Overview

This trial is active, not recruiting.

Condition squamous non-small cell lung cancer
Treatments necitumumab, gemcitabine, cisplatin
Phase phase 1/phase 2
Target EGFR
Sponsor Eli Lilly and Company
Start date May 2013
End date June 2017
Trial size 192 participants
Trial identifier NCT01763788, 14461, I4X-JE-JFCM

Summary

The purpose of the Phase 1b portion of the study is to investigate how the body tolerates necitumumab, in combination with gemcitabine and cisplatin chemotherapy as first line treatment in participants with Stage IV squamous NSCLC and to determine the recommended dose for the subsequent Phase 2 portion of the study.

The purpose of the Phase 2 portion of the study is to evaluate the efficacy of necitumumab in combination with gemcitabine and cisplatin chemotherapy in participants with Stage IV squamous NSCLC in a first-line setting.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Phase 1b Dose Escalation: Necitumumab 800 milligram (mg) on Days 1 and 8 of every 21 day cycle, administered as an intravenous (IV) infusion. Gemcitabine (Gem) dose escalation of 1000 or 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of every 21 day cycle, administered as an IV infusion for a maximum of 4 cycles. Cisplatin (Cis) 75 mg/m^2 on Day 1 of every 21 day cycle, administered as an IV infusion for a maximum of 4 cycles. Phase 2 Randomized: Necitumumab 800 mg on Days 1 and 8 of every 21 day cycle, administered as an IV infusion. Gemcitabine at fixed dose determined in Phase 1b (1000 or 1250 mg/m^2) on Days 1 and 8 of every 21 day cycle, administered as an IV infusion for a maximum of 4 cycles. Cisplatin 75 mg/m^2 on Day 1 of every 21 day cycle, administered as an IV infusion for a maximum of 4 cycles.
necitumumab IMC-11F8
Administered IV
gemcitabine LY188011
Administered IV
cisplatin
Administered IV
(Active Comparator)
Phase 2 Randomized: Gemcitabine at fixed dose determined in Phase 1b (1000 to 1250 mg/m^2) on Day 1 and Day 8 of every 21 day cycle,administered as an IV infusion over approximately 30 minutes for a maximum of 4 cycles. Cisplatin 75 mg/m^2 on Day 1 of every 21 day cycle, administered as an IV infusion over approximately 120 minutes for a maximum of 4 cycles .
gemcitabine LY188011
Administered IV
cisplatin
Administered IV

Primary Outcomes

Measure
Phase 1b: Number of Participants with Dose Limiting Toxicities (DLTs)
time frame: Day 1 to Day 21 in Cycle 1 (estimated up to 21 days)
Phase 2: Overall Survival (OS)
time frame: Baseline to Death from Any Cause (estimated up to 39 months)

Secondary Outcomes

Measure
Phase 2: Progression Free Survival (PFS)
time frame: Baseline to Measured Progressive Disease or Death from Any Cause (estimated up to 39 months)
Phase 1b: Number of Participants who Achieve Best Overall Tumor Response of Complete Response or Partial Response (Objective Tumor Response Rate [ORR])
time frame: Baseline to Measured Progressive Disease (estimated up to 39 months)
Phase 2: Number of Participants who Achieve Best Overall Tumor Response of Complete Response or Partial Response (Objective Tumor Response Rate [ORR])
time frame: Baseline to Measured Progressive Disease (estimated up to 39 months)
Phase 2: Time to Treatment Failure (TTF)
time frame: Baseline to Measured Progressive Disease or Death from Disease Any Cause (estimated up to 39 months)
Phase 2: Change from Baseline in EuroQol 5-Dimensional Scale (EQ-5D)
time frame: Baseline to Measured Progressive Disease (estimated up to 39 months)
Phase 2: Change from Baseline in Lung Cancer Symptom Scale (LCSS)
time frame: Baseline to Measured Progressive Disease or Participant Stops Study (estimated up to 39 months)
Phase 1b/2: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Necitumumab
time frame: Baseline up to Cycle 4 (estimated up to 3 months)
Phase 1b: PK: Cmax of Gemcitabine and Cisplatin
time frame: Baseline up to Cycle 1 (estimated up to 1 Month)
Phase 1b: PK: Area Under the Concentration Curve (AUC) of Necitumumab
time frame: Baseline up to Cycle 4 (estimated up to 3 months)
Phase 1b: PK: AUC of Gemcitabine and Cisplatin
time frame: Baseline up to Cycle 4 (estimated up to 3 months)
Phase 2: PK: Minimum Concentration (Ctrough) of Necitumumab
time frame: Baseline up to Cycle 4 (estimated up to 3 months)
Number of Participants with Anti Necitumumab Antibodies
time frame: Baseline up to 30 Days Post Last Infusion (estimated up to 39 months)

Eligibility Criteria

Male or female participants at least 20 years old.

Inclusion Criteria: - Squamous Non-Small Cell Lung Cancer Disease - Clinical Stage IV - Measurable or nonmeasurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1 - No prior chemotherapy regimen, surgery and chest radiotherapy - Adequate organ function - Estimated life expectancy of at least 12 weeks Exclusion Criteria: - Has undergone major surgery within 28 days prior to enrollment or have planned major surgery, subcutaneous venous access device placement within 7 days prior to enrollment - Has undergone any prior radiation therapy, except for Gamma Knife radiation and palliative radiation treatment at least 14 days have elapsed from last radiation treatment prior to enrollment - Has brain metastases that are symptomatic or require surgery, medication and radiotherapy except Gamma Knife - Has superior vena cava syndrome - Has clinically relevant coronary artery disease or uncontrolled congestive - heart failure - Has uncontrolled hypertension - Has diabetes requiring insulin - Has an angina or has experienced myocardial infarction within 6 months prior to enrollment - Has an Acquired Immunodeficiency Syndrome (AIDS)-related illness - Has evidence of or test positive test results for hepatitis B, or hepatitis C virus antibodies - Has a known allergy and history of hypersensitivity reaction - Has significant third-space fluid retention - Has history of interstitial pneumonitis - Has an ongoing or active infection - Has a history of significant neurological or psychiatric disorders - Has a Grade 2 peripheral neuropathy

Additional Information

Official title An Open-Label, Multicenter, Phase 1b/2 Study to Evaluate Necitumumab in Combination With Gemcitabine and Cisplatin in the First-Line Treatment of Patients With Advanced (Stage IV) Squamous Non-Small Cell Lung Cancer (NSCLC)
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.