- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00527735
Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)
18. juni 2018 opdateret af: Bristol-Myers Squibb
A Randomized, Double Blind, Parallel, Three Arm Trial Evaluating the Efficacy and Safety of Ipilimumab (BMS-734016) in Combination With Paclitaxel/Carboplatin Compared to Paclitaxel/Carboplatin Alone in Previously Untreated Subjects With Lung Cancer
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.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
334
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Arkhangelsk, Den Russiske Føderation, 163045
- Local Institution
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Chelyabinsk, Den Russiske Føderation, 454087
- Local Institution
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Ivanovo, Den Russiske Føderation, 153013
- Local Institution
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Moscow, Den Russiske Føderation, 115478
- Local Institution
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Moscow, Den Russiske Føderation, 105077
- Local Institution
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Moscow, Den Russiske Føderation, 125284
- Local Institution
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Pyatigorsk, Den Russiske Føderation, 357502
- Local Institution
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Saint-Petersburg, Den Russiske Føderation, 190005
- Local Institution
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Sochi, Den Russiske Føderation, 354057
- Local Institution
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St. Petersburg, Den Russiske Føderation, 197022
- Local Institution
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St. Petersburg, Den Russiske Føderation, 198255
- Local Institution
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St. Petersburg, Den Russiske Føderation, 194044
- Local Institution
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St. Petersburg, Den Russiske Føderation, 194291
- Local Institution
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Alabama
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Birmingham, Alabama, Forenede Stater, 35235
- Birmingham Hematology & Oncology Assoc. Llc
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Arizona
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Scottsdale, Arizona, Forenede Stater, 85259
- Mayo Clinic
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Tucson, Arizona, Forenede Stater, 85715
- Acrc/Arizona Clinical Research Center, Inc.
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California
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Corona, California, Forenede Stater, 92879
- Compassionate Cancer Care Medical Group
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Fountain Valley, California, Forenede Stater, 92708
- Compassionate Cancer Care Medical Group, Inc.
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Los Angeles, California, Forenede Stater, 90025
- The Angeles Clinic & Research Institute, Inc
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Montebello, California, Forenede Stater, 90640
- Oncology Care Medical Associates
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Riverside, California, Forenede Stater, 92501
- Compassionate Cancer Care Medical Group
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San Diego, California, Forenede Stater, 92123
- Sharp Clinical Oncology Research
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Florida
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Orlando, Florida, Forenede Stater, 32806
- M D Anderson Cancer Center- Orlando
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Georgia
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Atlanta, Georgia, Forenede Stater, 30341
- Georgia Cancer Specialists
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Illinois
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Chicago, Illinois, Forenede Stater, 60637
- University of Chicago Medical Center
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Park Ridge, Illinois, Forenede Stater, 60068
- Local Institution
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Kentucky
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Hazard, Kentucky, Forenede Stater, 41701
- Kentucky Cancer Clinic
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Maryland
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Hagerstown, Maryland, Forenede Stater, 21740
- The John R. Marsh Cancer Center
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55455
- The Cancer Center
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89135
- Nevada Cancer Institute
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03756
- Dartmouth-Hitchcock Medical Center
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New York
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New York, New York, Forenede Stater, 10017
- Local Institution
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North Carolina
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Concord, North Carolina, Forenede Stater, 28025
- Cmc-Northeast/ Northeast Oncology Associates
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Ohio
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Canton, Ohio, Forenede Stater, 44718
- Gabrail Cancer Center
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Columbus, Ohio, Forenede Stater, 43235
- Hematology Oncology Consultants, Inc
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Pennsylvania
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Langhorne, Pennsylvania, Forenede Stater, 19047
- St. Mary Medical Center
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Sayre, Pennsylvania, Forenede Stater, 18840
- Guthrie Clinical Research
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South Carolina
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Sumter, South Carolina, Forenede Stater, 29150
- Santee Hematology/Oncology
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Texas
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Lubbock, Texas, Forenede Stater, 79415
- Southwest Cancer Treatment And Research Center
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Belfort, Frankrig, 90016
- Local Institution
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Caen, Frankrig, 14076
- Local Institution
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Marseille Cedex 9, Frankrig, 13274
- Local Institution
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Rennes Cedex 9, Frankrig, 35033
- Local Institution
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Vellore, Indien, 632004
- Local Institution
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, Indien, 500082
- Local Institution
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Gujarat
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Navrangpura, Ahmedabad, Gujarat, Indien, 380009
- Local Institution
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Karnataka
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Manipal, Karnataka, Indien, 576104
- Local Institution
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Kerala
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Trivandrum, Kerala, Indien, 695011
- Local Institution
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Genova, Italien, 16132
- Local Institution
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Siena, Italien, 53100
- Local Institution
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Torino, Italien, 10143
- Local Institution
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Gdansk, Polen, 80-952
- Local Institution
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Krakow, Polen, 31-826
- Local Institution
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Olsztyn, Polen, 10-513
- Local Institution
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Szczecin, Polen, 70-891
- Local Institution
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Bochum, Tyskland, 44791
- Local Institution
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Coswig, Tyskland, 01640
- Local Institution
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Ebensfeld, Tyskland, 96250
- Local Institution
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Grosshansdorf, Tyskland, 22927
- Local Institution
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Halle (Saale), Tyskland, 06120
- Local Institution
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Hamburg, Tyskland, 21075
- Local Institution
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Koeln, Tyskland, 51109
- Local Institution
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Leipzig, Tyskland, 04103
- Local Institution
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Mainz, Tyskland, 55131
- Local Institution
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Muenchen, Tyskland, 81675
- Local Institution
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Dnipropetrovsk, Ukraine, 49102
- Local Institution
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Donetsk, Ukraine, 83092
- Local Institution
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Kharkov, Ukraine, 46023
- Local Institution
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Lviv, Ukraine, 79031
- Local Institution
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Ternopol, Ukraine, 46023
- Local Institution
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Uzhgorod, Ukraine, 88014
- Local Institution
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Ipilimumab/ placebo + paclitaxel + carboplatin (concurrent)
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Ipilimumab, 10 mg/kg, administered as a single-dose, intravenously (IV), over 90 minutes depending on randomization every 3 weeks (up to 6 doses).
Participants could receive additional maintenance ipilimumab at a dose of 10 mg/kg every 12 weeks starting 24 weeks after the first ipilimumab dose.
Matched placebo for ipilimumab administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction.
Participants could also receive additional maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first placebo dose.
175 mg/m^2, administered as a single IV dose over 3 hours every 3 weeks (up to 6 doses).
Dose modifications (reductions as well as delays) done as per product label.
Area under the concentration curve (AUC)=6, administered as a single IV dose over 30 minutes every 3 weeks (up to 6 doses) as per randomization.
Dose modifications (reductions as well as delays) done as per product label.
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Eksperimentel: Ipilimumab/ placebo + paclitaxel + carboplatin (sequential)
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Ipilimumab, 10 mg/kg, administered as a single-dose, intravenously (IV), over 90 minutes depending on randomization every 3 weeks (up to 6 doses).
Participants could receive additional maintenance ipilimumab at a dose of 10 mg/kg every 12 weeks starting 24 weeks after the first ipilimumab dose.
Matched placebo for ipilimumab administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction.
Participants could also receive additional maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first placebo dose.
175 mg/m^2, administered as a single IV dose over 3 hours every 3 weeks (up to 6 doses).
Dose modifications (reductions as well as delays) done as per product label.
Area under the concentration curve (AUC)=6, administered as a single IV dose over 30 minutes every 3 weeks (up to 6 doses) as per randomization.
Dose modifications (reductions as well as delays) done as per product label.
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Aktiv komparator: Ipilimumab placebo + paclitaxel + carboplatin
|
Matched placebo for ipilimumab administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction.
Participants could also receive additional maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first placebo dose.
175 mg/m^2, administered as a single IV dose over 3 hours every 3 weeks (up to 6 doses).
Dose modifications (reductions as well as delays) done as per product label.
Area under the concentration curve (AUC)=6, administered as a single IV dose over 30 minutes every 3 weeks (up to 6 doses) as per randomization.
Dose modifications (reductions as well as delays) done as per product label.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Immune-related Progression-free Survival (irPFS) in Participants With Nonsmall-cell Lung Cancer (NSCLC) Per Immune-related Response Criteria (irRC)
Tidsramme: Tumor assessed at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until immune-related Progressive Disease (irPD) or death (of censored, maximum reached: 16.5 months)
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irPFS is defined as the time between the randomization date and date of immune-related Progressive Disease (irPD) (at least 25% increase percentage change in total tumor burden, including new lesions) or death, whichever occurs first.
For patients with no recorded postbaseline tumor assessments, irPFS is censored at randomization.
Participant who die without reported irPD are considered to have progressed on the date of death.
For those who remain alive and have no irPD, irPFS is censored on the date of last evaluable tumor assessment.
Independent review committee performed tumor assessment.
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Tumor assessed at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until immune-related Progressive Disease (irPD) or death (of censored, maximum reached: 16.5 months)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Progression-free Survival (PFS) in Participants With NSCLC Per Modified World Health Organization (mWHO) Criteria
Tidsramme: Randomization date to date of progression or death (of censored, maximum reached: 13.6 months)
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By mWHO criteria, PFS is defined as the time between the randomization date and the date of progression or death, whichever occurs first.
For participants with no recorded postbaseline tumor assessment, PFS was censored at the day of randomization.
A participant who died without reported prior progression was considered to have progressed on the date of death.
For those who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment.
Independent review committee performed tumor assessment.
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Randomization date to date of progression or death (of censored, maximum reached: 13.6 months)
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Overall Survival in Participants With NSCLC
Tidsramme: Randomization date to date of death (of censored, maximum reached: 26.5 months)
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Overall Survival is defined as the time from the date of randomization until the date of death.
For participants who have not died, Overall Survival was censored at the recorded last date of contact; participants with a missing recorded last date of contact were censored at the last date the participant was known to be alive.
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Randomization date to date of death (of censored, maximum reached: 26.5 months)
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Best Overall Response Rate (BORR) Per mWHO Criteria in Participants With NSCLC and SCLC
Tidsramme: Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance
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mWHO criteria define BORR as the number of patients with best overall response of Complete Response (CR) or Partial Response (PR), divided by the total number of participants in the data set (multiplied by 100 for percentage).
CR=Complete disappearance of all index lesions; PR=decrease from baseline of >=50% in the sum of products of the 2 largest perpendicular diameters of all index lesions.
Independent review committee performed tumor assessment.
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Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance
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Immune-related Best Overall Response Rate (irBORR) Per irRC in Participants With NSCLC and Small-cell Lung Cancer (SCLC)
Tidsramme: Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance
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irBORR=number of participants with irBORR of immune-related Complete Response (irCR) or immune-related Partial Response (irPR), divided by total participants in the data set.
irCR=Complete disappearance of all index lesions.
irPR=Decrease, relative to baseline, of 50% or greater in the sum of the products of the 2 largest perpendicular diameters of all index and of all new measurable lesions.
Independent review committee performed the tumor assessments.
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Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance
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Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC
Tidsramme: Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until irPD, progressive disease, or death (maximum reached: 22 months)
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irDCR is defined as the proportion of participants whose immune-related best overall response is irPR, irCR, or immune-related Stable Disease (irSD) in the analysis data set.
irSD=Does not meet criteria for irCR or irPR, in the absence of progressive disease.
By mWHO criteria, DCR is defined as the proportion of participants whose best overall response is PR, CR, or SD in the analysis data set.
SD=A decrease or tumor stabilization of 1 or more nonindex lesions.
Independent review committee assessed response.
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Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until irPD, progressive disease, or death (maximum reached: 22 months)
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Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC
Tidsramme: Date of irCR or irPR to date of irPD or death (maximum reached: 14.2 months)
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irDoR is defined as the time between the date of response of confirmed irCR or irPR and the date of irPD or death, whichever occurs first.
For those participants who remain alive and did progress following response, irDoR was censored on the date of last evaluable tumor assessment.
By mWHO criteria, DoR is defined as the time between the date of response of confirmed CR or PR and the date of PD or death, whichever occurs first.
For those who remain alive and did not progress following response, DoR was censored on the date of last evaluable tumor assessment.
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Date of irCR or irPR to date of irPD or death (maximum reached: 14.2 months)
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Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade
Tidsramme: Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose)
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AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.
SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Drug-related=possibly, probably, or certainly related to and of unknown relationship to study drug.
Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
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Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose)
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Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade
Tidsramme: At screening; predose Day 1; and Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent
|
CTC, Version 3 used to assess parameters.
LLN=lower limit of normal.
CTC criteria: ANC=absolute neutrophil count.
White blood cells Grade (Gr) 1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L.
ANC Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L.
Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L.
Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL.
|
At screening; predose Day 1; and Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent
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irPFS in Participants With SCLC Per irRC
Tidsramme: Randomization date to date of irPD or death (maximum reached: 22 months)
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IRC performed TA.
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Randomization date to date of irPD or death (maximum reached: 22 months)
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Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade
Tidsramme: At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent
|
ULN=Upper limit of normal among all laboratory ranges.
ALT=alanine transaminase; AST=aspartate aminotransferase; ALK=alkaline phosphatase.
CTC grade criteria: ALT Grade 1:>ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN.
AST Grade 1: >ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN.
Total bilirubin Grade 1: >ULN to 1.5*ULN; Grade 2: >1.5 to 3.0*ULN; Grade 3: >3.0 to 10.0*ULN; Grade 4: >10.0*ULN.
ALK (U/L) G1:>ULN to 2.5*ULN, G2:>2.5 to 5.0*ULN, G3:>5.0 to 20.0*ULN, G4:>20.0*ULN.
|
At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent
|
Number of Participants With NSCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings
Tidsramme: At screening; Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent
|
Vital signs measurements consisted of systolic and diastolic blood pressure, heart rate, temperature, and respiratory rate.
Physical examinations assessed weight, height, performance status, and body surface area.
|
At screening; Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent
|
Percentage of Participants With NSCLC Who Have Abnormalities in Pancreatic Enzyme Clinical Laboratory Test Results by Worst CTC Grade
Tidsramme: At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment
|
ULN=upper limit of normal.
Lipase (U/L) Gr 1: 1.1 to 1.39*ULN; Gr 2: >1.5 to 2.0*ULN; Gr 3: 2.5 to 5; Gr 4: 5*ULN.
Amylase (U/L) Gr 1: >ULN to 1.5*ULN; Grade 2 >1.5 to 2.0*ULN, Grade 3 >2.0 to 5.0*ULN, Grade 4 >5.0*ULN.
Creatine (mg/dL) Grade 1: >ULN to 1.5*ULN, Gr 2: 1.5 to 3.0*ULN, Gr 3: >3.0 to 6.0*ULN, Gr 4: >6.0*ULN.
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At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment
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Number of Participants With NSCLC Who Have Positive Human Antihuman Antibody (HAHA) Status Postbaseline
Tidsramme: Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment
|
An electrochemilumiluminescent immunoassay was used to detect HAHA antibodies to ipilimumab in human serum.
Baseline, either negative or positive, is the maximum of all measurements closest and prior to the first ipilimumab dose.
Positive status postbaseline=participants with an increase in HAHA measurement from baseline.
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Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment
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Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade
Tidsramme: Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose)
|
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.
SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Drug-related=possibly, probably, or certainly related to and of unknown relationship to study drug.
Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
|
Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose)
|
Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade
Tidsramme: At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment
|
CTC, Version 3 used to assess parameters.
LLN=lower limit of normal.
CTC criteria: ANC=absolute neutrophil count.
White blood cells Gr 1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L.
ANC Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L.
Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L.
Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL.
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At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment
|
Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade
Tidsramme: At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment
|
ALT=alanine aminotransferase; AST=aspartate aminotransferase; ALK=alkaline phosphatase.
ULN=Upper limit of normal among all laboratory ranges.
CTC grade criteria: ALT Grade 1:>ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN.
AST Grade 1: >ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN.
Total bilirubin Grade 1: >ULN to 1.5*ULN; Grade 2: >1.5 to 3.0*ULN; Grade 3: >3.0 to 10.0*ULN; Grade 4: >10.0*ULN.
ALK (U/L) G1:>ULN to 2.5*ULN, G2:>2.5 to 5.0*ULN, G3:>5.0 to 20.0*ULN, G4:>20.0*ULN.
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At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment
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Percentage of Participants With SCLC Who Have Abnormalities in Pancreatic Enzyme and Other Clinical Laboratory Test Results by Worst CTC Grade
Tidsramme: At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment
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ULN=upper limit of normal.
Lipase (U/L) Grade (Gr) 1: 1.1 to 1.39*ULN; Gr 2: >1.5 to 2.0*ULN; Gr 3: 2.5 to 5; Gr 4: 5*ULN.
Amylase (U/L) Gr 1: >ULN to 1.5*ULN; Gr 2 >1.5 to 2.0*ULN, Gr 3 >2.0 to 5.0*ULN, Gr 4 >5.0*ULN.
Creatine (mg/dL) Gr 1: >ULN to 1.5*ULN, Gr 2: 1.5 to 3.0*ULN, Gr 3: >3.0 to 6.0*ULN, Gr 4: >6.0*ULN.
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At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment
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Progression-free Survival (PFS) in Participants With SCLC Per mWHO Criteria
Tidsramme: Randomization date to date of progression or death (of censored, maximum reached: 22 months)
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By mWHO criteria, PFS is defined as the time between the randomization date and the date of progression or death, whichever occurs first.
For participants with no recorded postbaseline tumor assessment, PFS was censored at the day of randomization.
A participant who died without reported prior progression was considered to have progressed on the date of death.
For those who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment.
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Randomization date to date of progression or death (of censored, maximum reached: 22 months)
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Number of Participants With SCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings
Tidsramme: Predose Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until end of treatment
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Vital signs measurements consisted of systolic and diastolic blood pressure, heart rate, temperature, and respiratory rate.
Physical examinations assessed weight, height, performance status, and body surface area.
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Predose Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until end of treatment
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Number of Participants With SCLC Who Have Positive HAHA Status Postbaseline
Tidsramme: Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment
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An electrochemilumiluminescent immunoassay was used to detect HAHA antibodies to ipilimumab in human serum.
Baseline, either negative or positive, is the maximum of all measurements closest and prior to the first ipilimumab dose.
Positive status postbaseline=participants with an increase in HAHA measurement from baseline.
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Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment
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Overall Survival in Participants With SCLC
Tidsramme: Randomization date to date of death (of censored, maximum reached: 22 months)
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Overall Survival is defined as the time from the date of randomization until the date of death.
For participants who have not died, Overall Survival was censored at the recorded last date of contact; participants with a missing recorded last date of contact were censored at the last date the participant was known to be alive.
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Randomization date to date of death (of censored, maximum reached: 22 months)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2008
Primær færdiggørelse (Faktiske)
1. oktober 2009
Studieafslutning (Faktiske)
1. december 2011
Datoer for studieregistrering
Først indsendt
7. september 2007
Først indsendt, der opfyldte QC-kriterier
10. september 2007
Først opslået (Skøn)
11. september 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. juli 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. juni 2018
Sidst verificeret
1. juni 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Neoplasmer
- Lungesygdomme
- Neoplasmer efter sted
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karcinom, ikke-småcellet lunge
- Småcellet lungekarcinom
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, fytogene
- Antineoplastiske midler, immunologiske
- Immune Checkpoint-hæmmere
- Carboplatin
- Paclitaxel
- Ipilimumab
Andre undersøgelses-id-numre
- CA184-041
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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