A Phase 2 Study of MM-121 in Combination with Chemotherapy versus Chemotherapy Alone in Patients with Heregulin Positive Non-Small Cell Lung Cancer.
- Conditions
- MedDRA version: 18.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]MedDRA version: 18.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Heregulin Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- Registration Number
- EUCTR2014-003673-42-ES
- Lead Sponsor
- Merrimack Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
INCLUSION CRITERIA FOR ALL PATIENTS:
a) Patients with a diagnosis of cytologically or histologically confirmed NSCLC with either:
• Metastatic disease (stage IV) or
• Stage IIIB disease not amenable to surgery with curative intent
b) Disease progression or evidence of recurrent or persistent disease documented by radiographic assessment following the last systemic therapy
c) Received one prior platinum-based regimen for management of primary or recurrent disease
d) Clinically eligible for intended chemotherapy, docetaxel or pemetrexed, once every three weeks per the investigator's judgment
e) Must have:
• Available recent tumor specimen collected following completion of most recent therapy OR
• At least one lesion amenable to either core needle biopsy or fine needle aspiration
f) = 18 years of age
g) Able to provide informed consent, or have a legal representative able and willing to do so
ADDITIONAL INCLUSION CRITERIA FOR THE INTERVENTIONAL GROUP:
h) A positive in-situ hybridization (ISH) test for heregulin with a score of = 1+, as determined by centralized testing
i) Measureable disease in accordance with RECIST v1.1
j) ECOG performance status (PS) of 0 or 1
k) Screening ECG without clinically significant abnormalities
l) Adequate bone marrow reserve as evidenced by:
• ANC > 1,500/µl and
• Platelet count = 100,000/µl
• Hemoglobin = 9 g/dL
m) Adequate renal function as evidenced by a serum/plasma creatinine = 1.5 x ULN for patients receiving docetaxel and a creatinine clearance = 45 mL/min for patients receiving pemetrexed
n) For patients receiving pemetrexed: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x ULN (= 5 x ULN is acceptable if liver metastases are present).
o) For patients receiving docetaxel: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT ) = 1.5 x ULN, Alkaline phosphatase (AP) = 2.5 ULN and serum/plasma total bilirubin within normal institutional limits
p) Women of childbearing potential, as well as fertile men and their partners, must be willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of study drug(s) (an effective form of contraception is an oral contraceptive or a double barrier method) or for 90 days following the last dose of study drug(s), or greater, as in accordance with the label requirements or institutional guidelines for docetaxel/pemetrexed.
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
a) Known Anaplastic Lymphoma Kinase (ALK) gene rearrangement or presence of exon 19 deletion or exon 21 (L858R) substitution of the EGFR gene
b) Pregnant or lactating
c) Prior radiation therapy to >25% of bone marrow-bearing areas
d) Received >2 prior systemic anti-cancer drug regimen for locally advanced disease
• Maintenance therapy with pemetrexed following first-line treatment for Stage IIIB or Stage IV disease is counted as one line of therapy
e) Patients who have received prior docetaxel for advanced/ metastatic disease are not eligible for the docetaxel-containing chemotherapy backbone
f) Patients who have received prior pemetrexed for advanced/ metastatic disease and/or maintenance therapy are not eligible for the pemetrexed-containing chemotherapy backbone
g) Received other recent antitumor therapy including:
• Investigational therapy administered within the 28 days or 5 half-lives, whichever is shorter, prior to the first scheduled day of dosing in this study
• Radiation or other standard systemic therapy within 14 days prior to the first scheduled dose in this study, including, in addition (if necessary), the timeframe for resolution of any actual or anticipated toxicities from such radiation
h) CTCAE grade 3 or higher peripheral neuropathy
i) Presence of an unexplained fever > 38.5°C during screening visits that does not resolve prior to the first day of dosing. If the fever and active infection have resolved prior to randomization, the patient will be eligible. At the discretion of the investigator, patients with tumor fever may be enrolled.
j) Symptomatic CNS metastases or CNS metastases requiring steroids
k) Use of strong CYP3A4 inhibitors for patients considered for the docetaxel backbone.
l) Any other active malignancy requiring systemic therapy
m) Known hypersensitivity to any of the components of MM-121 or previous hypersensitivity reactions to fully human monoclonal antibodies
n) History of severe allergic reactions to docetaxel or pemetrexed
o) Known hypersensitivity to polysorbate (Tween) 80 or arginine
p) Clinically significant cardiac disease, including: symptomatic congestive heart failure, unstable angina, acute myocardial infarction within 1 year months of planned first dose, or unstable cardiac arrhythmia requiring therapy (including torsades de pointes)..
q) Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, known human immunodeficiency virus (HIV) infection, or active B or C infection.
r) Patients who are not appropriate candidates for participation in this clinical study for any other reason as deemed by the investigator
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