) | 14 | 3/34 (8.8%) | 3 |
| General disorders | ||||
| Asthenia | 8/54 (14.8%) | 14 | 2/34 (5.9%) | 2 |
| Fatigue | 32/54 (59.3%) | 77 | 6/34 (17.6%) | 10 |
| Mucosal inflammation | 3/54 (5.6%) | 8 | 0/34 (0%) | 0 |
| Oedema peripheral | 6/54 (11.1%) | 6 | 2/34 (5.9%) | 2 |
| Pyrexia | 4/54 (7.4%) | 4 | 3/34 (8.8%) | 3 |
| Infections and infestations | ||||
| Conjunctivitis | 3/54 (5.6%) | 4 | 1/34 (2.9%) | 3 |
| Paronychia | 2/54 (3.7%) | 2 | 5/34 (14.7%) | 9 |
| Respiratory tract infection | 9/54 (16.7%) | 12 | 6/34 (17.6%) | 8 |
| Urinary tract infection | 3/54 (5.6%) | 3 | 2/34 (5.9%) | 2 |
| Vaginal infection | 1/12 (8.3%) | 1 | 0/6 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Fall | 3/54 (5.6%) | 3 | 0/34 (0%) | 0 |
| Investigations | ||||
| Alanine aminotransferase increased | 4/54 (7.4%) | 4 | 1/34 (2.9%) | 1 |
| Aspartate aminotransferase increased | 4/54 (7.4%) | 6 | 2/34 (5.9%) | 2 |
| Blood cholesterol increased | 1/54 (1.9%) | 1 | 2/34 (5.9%) | 2 |
| Blood creatinine increased | 6/54 (11.1%) | 8 | 2/34 (5.9%) | 3 |
| Lymphocyte count decreased | 6/54 (11.1%) | 22 | 6/34 (17.6%) | 11 |
| Neutrophil count decreased | 32/54 (59.3%) | 85 | 1/34 (2.9%) | 1 |
| Platelet count decreased | 17/54 (31.5%) | 38 | 2/34 (5.9%) | 2 |
| Weight decreased | 5/54 (9.3%) | 5 | 0/34 (0%) | 0 |
| White blood cell count decreased | 12/54 (22.2%) | 46 | 1/34 (2.9%) | 1 |
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 13/54 (24.1%) | 22 | 1/34 (2.9%) | 1 |
| Hypoalbuminaemia | 7/54 (13%) | 21 | 1/34 (2.9%) | 1 |
| Hypocalcaemia | 10/54 (18.5%) | 16 | 1/34 (2.9%) | 3 |
| Hypoglycaemia | 1/54 (1.9%) | 1 | 2/34 (5.9%) | 2 |
| Hypokalaemia | 10/54 (18.5%) | 14 | 0/34 (0%) | 0 |
| Hypomagnesaemia | 26/54 (48.1%) | 60 | 7/34 (20.6%) | 25 |
| Hyponatraemia | 5/54 (9.3%) | 9 | 0/34 (0%) | 0 |
| Hypophosphataemia | 12/54 (22.2%) | 27 | 2/34 (5.9%) | 5 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 5/54 (9.3%) | 5 | 1/34 (2.9%) | 1 |
| Back pain | 5/54 (9.3%) | 6 | 2/34 (5.9%) | 3 |
| Muscular weakness | 3/54 (5.6%) | 3 | 0/34 (0%) | 0 |
| Musculoskeletal chest pain | 3/54 (5.6%) | 3 | 0/34 (0%) | 0 |
| Myalgia | 5/54 (9.3%) | 5 | 0/34 (0%) | 0 |
| Pain in extremity | 3/54 (5.6%) | 4 | 1/34 (2.9%) | 1 |
| Nervous system disorders | ||||
| Dizziness | 2/54 (3.7%) | 2 | 2/34 (5.9%) | 2 |
| Dysgeusia | 5/54 (9.3%) | 6 | 1/34 (2.9%) | 1 |
| Paraesthesia | 1/54 (1.9%) | 1 | 4/34 (11.8%) | 6 |
| Peripheral motor neuropathy | 4/54 (7.4%) | 6 | 2/34 (5.9%) | 7 |
| Peripheral sensory neuropathy | 7/54 (13%) | 9 | 9/34 (26.5%) | 17 |
| Psychiatric disorders | ||||
| Depression | 4/54 (7.4%) | 4 | 0/34 (0%) | 0 |
| Insomnia | 5/54 (9.3%) | 5 | 0/34 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 4/54 (7.4%) | 4 | 7/34 (20.6%) | 7 |
| Dysphonia | 2/54 (3.7%) | 2 | 2/34 (5.9%) | 2 |
| Dyspnoea | 12/54 (22.2%) | 14 | 3/34 (8.8%) | 4 |
| Epistaxis | 11/54 (20.4%) | 16 | 1/34 (2.9%) | 5 |
| Haemoptysis | 2/54 (3.7%) | 2 | 2/34 (5.9%) | 2 |
| Nasal congestion | 6/54 (11.1%) | 6 | 0/34 (0%) | 0 |
| Oropharyngeal pain | 3/54 (5.6%) | 3 | 0/34 (0%) | 0 |
| Productive cough | 3/54 (5.6%) | 4 | 0/34 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 8/54 (14.8%) | 8 | 0/34 (0%) | 0 |
| Dermatitis acneiform | 16/54 (29.6%) | 32 | 4/34 (11.8%) | 5 |
| Dry skin | 8/54 (14.8%) | 11 | 5/34 (14.7%) | 5 |
| Nail discolouration | 0/54 (0%) | 0 | 2/34 (5.9%) | 4 |
| Pruritus | 4/54 (7.4%) | 5 | 0/34 (0%) | 0 |
| Rash | 20/54 (37%) | 59 | 6/34 (17.6%) | 9 |
| Skin fissures | 5/54 (9.3%) | 7 | 1/34 (2.9%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Chief Medical Officer |
|---|---|
| Organization | Eli Lilly and Company |
| Phone | 800-545-5979 |
| clinicaltrials.gov@lilly.com |
- 15529
- I4X-MC-JFCP