A Randomized, Double-Blind, Parallel, Three Arm, Multicenter, Phase II Trial Evaluating the Efficacy and Safety of Ipilimumab (BMS-734016) in Combination with Taxol®/Paraplatin® (Paclitaxel/Carboplatin) Compared to Taxol®/Paraplatin® Alone in Previously Untreated Subjects with Lung Cancer+ Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific, version 2.0 dated 20-Jul-07

Phase 1

• Conditions: Study Population: Men and women who are = 18 years old with histologically or cytologically confirmed lung cancer (Stage IIIb/IV NSCLC or extensive stage SCLC) with ECOG performance = 1, who have met screening laboratory requirements, and who are previously untreated. Subjects with specific underlying autoimmune diseases (particularly gastrointestinal) or paraneoplastic syndromes related to SCLC will be excluded.; MedDRA version: 9.1Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIB; MedDRA version: 9.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IV; MedDRA version: 9.1Level: PTClassification code 10041068Term: Small cell lung cancer extensive stage

• Registration Number: EUCTR2007-001256-39-FR
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-11-12
• Study Completion: 2010-07-16
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 413

Inclusion Criteria

1) Signed Written Informed Consent
a) Willing and able to give informed consent;
2) Target Population
a) Subjects with histologically- or cytologically-documented NSCLC (squamous,
adeno, large cell anaplastic, bronchioalveolar, and non-small cell carcinoma not
otherwise specified) who present with Stage IIIB/Stage IV disease (with managed
malignant pleural effusion), or recurrent disease following radiation therapy or
surgical resection. The cytological documentation of NSCLC may be from
brushing, washing or needle aspiration of a defined lesion but not from sputum
cytology alone.
OR
b) Subjects with histologically- or cytologically-documented SCLC who present
with extensive stage disease (e.g. tumor that is too widespread to be included
within the definition of limited-stage disease. Subjects with distant metastases
(M1) are always considered to have extensive-stage SCLC). The cytological
documentation of SCLC may be from brushing, washing or needle aspiration of a
defined lesion but not from sputum cytology alone.
c) Measurable tumor lesion as defined by modified WHO criteria (mWHO).
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 center(s).
3) Age and Sex
a) Men and women, = 18 years of age
Women of childbearing potential (WOCBP) must be using an adequate method of
contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of study drug in such a manner that the risk of pregnancy is minimized.
WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea = 12 consecutive months; or women on hormone replacement therapy [HRT] with documented serum follicle stimulating hormone [FSH] level > 35 mIU/mL). Even women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential.
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.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Sex and Reproductive Status
a) WOCBP who are unwilling or unable to use an acceptable method to avoid
pregnancy for the entire study period and for up to 8 weeks after the last dose of
ipilimumab.
b) Women who are pregnant or breastfeeding
c) Women with a positive pregnancy test on enrollment or prior to investigational
product administration.
d) Sexually active fertile men not using effective birth control if their partners are
WOCBP.
2) Target Disease Exceptions
a) History of or current brain metastases
3) Medical History and Concurrent Diseases
a) Autoimmune disease: subjects with a documented history of inflammatory bowel
disease, including ulcerative colitis and Crohn’s disease are excluded from this
study as are subjects with a history of symptomatic disease (e.g., rheumatoid
arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus
Erythematosus, autoimmune vasculitis [e.g., Wegener’s Granulomatosis]);
b) History and/or concurrent paraneoplastic syndromes related to SCLC;
c) Dementia, altered mental status, or any psychiatric condition that would prohibit
the understanding or rendering of informed consent or completing questionnaires;
d) A serious uncontrolled medical disorder that, in the opinion of the Investigator,
would impair the ability of the subject to receive protocol therapy;
e) Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma
in situ of the cervix or prostate cancer;
f) Known HIV or Hepatitis B or Hepatitis C infection;
g) Subjects who received prior systemic therapy for lung cancer are excluded. Prior
radiation therapy or loco-regional surgeries are allowed if performed at least 3
weeks prior to randomization date;
h) Subjects with = Grade 2 peripheral neuropathy (motor or sensory).
4) Physical and Laboratory Test Findings
a) Inadequate hematologic function defined by an absolute neutrophil count (ANC)
< 1,500/mm3, a platelet count < 100,000/mm3, or a hemoglobin level < 9 g/dL.
b) Inadequate hepatic function defined by a total bilirubin level = 2.5 times the upper
limit of normal (ULN), AST and ALT levels = 2.5 times the ULN or = 5 times the
ULN if liver metastases are present.
c) Inadequate renal function defined by a serum creatinine level = 2.5 times the
ULN.
d) Inadequate creatinine clearance defined as less than 50 mL/min.
5) Prohibited Treatments and/or Therapies
a) Chronic use of immunosuppressants and/or systemic corticosteroids (used in the
management of cancer or non-cancer-related illnesses). However, use of
corticosteroids are allowed if used as premedication for Taxol® infusion, treating
irAEs, or adrenal insufficiencies.
b) Any non-oncology vaccine therapy used for prevention of infectious diseases (for
up to 4 weeks prior to or after any dose of ipilimumab).
c) Prior treatment with a CD137 agonist or CTLA-4 inhibitor or agonist.
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 (e.g. infectious disease) illness
Eligibility criteria for this study have been carefully considered to ensure the safety of the study subjects and to ensure that the results of the study can be used. It is imperative that subjects fully meet all eligibility criteria.

Study & Design

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