Skip to main content

Summary

for people ages 18 years and up (full criteria)
study started
estimated completion:

Description

Summary

This study compared two doses of pembrolizumab (MK-3475) versus docetaxel in participants with non-small cell lung cancer (NSCLC) who had experienced disease progression after platinum-containing systemic therapy. Participants were assigned randomly to receive either pembrolizumab 2 mg/kg once every three weeks (Q3W), pembrolizumab 10 mg/kg Q3W or docetaxel 75 mg/m2 Q3W. This study used an adaptive trial design so that the total number of participants randomized depended upon demonstration of sufficient objective responses at an interim analysis. Based on the positive outcome of the Overall Survival (OS) analysis, Protocol Amendment 12 (effective date: 09 Dec 2015) enabled eligible participants who were allocated to docetaxel and experienced disease progression, to be permitted to crossover to receive pembrolizumab 2 mg/kg Q3W as long as Inclusion/Exclusion criteria were met. These participants were participating in the Cross-Over Phase. The primary study hypotheses are that pembolizumab prolongs OS and Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by independent radiologists' review in previously-treated participants with NSCLC in the strongly positive programmed cell death ligand 1 (PD-L1) stratum compared to docetaxel and in participants whose tumors express PD-L1 compared to docetaxel.

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

Keywords

Non Small Cell Lung Cancer (NSCLC) PD1 PD-1 PDL1 PD-L1 Lung Neoplasms Carcinoma, Non-Small-Cell Lung Docetaxel Pembrolizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • Life expectancy of at least 3 months
  • Histologically- or cytologically-confirmed diagnosis of NSCLC that is anti-programmed cell death ligand 1 (PD-L1) positive per central laboratory review
  • At least one bi-dimensional measurable lesion
  • Radiographic progression after treatment with at least 2 cycles of a platinum-containing doublet
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

You CAN'T join if...

  • Prior therapy with docetaxel for NSCLC
  • Receiving systemic steroid therapy within 3 days prior to the first dose of study treatment or receiving any other form of immunosuppressive medication
  • Currently participating or has participated in a study using an investigational antineoplastic agent or device within 30 days of first dose
  • Expected to require any other form of systemic or localized antineoplastic therapy while on trial
  • History of allogeneic tissue/solid organ transplant
  • Prior systemic cytotoxic chemotherapy, antineoplastic biological therapy (e.g.,cetuximab), major surgery within 3 weeks of the first dose of study drug; received thoracic radiation therapy of >30 Gy within 6 months of the first dose of study drug;received prior tyrosine kinase inhibitor therapy or completed palliative radiotherapy within 7 days of the first dose of study drug
  • 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), or took part in another pembrolizumab trial
  • 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 requiring systemic steroids for treatment
  • Known history or active human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  • Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial through 120 days after last dose of pembrolizumab or 180 days after last dose of docetaxel

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Merck Sharp & Dohme Corp.
ID
NCT01905657
Phase
Phase 2/3
Lead Scientist
Matthew Gubens
Study Type
Interventional
Last Updated
September 6, 2017