NCT01232452|CompletedPhase 2ResultsDMC

A Study in Non-Small Cell Lung Cancer

An Open-label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of Cisplatin and Pemetrexed With or Without Cixutumumab as First-Line Therapy in Patients With Advanced Nonsquamous Non-Small Cell Lung Carcinoma

Eli Lilly and Company ClinicalTrials.gov

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2 other identifiers

13973I5A-MC-JAEM

Study Type

interventional

Target

172

Locations

12 countries

Sites

Timeline

RegisteredNov 2010

StartedApr 2011

CompletionJun 2016

Brief Summary

The primary purpose of this study is to evaluate the hypothesis that cixutumumab given in combination with cisplatin and pemetrexed is superior to cisplatin and pemetrexed as first-line therapy for patients with advanced nonsquamous non-small cell lung carcinoma (NSCLC).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

172

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Apr 2011

Longer than P75 for phase_2

Geographic Reach

12 countries

44 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.2 years study duration

First Submitted

Initial submission to the registry

October 28, 2010

Completed

5 days until next milestone

First Posted

Study publicly available on registry

November 2, 2010

Completed

5 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed

3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed

2 years until next milestone

Results Posted

Study results publicly available

June 12, 2018

Completed

Last Updated

September 20, 2019

Status Verified

September 1, 2019

Enrollment Period

1.8 years

First QC Date

October 28, 2010

Results QC Date

March 17, 2018

Last Update Submit

September 6, 2019

Conditions

Non-Small-Cell Lung Carcinoma

Keywords

lung canceradvancednon-small cell

Outcome Measures

Primary Outcomes (1)

Progression-free Survival (PFS)
PFS was defined as the time from date of randomization until the date of disease progression, or death from any cause, whichever was first. Disease progression was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions. Participants without documentation for disease progression or death were censored at the date of last tumor assessment. The PFS was estimated following the Kaplan-Meier method.
Randomization Date to Disease Progression or Death From Any Cause Up to 18.3 Months

Secondary Outcomes (11)

Percentage of Participants Achieving an Objective Response Rate (ORR)
Randomization to Disease Progression Up to 18.3 Months
Overall Survival (OS)
Randomization Date to Death From Any Cause Up to 20 Months
Duration of Response (DOR)
Time from Response to Disease Progression or Death from Any Cause Up to 20 Months
Time to Progressive Disease (TTPS)
Randomization Date to Disease Progression Up to 18.3 Months
Time to Worsening of Symptoms as Measured by Lung Cancer Symptom Scale (LCSS) Score
Time to worsening of symptoms as measured by LCSS score Up to 18.3 Months
+6 more secondary outcomes

Study Arms (2)

Pemetrexed + Cisplatin + Cixutumumab

EXPERIMENTAL

Induction Treatment: Pemetrexed 500 mg/m\^2 plus cisplatin 75 mg/m\^2 plus cixutumumab 20 mg/kg given intravenously (IV) on Day 1 of a 21 day cycle for up to 4 cycles. Two additional cycles of cisplatin may be given (6 cycles total) for patients with significant tumor size reduction, after sponsor approval. Maintenance Therapy: Pemetrexed 500 mg/m\^2 plus cixutumumab 20 mg/kg given IV every 21 days until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.

Drug: PemetrexedDrug: CisplatinDrug: Cixutumumab

Pemetrexed + Cisplatin

ACTIVE COMPARATOR

Induction Treatment: Pemetrexed 500 mg/m\^2 plus cisplatin 75 mg/m\^2 given intravenously (IV) on Day 1 of a 21 day cycle for up to 4 cycles. Two additional cycles of cisplatin may be given (6 cycles total) for patients with significant tumor size reduction, after sponsor approval. Maintenance Therapy: Pemetrexed 500 mg/m\^2 given IV every 21 days until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.

Drug: PemetrexedDrug: Cisplatin

Interventions

PemetrexedDRUG

Administered intravenously (IV)

Also known as: Alimta, LY231514

Pemetrexed + CisplatinPemetrexed + Cisplatin + Cixutumumab

CisplatinDRUG

Administered IV

Pemetrexed + CisplatinPemetrexed + Cisplatin + Cixutumumab

CixutumumabDRUG

Administered IV

Also known as: LY3012217

Pemetrexed + Cisplatin + Cixutumumab

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

The participant has histologically or cytologically confirmed, nonsquamous (adenocarcinoma/large cell or other) NSCLC.
The participant has Stage IV disease at the time of study entry.
Participants with treated brain metastases are eligible if they are clinically stable with regard to neurologic function, off steroids after cranial irradiation (whole brain radiation therapy, focal radiation therapy, and stereotactic radiosurgery) ending at least 14 days prior to randomization, or after surgical resection performed at least 28 days prior to randomization. The participant may have no evidence of Grade 1 (or greater) Central Nervous System (CNS) hemorrhage based on pretreatment scans(performed within 21 days before randomization).
The participant has measurable or nonmeasurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 guidelines.
The participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
If prior adjuvant or neoadjuvant chemotherapy, the last dose of adjuvant or neoadjuvant treatment was administered at least 6 months prior to randomization.
The participant has adequate bone marrow reserve, and renal and hepatic function
The participant has fasting serum glucose less than or equal to 125 mg/dL, and hemoglobin A1C less than or equal to 6%.
Females with reproductive potential: Must have a negative serum or urine pregnancy test within 7 days prior to the first dose of any study drug.
Males and females with reproductive potential: Must agree to use medically approved contraceptive precautions during the study and for 6 months following the last dose of any study drug.
The participant has the ability to understand and the willingness to sign a written informed consent form.
Previous radiation therapy is allowed to less than 25% of the bone marrow, but should have been limited and must not have included whole pelvis radiation.
The participant has archived tumor tissue available for analysis (can be either primary tumor or metastases).
The participant has an estimated life expectancy of at least 12 weeks.

You may not qualify if:

Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Participants who have squamous histology.
The participant's tumor fully or partially contains Small Cell Lung Cancer (SCLC).
The participant has leptomeningeal disease.
The participant is currently or has previously received chemotherapy for advanced (Stage IV) NSCLC.
The participant has a history of treatment with other agents targeting the Insulin-like or Epidermal Growth factor receptors.
Participants who have received prior Pemetrexed treatment.
The patient has a known allergy/history of hypersensitivity reaction to any of the treatment components.
The participant has diabetes mellitus as defined by being treated with glucose lowering medications in the past 3 months prior to enrollment.
The participant has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics, symptomatic congestive heart failure, uncontrolled hypertension, clinically significant cardiac arrhythmia,or psychiatric/social situations that would limit compliance with study requirements.
The participant has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy.
The participant has undergone major surgery within 28 days prior to randomization.
The participant has received a prior autologous or allogeneic organ or tissue transplantation.
The participant is pregnant or lactating.
The participant has a history of another primary cancer, with the exception of the following: curatively resected nonmelanomatous skin cancer, curatively treated carcinoma in situ, or other primary solid tumor treated with curative intent and no known active disease present and no treatment administered during the last 5 years.
+7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (44)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Chicago, Illinois, 60611, United States

Location

Hackensack, New Jersey, 07601, United States

Location

Portland, Oregon, 97213, United States

Location

Memphis, Tennessee, 38120, United States

Location

Spokane, Washington, 99218, United States

Location

Buenos Aires, 1120, Argentina

Location

La Rioja, 5300, Argentina

Location

Mendoza, 5500, Argentina

Location

Santa Fe, 3000, Argentina

Location

Viedma, 8500, Argentina

Location

Brussels, 1000, Belgium

Location

Duffel, 2570, Belgium

Location

Liège, 4000, Belgium

Location

Barretos, 14784700, Brazil

Location

Ijuí, 98700 000, Brazil

Location

Porto Alegre, 90430-090, Brazil

Location

Rio de Janeiro, 20231-050, Brazil

Location

Salvador, 41253-190, Brazil

Location

São José do Rio Preto, 15025-100, Brazil

Location

São Paulo, 01509-900, Brazil

Location

Oshawa, Ontario, L1G 2B9, Canada

Location

Caen, 14033, France

Location

Clermont-Ferrand, 63003, France

Location

Braunschweig, 38114, Germany

Location

Erfurt, 99089, Germany

Location

Großhansdorf, 22927, Germany

Location

Halle, 06120, Germany

Location

Hanover, 30659, Germany

Location

Ulm, 89081, Germany

Location

Beer Yaakov, 70300, Israel

Location

Tel Aviv, 64239, Israel

Location

Tel Litwinsky, 52661, Israel

Location

Milan, 20121, Italy

Location

Orbassano, 10043, Italy

Location

Perugia, 06156, Italy

Location

Saronno, 21047, Italy

Location

's-Hertogenbosch, 5223 GZ, Netherlands

Location

Harderwijk, 3844 DG, Netherlands

Location

Barcelona, 08003, Spain

Location

Girona, 17007, Spain

Location

Madrid, 28041, Spain

Location

Palma de Mallorca, 07198, Spain

Location

Edirne, 22000, Turkey (Türkiye)

Location

Zeytinburnu, 034760, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Interventions

PemetrexedCisplatincixutumumab

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DicarboxylicChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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 DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 28, 2010

First Posted

November 2, 2010

Study Start

April 1, 2011

Primary Completion

January 1, 2013

Study Completion

June 1, 2016

Last Updated

September 20, 2019

Results First Posted

June 12, 2018

Record last verified: 2019-09

Data Sharing

IPD Sharing: Will share
Shared Documents: STUDY PROTOCOL, SAP, CSR
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

TU(2)AR(5)BE(3)IL(3)FR(2)BR(7)US(5)ES(4)DE(6)IT(4)CA(1)NL(2)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (2)

Pemetrexed + Cisplatin + Cixutumumab

Pemetrexed + Cisplatin

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (44)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations