Dew i guess there trying to recoup some of there research expenses here on vorapaxar what a huge disappointment.
in other mrk news today. new trial for
lambrolizumab
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Study of Two Doses of MK-3475 (Lambrolizumab) Versus Docetaxel in Previously-Treated Participants With Non-Small Cell Lung Cancer (MK-3475-010)
This study is not yet open for participant recruitment.
Verified July 2013 by Merck
Sponsor:
Merck
Information provided by (Responsible Party):
MerckClinicalTrials.gov Identifier:
NCT01905657
First received: July 18, 2013
Last updated: NA
Last verified: July 2013
History: No changes posted Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record Purpose
This study will compare two doses of lambrolizumab versus docetaxel in participants with non-small cell lung cancer (NSCLC) who have experienced disease progression after platinum-containing systemic therapy. Participants will be assigned randomly to receive either Low Dose or High Dose lambrolizumab every three weeks (Q3W), or docetaxel at 75 mg/m^2 Q3W. This study will use an adaptive trial design so that the total number of participants randomized will depend upon demonstration of sufficient objective responses at interim analysis. If the lambrolizumab Low Dose arm is closed, participants may receive lambrolizumab High Dose therapy.
Condition Intervention Phase
Non Small Cell Lung Cancer (NSCLC)
Biological: Lambrolizumab
Drug: Docetaxel
Phase 2
Phase 3
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II/III Randomized Trial of Two Doses of MK-3475 (SCH900475) Versus Docetaxel in Previously Treated Subjects With Non-Small Cell Lung Cancer
Resource links provided by NLM:
MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Docetaxel
U.S. FDA Resources
Further study details as provided by Merck:
Primary Outcome Measures:
•Overall Survival (OS) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
•Progression free survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
•Number of participants experiencing adverse events [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
•Number of participants discontinuing study drug due to adverse events [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
•Overall response rate (ORR) by RECIST 1.1 [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
•Response duration by RECIST 1.1 [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
Estimated Enrollment: 920
Study Start Date: August 2013
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lambrolizumab Low Dose
Participants receive lambrolizumab, intravenously (IV) over 30 minutes Q3W Biological: Lambrolizumab
Other Names:
•SCH 900475
•MK-3475
Experimental: Lambrolizumab High Dose
Participants receive lambrolizumab, IV over 30 minutes Q3W Biological: Lambrolizumab
Other Names:
•SCH 900475
•MK-3475
Active Comparator: Docetaxel 75 mg/m^2
Participants receive 75 mg/m^2 docetaxel, IV over 1 hour Q3W Drug: Docetaxel
Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
•Life expectancy of at least 3 months
•Histologically- or cytologically-confirmed diagnosis of non-small cell lung cancer (NSCLC) that is PD-L1 positive per central laboratory review
•At least one measurable lesion
•Radiographic progression after treatment with a platinum-containing doublet
•Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Exclusion Criteria:
•Prior therapy with docetaxel for NSCLC
•Receiving systemic steroid therapy within three days prior to the first dose of study treatment or receiving any other form of immunosuppressive medication
•Expected to require any other form of systemic or localized antineoplastic therapy while on trial
•History of allogeneic tissue/solid organ transplant
•Received maintenance chemotherapy with an additional agent other than that
used in the first-line regimen ("switch maintenance")
•Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-tumor necrosis factor CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
•Known history of prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cervical cancer, and has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy
•Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
•Active autoimmune disease, or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
•Interstitial lung disease or history of pneumonitis
•Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial through 120 days after last dose of lambrolizumab or 180 days after last dose of docetaxel
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01905657 History of Changes
Other Study ID Numbers: 3475-010, 2012-004391-19
Study First Received: July 18, 2013
Last Updated: July 18, 2013
Health Authority: United States: Food and Drug Administration
Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
ClinicalTrials.gov processed this record on July 23, 2013
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