Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)
The purpose of the study is to determine whether ipilimumab given with paclitaxel/carboplatin has clinical benefit when compared with paclitaxel/carboplatin alone in patients with previously untreated lung cancer.
Checked against the public recordLast updated Jul 18, 2018 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Bristol-Myers Squibb
- Interventions being studied
- Drug: Ipilimumab; Drug: Placebo; Drug: Paclitaxel; Drug: Carboplatin
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Histologically or cytologically confirmed lung cancer (Stage IIIb/IV nonsmall-cell lung cancer or extensive stage small-cell lung cancer \[SCLC\]) * Measurable tumor lesion (as long as it is not located in a previously irradiated area) as defined by modified World Health Organization criteria * Eastern Cooperative Oncology Group performance status of ≤1 at study entry * Accessible for treatment and follow-up Exclusion Criteria: * Brain metastases * Malignant pleural effusion * Autoimmune disease * Motor neuropathy of autoimmune origin * SCLC-related paraneoplastic syndromes * Any concurrent malignancy other than nonmelanoma skin cancer; carcinoma in situ of the cervix or breast; or prostate cancer treated with systemic therapy (participants with a previous malignancy but without evidence of disease for 5 years were allowed to enter the study) * Prior systemic therapy for lung cancer. Prior radiation therapy or locoregional surgeries performed later than at least 3 weeks prior to randomization date were allowed. * Grade 2 peripheral neuropathy (motor or sensory) * Known HIV or hepatitis B or C infection * Chronic use of immunosuppressants and/or systemic corticosteroids (used in the management of cancer or noncancer-related illnesses). However, use of corticosteroids was allowed if used as premedication for paclitaxel infusion or for treating immune-related adverse events or adrenal insufficiencies. * Inadequate hematologic function defined by an absolute neutrophil count \<1,500/mm\^3, a platelet count \<100,000/mm\^3, or hemoglobin level \<9 g/dL. * Inadequate hepatic function defined by a total bilirubin level \>2.0 times the upper limit of normal (ULN), or ≥2.5 times the ULN if liver metastases are present, aspartate aminotransferase and alanine aminotransferase levels ≥2.5 times the ULN or ≥5 times the ULN if liver metastases are present. * Inadequate renal function defined by a serum creatinine level ≥2.5 times the ULN * Inadequate creatinine clearance defined as less than 50 mL/min.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Birmingham Hematology & Oncology Assoc. LlcBirmingham, Alabama
- Mayo ClinicScottsdale, Arizona
- Acrc/Arizona Clinical Research Center, Inc.Tucson, Arizona
- Compassionate Cancer Care Medical GroupCorona, California
- Compassionate Cancer Care Medical Group, Inc.Fountain Valley, California
- The Angeles Clinic & Research Institute, IncLos Angeles, California
- Oncology Care Medical AssociatesMontebello, California
- Compassionate Cancer Care Medical GroupRiverside, California
- Sharp Clinical Oncology ResearchSan Diego, California
- M D Anderson Cancer Center- OrlandoOrlando, Florida
- Georgia Cancer SpecialistsAtlanta, Georgia
- University Of Chicago Medical CenterChicago, Illinois
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 18, 2018. Always confirm current availability with the study team.