A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Participants With EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC)

Phase 1

Conditions: EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer
MedDRA version: 20.0Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2014-004824-22-DE

Lead Sponsor: Eli Lilly and Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 463

Inclusion Criteria

* Cytologically or histologically confirmed diagnosis of Stage IV NSCLC as defined by the American Joint Committee on Cancer Staging Criteria for Lung Cancer (AJCC 7th edition 2009)
* Eligible for first-line treatment with erlotinib based on previously documented evidence of tumor that has EGFR exon 19 deletion or exon 21 (L858R) substitution mutation.
* Mandatory provision of adequate archived stage IV NSCLC tissue sample.
* At least one or more measurable lesion attributed to NSCLC , documented by computed tomography (CT) scan or magnetic resonance imaging (MRI), as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
* Prior radiation therapy is allowed
* Adequate hematologic and organ function
* Eligible patients of reproductive potential (both sexes) must agree to use adequate contraceptive methods (hormonal or barrier methods) during the study period and for at least 12 weeks after the last dose of study therapy.
* Resolution to Grade =1 (except alopecia), by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), v4.0, of all clinically significant toxic effects of prior locoregional therapy, surgery, or other anticancer therapy.
* Life expectancy of at least 3 months and, in the judgment of the investigator, will be able to complete at least 2 cycles of treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 330
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 220

Exclusion Criteria

* Known T790M EGFR mutation
* Known leptomeningeal carcinomatosis, uncontrolled/unstable spinal cord compression, or brain metastases
* Major surgery within 28 days or subcutaneous venous access device placement within 7 days prior to enrollment. Any patient with postoperative bleeding complications or wound complications from a surgical procedure performed in the last 2 months will be excluded
* Pleural effusion, pericardial fluid, or ascites requiring drainage every other week or more frequently
* Superior vena cava syndrome
* Clinically relevant congestive heart failure [NYHA] II-IV; or symptomatic or poorly controlled cardiac arrhythmia
* Serious illness or medical condition including Cirrhosis at a level of Child-Pugh Class B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis. Patients with a history of hepatorenal syndrome should also be excluded.
* Uncontrolled hypertension
* Ongoing treatment with CYP3A4 inducers or strong/moderate inhibitors
* Ongoing therapy with nonsteroidal anti-inflammatory drugs for more than 2 months or other antiplatelet agents. Aspirin use at doses up to 325 mg/day is permitted
* History of gross hemoptysis within 2 months
* Significant bleeding disorders, vasculitis, or experienced Grade 3/4 GI bleeding within 3 months
* Radiologically documented evidence of major blood vessel invasion or encasement by cancer
* Radiographic evidence of intratumor cavitation, regardless of tumor histology
* History of gastrointestinal perforation, peptic ulceration, diverticular disease, and/or fistulae within 6 months
* History of bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection, Crohn's disease, ulcerative colitis, or chronic diarrhea
* History of any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months
* The patient has any known significant ophthalmologic abnormalities of the surface of the eye
* The patient requires daily use of prescription or over-the-counter proton pump inhibitors
* Any prior anticancer therapy for Stage IIIB/IV NSCLC
* Any evidence of clinically active interstitial lung disease. Asymptomatic patients with chronic, stable, radiographic changes are eligible
* Preexisting idiopathic pulmonary fibrosis as evidenced by CT scan/X-ray at baseline; have or had any disease of acute lung injury, idiopathic pulmonary fibrosis, or pneumoconiosis evident on an X-ray; have or had any disease of radiation pneumonia or drug-induced pneumonia
* The patient has SPO2 < 94 (room air)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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