Study for the assessment of Safety and Efficacy of treatment with the study medication Ipilimumab in comparison with treatment with Pemetrexed. Affected patients are patients with recurrent / Stage IV NSCLC where the disease did not progress (growth of tumour) after 4 cycles of Chemotherapy treatment with platinum Chemotherapy. Patients are distributed by random to one of the two treatments, but will be aware which treatment they receive.
- Conditions
- SCLC is the description of a malign development of body tissues from cells in the Bronchia / Lungs where larger cells are visible per microscope.Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-000732-29-DE
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
1) Signed Written Informed Consent:
a) Willing and able to provide informed consent
2) Target Population:
a) Subjects with NSCLC of predominantly non-squamous histology documented by histology or cytology from brushing, washing or needle aspiration of a defined lesion but not from sputum cytology alone
b) Subjects must present with Stage IV or Recurrent NSCLC (per the 7th International Association for the Study of Lung Cancer (IASLC) classification)
c) Subjects must have received 4 cycles of a platinum-based chemotherapy regimen consisting of carboplatin or cisplatin combined with docetaxel, paclitaxel, vinorelbine, gemcitabine, or pemetrexed. Previous treatment with cetuximab or bevacuzimab is allowed provided these drugs are stopped at least 3 weeks prior to randomization.
d) Subjects must have stable disease or better following the 4 cycles of platinum-based chemotherapy
e) Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at study entry.
f) Accessible for treatment and follow-up. Subjects enrolled in this trial must be treated at the participating centers
3) Age and Reproductive Status:
a) Men and Women >/= 18 years of age
b) Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of ipilimumab in such a manner that the risk of pregnancy is minimized. See Section 3.3.3 for the definition of WOCBP
c) WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of investigational product
d) Women must not be breastfeeding
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 126
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 74
1) Target Disease Exceptions:
a) Brain metastases unless stable with no evidence of progression on scans for at least 30 days, non-symptomatic, and not requiring treatment with steroids
b) Malignant pleural effusion that is recurrent despite appropriate supportive care
c) Known to have an EGFR activating mutation and/or an ALK mutation
d) Have previously been treated with a tyrosine kinase inhibitor (eg., erlotinib, gefintinib, etc)
e) Previously been treated with more than 4 cycles of chemotherapy for recurrent/stage IV lung cancer
2) Medical History and Concurrent Diseases:
a) Documented history of severe autoimmune or immune mediated symptomatic disease that required prolonged (more than 2 months) systemic immunosuppressive (ie, steroids) treatment such as:
i) Ulcerative colitis and Crohn’s di sease
ii) Rheumatoid arthritis, systemic progressive sclerosis (scleroderma)
iii) Systemic Lupus Erythematosus
iv) Autoimmune vasculitis (eg, Wegener’s Granulomatosis)
b) Subjects with history of motor neuropathy considered of autoimmune origin (eg, Guillain Barré Syndrome)
c) Subjects with a history of toxic epidermal necrolysis (TEN)
d) Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent or completing questionnaires
e) Serious uncontrolled medical disorder that, in the opinion of the investigator, would impair the ability of the subject to receive protocol therapy
f) Prior malignancy, active within 5 years, except for locally curable cancers that have been apparently cured and need no subsequent therapy, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast
g) HIV, Hepatitis B, or Hepatitis C infection based on testing performed during the CA184124 screening period
h) Subjects with >/= Grade 1 peripheral neuropathy
3) Physical and Laboratory Test Findings:
a) Inadequate hematologic function defined by:
i) Absolute neutrophil count (ANC) < 1,500/mm3, or
ii) Platelet count < 100,000/mm3; or
iii) Hemoglobin level < 9 g/dL
b) Inadequate hepatic function as defined by either:
i) Total bilirubin level >/=2.5 times the upper limit of normal (ULN);
ii) AST and ALT levels >/= times the ULN or >/= times the ULN if liver metastases are present
c) Inadequate renal function defined as calculated creatinine clearance < 45 ml/min based on the standard Cockroft and Gault formula
4) Prohibited Treatments and/or Therapies:
a) Chronic use of immuno-suppressive drugs (ie, corticosteroids used in the management of cancer or non-cancer related illnesses). Use of corticosteroids are allowed if used as premedication for chemotherapy administration or on study management of an AE
b) Any non-oncology vaccine therapy, including flu vaccine, used for prevention of infectious disease for up to 4 weeks prior to or after any dose of study drug
c) Any immunotherapy for the treatment of cancer
d) Prior treatment with any inhibitor or agonist of T-cell co-stimulation
e) Unable to interrupt treatment with aspirin or non steroidal inflammatory drugs
f) Unable to take folic acid and vitamin B12
5) Sex and Reproductive Status:
a) Sexually active fertile men not using effective birth control if their partners are WOCBP.
6) Other Exclusion Criteria:
a) Prisoners or subjects who are involuntarily incarcerated
b) Subjects who are compulsorily detained for treatment of either
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