Phase 3 Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone
- Conditions
- Extensive Stage Disease Small Cell Lung Cancer (ED-SCLC)MedDRA version: 17.1Level: PTClassification code 10041068Term: Small cell lung cancer extensive stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-000850-48-NL
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1100
1) Signed Written Informed Consent
a) Willing and able to provide informed consent.
2) Target Population
a) Subjects with SCLC 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 extensive stage disease (VALG classification) and defined as disease beyond ipsilateral hemithorax
which may include malignant pleural effusion or pericardial effusion or hematogenous metastases.
c) Eastern Cooperative Oncology Group (ECOG) performance status = 1.
d) Accessible for treatment and follow-up. Subjects enrolled in this trial must be treated at the participating centers.
e) Re-enrollment: permitted for a subject who has discontinued the
study as a pretreatment failure (i.e., subject has not been randomized/has not been treated). If re-enrolled, the subject must be re-consented.
3) Age and Reproductive Status
a) Men and Women = 18 years of age.
b) Women of childbearing potential (WOCBP) must use method(s) of contraception as indicated in the Informed Consent Form. For a teratogenic study drug, and/or when there is insufficient information to assess teratogenicity (preclinical studies have not been done), a highly effective method(s) of contraception (failure rate of less than 1% per year) is required. The individual methods of contraception and duration should be determined in consultation with the investigator. WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with blinded study drug plus 5 half-lives (75 days) plus 30 days (duration of ovulatory cycle) for a total of 105 days post completion of blinded study therapy.
c) Women must not be breastfeeding.
d) Sexually active fertile men must use effective birth control if their partners are WOCBP. Men that are sexually active with WOCBP must follow instructions for birth control for the entire duration of treatment with blinded study therapy, plus 5 half-lives of ipilimumab (75 days) plus 90 days (duration of sperm turnover) for a total of 165 days post completion of blinded study therapy.
e) Not applicable per Protocol Amendment 10.
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 660
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 440
1) Target Disease Exceptions
a) CNS metastases, unless non-symptomatic (ie, no neurological deficit, epilepsy or other signs and symptoms typical of CNS metastases), and not requiring treatment with steroids or anticonvulsant medications. In addition, if treated with radiation therapy, CNS metastases must be stable with no evidence of progression on scans for at least 30 days from initial radiologic diagnosis of CNS metastases.
b) Pleural effusion which cannot be controlled with appropriate
interventions.
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 disease, 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) Interstitial pneumonia or pulmonary fibrosis.
e) Paraneoplastic autoimmune syndrome
f) Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent or completing questionnaires.
g) Serious uncontrolled medical disorder that, in the opinion of the investigator, would impair the ability of the subject to receive protocol therapy.
h) 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.
i) HIV, active Hepatitis B, or active Hepatitis C infection, based on testing performed during the CA184156 screening period. In the event of a positive HIV or anti-HCV antibody test, results of confirmatory testing must be awaited before randomization.
j) Prior systemic therapy for lung cancer, including vaccines and other targeted therapies.
i) Prior radiation therapy or loco-regional surgeries are allowed.
k) Subjects with = Grade 2 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 ULN;
ii) AST and ALT levels = 2.5 times the ULN or = 5 times the ULN if livermetastases are present.
c) Inadequate renal function defined as calculated creatinine clearance < 50 ml/min based on the standard Cockroft and Gault formula.
d) Sodium (Na) < 130 mmol/l.
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 immunotherapy for the treatment of cancer.
c) Prior treatment with any inhibitor or agonist of T-cell co-stimulation.
5) Other Exclusion Criteria
a) Prisoners or subjects who are involuntarily incarcerated.
b) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
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