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Study of Pembrolizumab Versus Docetaxel in Participants Previously Treated for Non-Small Cell Lung Cancer (MK-3475-033)

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ClinicalTrials.gov Identifier: NCT02864394
Recruitment Status : Recruiting
First Posted : August 12, 2016
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The purpose of this study is to assess the efficacy of pembrolizumab (MK-3475) versus docetaxel in participants with non-small cell lung cancer (NSCLC) with programmed cell death ligand 1 (PD-L1) positive tumors who have experienced disease progression after platinum-containing systemic therapy. The primary hypothesis of this study is that pembrolizumab (MK-3475) prolongs overall survival (OS) and progression-free survival (PFS) compared to docetaxel in participants with PD-L1 positive tumors

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Biological: pembrolizumab 2 mg/kg Drug: Docetaxel 75 mg/m^2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 740 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multinational, Multicenter, Phase III, Randomized Open-label Trial of Pembrolizumab Versus Docetaxel in Previously Treated Subjects With Non-Small Cell Lung Cancer
Actual Study Start Date : September 7, 2016
Estimated Primary Completion Date : January 14, 2019
Estimated Study Completion Date : January 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pembrolizumab (MK-3475) 2mg/kg

Participants with NSCLC receive pembrolizumab 2mg/kg intravenously (IV) over 30 minutes every 3 weeks (Q3W) for up to 35 doses (approximately 24 months).

Participants who attain a confirmed complete response (CR) per Response Criteria in Solid Tumor Version 1.1 (RECIST 1.1) or those that stop trial therapy after 35 treatment administrations for reasons other than disease progression or intolerability may be eligible for re-treatment with open-label pembrolizumab as monotherapy after they have experienced radiographic disease progression for up to 17 doses (approximately an additional 12 months).

Biological: pembrolizumab 2 mg/kg
IV infusion
Other Names:
  • KEYTRUDA®
  • MK-3475

Experimental: Docetaxel 75 mg/m^2
Participants with NSCLC receive Docetaxel 75 mg/m^2 IV over 1 hour Q3W until disease progression, toxicity, investigator's decision to discontinue or consent withdrawal
Drug: Docetaxel 75 mg/m^2
IV infusion
Other Name: TAXOTERE®




Primary Outcome Measures :
  1. OS in Participants with Tumors that are Positive for PD-L1 Expression (Tumor Proportion Score 1 to 49%) [ Time Frame: From time of screening until end of follow-up (Up to 26 months) ]
  2. OS in Participants with Tumors that are Positive for PD-L1 Expression (Tumor Proportion Score ≥50%) [ Time Frame: From time of screening until end of follow-up (Up to 26 months) ]
  3. PFS per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants with Tumors that are Positive for PD-L1 Expression (Tumor Proportion Score 1 to 49%) [ Time Frame: From time of screening until end of follow-up (Up to 26 months) ]
  4. PFS per RECIST 1.1 as Assessed by BICR in Participants with Tumors that are Positive for PD-L1 Expression (Tumor Proportion Score ≥50%) [ Time Frame: From time of screening until end of follow-up (Up to 26 months) ]

Secondary Outcome Measures :
  1. Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR in Participants with Tumors that are Positive for PD-L1 Expression (Tumor Proportion Score 1 to 49%) [ Time Frame: From time of screening until end of follow-up (Up to 26 months) ]
  2. DOR per RECIST 1.1 as Assessed by BICR in Participants with Tumors that are Positive for PD-L1 Expression (Tumor Proportion Score ≥50%) [ Time Frame: From time of screening until end of follow-up (Up to 26 months) ]
  3. Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR in Participants with Tumors that are Positive for PD-L1 Expression (Tumor Proportion Score 1 to 49%) [ Time Frame: From time of screening until end of follow-up (Up to 26 months) ]
  4. ORR per RECIST 1.1 as Assessed by BICR in Participants with Tumors that are Positive for PD-L1 Expression (Tumor Proportion Score ≥50%) [ Time Frame: From time of screening until end of follow-up (Up to 26 months) ]
  5. Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: From time of first dose until the end of follow-up (up to 39 months) ]
  6. Number of Participants Who Discontinue Study Drug Due to an AE [ Time Frame: From time of first dose until the end of study drug (up to 36 months) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chinese participants must be born, raised, and reside in China
  • Has a histologically or cytologically confirmed diagnosis of stage IIIB/IV or recurrent NSCLC and have at least one measurable lesion as defined by RECIST 1.1
  • Has a life expectancy of at ≥3 months
  • Has progression of disease (investigator determined) per RECIST 1.1 after treatment with at least two cycles of a platinum-containing doublet
  • Has documentation of epidermal growth factor receptor (EGRF) mutation and anaplastic lymphoma kinase (ALK) translocation status
  • Participants with an EGFR sensitizing mutation tumor will be excluded
  • Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 10 days prior to study start
  • Has provided archival tumor tissue sample or newly obtained formalin fixed tumor tissue from a recent biopsy of a tumor lesion not previously irradiated
  • Has a PD-L1 positive tumor as determined by immunohistochemistry at a central laboratory
  • Has resolution of toxic effect(s) of the most recent prior chemotherapy to Grade 1 or less (except alopecia)
  • Has recovered from the toxicity and/or complications of any recent major surgery or radiation therapy
  • Females must not be pregnant (negative urine or serum human chorionic gonadotropin test within 72 hours prior to receiving the first dose of study medication)
  • Female and male participants of reproductive potential must agree to use adequate contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy

Exclusion Criteria:

  • Has received prior therapy with docetaxel for NSCLC
  • Is currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of study treatment
  • Is receiving systemic steroid therapy within 3 days prior to the first dose of study treatment or receiving any other form of immunosuppressive
  • Is expected to require any other form of systemic or localized antineoplastic therapy while on study including maintenance therapy with another agent for NSCLC or radiation therapy
  • Has received prior systemic cytotoxic chemotherapy, antineoplastic biological therapy (e.g., cetuximab), any other agents used as systemic treatment for cancer, or major surgery within 3 weeks of the first dose of study treatment; received thoracic radiation therapy of > 30 Gray Units (Gy) within 6 months of the first dose of study treatment; received prior ALK-directed tyrosine kinase inhibitor therapy or completed palliative radiotherapy of 30 Gy or less within 7 days of the first dose of study treatment
  • Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-PD-L1, anti-PD-L2, with an agent directed to an agonist or antagonist T-cell check point receptor, or if the subject has previously participated in Merck sponsored clinical trials evaluating pembrolizumab (MK-3475)
  • Has a known additional malignancy that is progressing or requires active treatment, with the exception of early stage cancers, treated with curative intent, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy
  • Has known active central nervous system metastases and/or carcinomatous meningitis
  • Has active autoimmune disease that has required systemic treatment in past 2 years
  • Has had an allogeneic tissue/solid organ transplant
  • Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
  • Has received or will receive a live vaccine within 30 days prior to the first administration of study medication
  • Has an active infection requiring intravenous systemic therapy
  • Has known history of Human Immunodeficiency Virus (HIV) (HIV ½ antibodies)
  • Has known active Hepatitis B or C
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • Is, at the time of signing informed consent, a regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol)
  • Is pregnant or breastfeeding, or expecting to conceive or father children starting with the screening visit (Visit 1) through 120 days after the last dose of pembrolizumab (MK-3475) or 180 days after the last dose of docetaxel
  • Requires treatment with a strong inhibitor of Cytochrome P450 3A4

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02864394


Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
Argentina
Merck Sharp & Dohme Recruiting
Buenos Aires, Argentina
Contact: Claudia Beatriz Trillo    54 11 6090 7336      
Chile
Merck Sharp & Dohme (I.A.) Corp. Recruiting
Santiago, Chile
Contact: Patricia Morales    56-2-26558912      
China
Merck Sharp & Dohme (China) Ltd. Recruiting
Beijing, China
Contact: Zaiqi Wang    86 10 5860 9288      
Mexico
MSD Recruiting
Mexico City, Mexico
Contact: Alexandra Barajas    52 5554819650      
Philippines
Merck Sharp & Dohme (I.A.) Corporation Recruiting
Makati, Philippines
Contact: Georgina Arnold    61289888212      
Taiwan
Merck Sharp & Dohme (I.A.) Corp. Recruiting
Taipei, Taiwan
Contact: Keris Huang    886 266316032      
Thailand
MSD (Thailand) Ltd. Recruiting
Bangkok, Thailand
Contact: Georgina Arnold    61289888212      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02864394     History of Changes
Other Study ID Numbers: 3475-033
MK-3475-033 ( Other Identifier: Merck Registration Number )
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Pembrolizumab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action