Scientific Study to compare the efficiency of Ipilimumab combined with Paclitaxel and Carboplatin with Paclitaxel and carboplatin alone in the treatment of Stage IV/Recurrent Non-Small Cell Lung Cancer (NSCLC).

Phase 1

• Conditions: Stage IV/Recurrent Non-Small Cell Lung Cancer; MedDRA version: 14.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10029515Term: Non-small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-017396-19-IT
• Lead Sponsor: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-20
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 920

Inclusion Criteria

1) Signed Written Informed Consent a) Willing and able to provide informed consent 2) Target Population a) Subjects with NSCLC of predominantly 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) At least 1 measurable tumor lesion, as defined by mWHO criteria, that is not located in a previously irradiated area d) Eastern Cooperative Oncology Group (ECOG) performance status `?¤ 1 at study entry e) 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) must be using an acceptable method of contraception to avoid pregnancy throughout the study and for up to 8 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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 552
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 368

Exclusion Criteria

1) Target Disease Exceptions a) Brain metastases b) Malignant pleural effusion that is recurrent despite appropriate supportive care 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-Barre` 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 positive or active Hepatitis B or active Hepatitis C infection h) Prior systemic therapy for lung cancer including vaccines and other targeted therapies i) Prior radiation therapy or loco-regional surgeries are allowed if performed at least 3 weeks prior to the date of entry into the lead-in phase i) 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 upper limit of normal (ULN); ii) AST and ALT levels `?¥ 2.5 times the ULN or `?¥ 5 times the ULN if liver metastases are present c) Inadequate renal function defined as calculated creatinine clearance < 50 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 used for prevention of infectious disease (for up to 4 weeks prior to or after any dose of blinded study drug) c) Any immunotherapy for the treatment of cancer d) Prior treatment with any inhibitor or agonist of T-cell co-stimulation 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 a psychiatric or physical (eg, infectious disease) illness

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified