Clinical Trials Logo
  1. Home
  2. Carcinoma, Non-Small-Cell Lung
  3. NCT04487080

A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer — MARIPOSA  

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:
A Phase 3, Randomized Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib Versus Lazertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer.

Clinical Trial Summary

The purpose of this study is to assess the efficacy of the amivantamab and lazertinib combination, compared with osimertinib, in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions [Exon 19del] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).

Clinical Trial Description

Worldwide, lung cancer is the most commonly diagnosed cancer. In NSCLC the most prevalent actionable driver mutations result in the activation of epidermal growth factor receptor (EGFR). Osimertinib and Lazertinib are EGFR tyrosine kinase inhibitors (TKIs). Amivantamab is a novel bispecific antibody that targets the extracellular domain of both EGFR and MET and can inhibit tumor growth driven by EGFR and mesenchymal-epithelial transition (MET) receptors. Lazertinib inhibits primary activating Exon 19dell and Exon 21 L858R substitution EGFR mutations, and the EGFR T790M+ resistance mutation. The hypothesis is that the amivantamab and lazertinib combination (Arm A) will demonstrate superior PFS compared with single-agent osimertinib (Arm B). The study consists of 3 phases: Screening Phase, Treatment Phase and Follow-up Phase. Participants will undergo response evaluation criteria in solid tumors (RECIST 1.1), pharmacokinetics, and safety evaluations (adverse events, laboratory tests, vital sign measurements, physical examinations). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04487080
Study type Interventional
Source Janssen Research & Development, LLC
Contact
Status Active, not recruiting
Phase Phase 3
Start date September 30, 2020
Completion date June 9, 2027
View Details
See also
  Status Clinical Trial Phase
Completed NCT04879849 - A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers Phase 1
Completed NCT04426825 - A Study of Atezolizumab in Combination With Bevacizumab in Patients With EGFR Mutation Positive Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer Phase 2
Terminated NCT03166631 - A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread Phase 1
Completed NCT02864394 - Study of Pembrolizumab Versus Docetaxel in Participants Previously Treated for Non-Small Cell Lung Cancer (MK-3475-033/KEYNOTE-033) Phase 3
Completed NCT02810457 - Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer Phase 3
Recruiting NCT04592523 - A Study of Usage of Brigatinib in the Treatment of Adult Participants for Approved Indications In South Korea
Recruiting NCT04838548 - A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With EGFR-Positive Advanced Non-Small Cell Lung Cancer Phase 2
Recruiting NCT04077463 - A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer Phase 1
Recruiting NCT04603807 - A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases Phase 3
Recruiting NCT05167604 - Clinical Value of MRD Monitoring for Adjuvant Therapy in Postoperative NSCLC
Completed NCT04948411 - Durvalumab as Maintenance in Patients Who Received Chemoradiotherapy for Unresectable Stage III NSCLC: Real World Data From an Expanded Access Program in Brazil
Not yet recruiting NCT04255836 - Durvalumab Combined With Chemotherapy and Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Non-small Cell Lung Cancer (NSCLC) Phase 2
Completed NCT01953913 - Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation Phase 3
Recruiting NCT05715229 - Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy Phase 2
Recruiting NCT04931654 - A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer Phase 1/Phase 2
Suspended NCT05421936 - Osimertinib for NSCLC With Uncommon EGFR Mutations
Completed NCT02847377 - A Positron Emission Tomography (PET) Imaging Agent [18F]-ODS2004436 as a Marker of EGFR Mutation in Subjects With NSCLC N/A
Completed NCT04427072 - Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation Phase 3
Recruiting NCT04823377 - Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer. N/A
Completed NCT04452214 - A Study of the Safety and Tolerance of CAN04 and Pembrolizumab in Combination With and Without Carboplatin and Pemetrexed in Subjects With Solid Tumors Phase 1