LUNG: NSCLC: METASTATIC: Non-squamous: 1st Line: LEAP-006

A Phase 3 Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First-line Intervention in Participants With Metastatic Nonsquamous Non-small Cell Lung Cancer (LEAP-006)

Title
Merck MK-7902-006 Lung LEAP 006
Study Title

A Phase 3 Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First-line Intervention in Participants With Metastatic Nonsquamous Non-small Cell Lung Cancer (LEAP-006)

Site Link
Malignancy
Lung cancer, Non-small cell lung cancer, NSCLC
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
1st Line
Investigational Agent
Lenvatinib and Pembrolizumab
Drug Class
VGFR antibody, PD-1 antibody
PI
Ari VanderWalde, MD
Sponsor
Merck Sharp & Dohme Corp
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Histologically or cytologically confirmed metastatic nonsquamous NSCLC
  • EGFR wt, ALK-wt, ROS1-wt
  • Measurable disease per RECIST 1.1
  • ECOG PS 0-1
  • Adequately controlled BP defined as BP <150/90 with no change in antihypertensive meds within 1 week prior to randomization
  • No known untreated CNS mets
  • No history of pneumonitis that required steroids
  • No major blood vessel invastion or large volume hemoptysis
  • No known HIV/HBV/HCV
  • No active autoimmune disease
  • No prior hypersensitivity to monoclonal antibodies
Objective
  • Primary- PFS and OS
  • Secondary- ORR, DoR, safety, QoL
Assessment Frequency
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Assessment Frequency 2
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Assessment Frequency Link
Path
Adenocarcinoma, large-cell carcinoma, broncho-alveolar carcinoma
Dosing Frequency
Control Agents
Study Protocol
Randomized
Yes
X