Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

Summary

The purpose of this study is to identify the recommended Phase 2 combination dose (RP2CD[s]) of the amivantamab and capmatinib combination therapy in participants with non-small cell lung cancer (NSCLC) in Phase 1 (combination dose selection), and to evaluate the antitumor effect of the amivantamab and capmatinib combination therapy in mesenchymal-epithelial transition (MET) exon 14 skipping mutation and MET amplified NSCLC, when administered at the selected RP2CD(s) in Phase 2 (expansion).

Official Title

A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer

Details

Lung cancer is one of the most frequently diagnosed cancers and the leading cause of cancer related deaths worldwide. It is a heterogenous disease and is broadly classified as non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC). This study will combine the 2 mesenchymal-epithelial transition (MET) inhibitors, amivantamab and capmatinib, which have different mechanisms of MET inhibition and, as monotherapies, have demonstrated clinical activity in MET driven NSCLC. Amivantamab is a bispecific antibody that targets both the epidermal growth factor receptor (EGFR) and MET extracellular ligand binding domains and inhibits ligand driven signaling. Capmatinib is a selective, oral MET tyrosine kinase inhibitor (TKI) that inhibits the MET downstream signaling pathway and thereby inhibits tumor growth and progression. The primary hypothesis of the study is that amivantamab and capmatinib can be safely administered as a combination therapy, with a tolerable safety profile (Phase 1), and the combination of amivantamab and capmatinib will demonstrate clinically significant anti-tumor activity for participants with NSCLC harboring MET exon 14 skipping mutations or MET amplification (Phase 2). The study will include a screening period, a treatment period , and a post-treatment follow-up period. The overall duration of the study will be up to 2 years 1 month.

Keywords

Carcinoma, Non-Small-Cell Lung Amivantamab-vmjw Capmatinib Amivantamab

Eligibility

You can join if…

Open to people ages 18 years and up

  • Previously diagnosed with histologically or cytologically confirmed unresectable Stage IV (metastatic) non-small cell lung cancer (NSCLC) (any histology)
  • May have: definitively, locally treated brain metastases that are clinically stable and asymptomatic for greater than (>) 2 weeks and who are off or receiving low-dose corticosteroid treatment (less than or equal to [<=]10 milligrams (mg) prednisone or equivalent) for at least 2 weeks prior to start of study treatment
  • May have a prior malignancy (other than the disease under study) the natural history or treatment of which is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • A female participant of childbearing potential must have a negative serum pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study

You CAN'T join if...

  • Medical history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
  • Participant has impairment of the gastrointestinal function that could affect absorption of capmatinib or is unable or unwilling to swallow tablets
  • Participant has symptomatic central nervous system (CNS) metastases which are neurologically unstable or have required increasing doses of steroids >10 mg prednisone or equivalent within the 2 weeks prior to study entry to manage CNS symptoms
  • Participant has uncontrolled tumor-related pain: Symptomatic lesions amenable to palliative radiotherapy (example, bone metastases, or metastases causing nerve impingement) should be treated more than 7 days prior to the administration of the first study treatment

Locations

  • University of California, Irvine
    Orange California 92868 United States
  • The Oncology Institute of Hope and Innovation
    Whittier California 90603 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT05488314
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 147 study participants
Last Updated