A Study of Amivantamab (JNJ-61186372) Among Participants With Advanced NSCLC Harboring ALK, ROS1, and RET Gene Fusions in Combination With Tyrosine Kinase Inhibitors (TKIs)

Inclusion criteria: Participant has locally advanced (unresectable) or metastatic NSCLC with a known RET fusion. Participants must have clinical progression on at least one prior RET therapy. They must be on a RET inhibitor at the same dose for at least 3 months prior to enrolling on this study. RET inhibitors that will be considered include but not limited to selpercatinib and pralsetinib. The patient cannot have received an EGFR TKI (e.g. osimertinib, afatinib), EGFR-directed monoclonal antibody (e.g. cetuximab), MET-inhibitor (e.g., tepotinib, capmatinib, telisotuzumab vedotin, etc.) at any point prior to study entry.

Sponsor/Collaborator: University of Colorado, Denver and Janssen Research & Development, LLC

Contact and Locations:
Study contact: Principal Investigator: Tejas Patil Febin Elias
Phone: 303-724-9459
Email: febin.elias@cuanschutz.edu
Locations: Colorado Research Center, Colorado Outpatient CTRC, UCHealth Metro Denver, University of Michigan Rogel Cancer Center

Mechanism of action: In many of these cases, increased activation of the (epidermal growth factor receptor (ERBB) or mesenchymal-epithelial transition (cMet) pathways appears to be a bypass signaling mechanism that allows cancer cells to circumvent the selective pressure from RET TKIs. Amivantamab is a bispecific antibody that binds to the extracellular domains of EGFR and MET.

Phases: Phase 1, Phase 2

NCT Number: NCT05845671

URL: https://classic.clinicaltrials.gov/ct2/show/NCT05845671

Status: Recruiting

A study testing a the anti-TROP2 antibody-drug conjugate sacituzumab tirumotecan (MK-2870) versus chemotherapy in previously treated non-small cell lung cancer (NSCLC) with genomic alterations including RET

Inclusion criteria: Metastatic non-squamous NSCLC with RET alterations. Documentation of locally assessed radiological disease progression while on or after last treatment.

Sponsor/Collaborator: Merck Sharp & Dohme LLC

Contact and Locations:
Study email: Trialsites@msd.com
Phone Number: 1-888-577-8839
Locations (U.S. and outside the U.S.): https://clinicaltrials.gov/study/NCT06074588#study-overview

Mechanism of action: Sacituzumab tirumotecan is an investigational trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC).

Phases: Phase 3

NCT Number: NCT06074588

URL: https://clinicaltrials.gov/study/NCT06074588#study-overview

Status: Recruiting

A Study of EP0031-101 in Patients With Advanced RET-altered Malignancies

Inclusion criteria: Advanced Solid Tumor. Patients with RET-altered tumors who have progressed following first-generation selective RET inhibitor (SRI) therapy and patients with RET-altered tumors with no prior SRI therapy.

Sponsor/Collaborator: Ellipses Pharma

Contact and Locations:
Study Contact: Sonia Serrano
Phone Number: +44 (0)20 3743 0992
Email: sonia@ellipses.life
Locations: https://clinicaltrials.gov/study/NCT05443126#contacts-and-locations

Mechanism of action: EP0031 selectively binds to various RET fusions and mutations, including solvent front resistance mutations.

Phases: Phase 1, Phase 2

NCT Number: NCT05443126

URL: https://clinicaltrials.gov/study/NCT05443126

Status: Recruiting

A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)

Inclusion criteria: The reason for this study is to see if the study drug, selpercatinib, compared to placebo is effective and safe in delaying cancer return in participants with early-stage non-small cell lung cancer (NSCLC), who have already had surgery or radiation.

Sponsor/Collaborator: Loxo Oncology, Inc.|Eli Lilly and Company

Contact and Locations:
There may be multiple sites in this clinical trial
Email: ClinicalTrials.gov@lilly.com
Phone Number: 1-877-CTLILLY (1-877-285-4559)
Locations: https://clinicaltrials.gov/study/NCT04819100#contacts-and-locations

Mechanism of action: Selpercatinib, also known as LOXO-292, is a highly selective and potent, oral inhibitor for the treatment of patients with cancers that harbor abnormalities in the RET kinase

Phases: Phase 3

NCT Number: NCT04819100

URL: https://clinicaltrials.gov/study/NCT04819100

Status: Recruiting

 A Study of Multiple Therapies in Biomarker-Selected Patients With Resectable Stages IB-III Non-Small Cell Lung Cancer

Inclusion criteria: This trial will evaluate the efficacy and safety of various therapies in patients with Stage IB, IIA, IIB, IIIA, or selected IIIB resectable and untreated RET positive non-small cell lung cancer (NSCLC).

Sponsor/Collaborator: Genentech, Inc.|Blueprint Medicines Corporation|Chugai Pharmaceutical Co.|Hoffmann-La Roche

Contact and Locations:
Reference Study ID Number: ML41591
Email: global-roche-genentech-trials@gene.com
Phone Number: 888-662-6728
Locations: https://clinicaltrials.gov/study/NCT04302025#contacts-and-locations

Mechanism of action: Pralsetinib is a highly potent, selective RET inhibitor for the treatment of patients with cancers that harbor abnormalities in the RET kinase.

Phases: Phase 2

NCT Number: NCT04302025

URL: https://clinicaltrials.gov/study/NCT04302025

Status: Recruiting

Cabozantinib in Patients With RET Fusion-Positive Advanced Non-Small Cell Lung Cancer or Increased MET or AXL Activity

Inclusion criteria: The purpose of this phase II study is to find out what effects cabozantinib (XL184) has, good and/or bad, in patients whose tumors one of the following gene changes RET, ROS1, or NTRK fusion, or increased MET or AXL activity.

Sponsor/Collaborator: Memorial Sloan Kettering Cancer Center|Exelixis

Contact and Locations:
Study contact: Alexander Drilon, MD
Phone Number: 646-888-4206
Locations: https://clinicaltrials.gov/study/NCT01639508#contacts-and-locations

Mechanism of action: Cabozantinib is an oral medicine that inhibits of RET, ROS1, NTRK, MET, and AXL. In many of these cases, increased activation of the mesenchymal-epithelial transition (cMet) pathway appears to be a bypass signaling mechanism that allows cancer cells to circumvent the selective pressure from RET inhibitors.

Phases: Phase 2

NCT Number: NCT01639508

URL: https://clinicaltrials.gov/study/NCT01639508

Status: Recruiting

Real Word European Registry of NTRK Fusions and Other Rare Actionable Fusions (TRacKING)

Inclusion criteria: This registry will make it possible to describe real life management of patients with rare actionable fusions (including RET) and to better understand these cancers. In addition of clinical data from the medical files, a quality of life questionnaire (QLQ-C30) will be complete at inclusion, at each new treatment and then every 6 months. The patients will be followed for a period of at least 2 years after the inclusion.

Sponsor/Collaborator: Centre Leon Berard

Contact and Locations: 
Name: Julien Bollard
Phone Number: 04 78 78 28 28
Email: julien.bollard@lyon.unicancer.fr

Phases: Observational

NCT Number: NCT04921553

URL: https://classic.clinicaltrials.gov/ct2/show/NCT05653869

Status: Recruiting

Epidemiology of Young Lung Cancer Study (Participants needed)

Inclusion criteria: This study is open to adults who were diagnosed with lung cancer before age 50 and have completed comprehensive biomarker testing. Only individuals who live in the United States are eligible.

Sponsor/Collaborator: Dr. Jorge J. Nieva, ALCMI, GO2

Contact and Locations: 
Dr. Jorge J. Nieva, associate professor of clinical medicine at the University of Southern California’s Keck School of Medicine in Los Angeles.
ALCMI and GO
Phone: 888-44-EOYLC (888-443-6952)
https://happylungsproject.org/study-epidemiology-of-young-lung-cancer-study/

URL: https://alcmi.org/research/eoylc/

A Study of LP-300 With Carboplatin and Pemetrexed in Never Smokers With Advanced Lung Adenocarcinoma (HARMONIC)

Inclusion criteria: The goal of this clinical trial is to determine clinical advantages for LP-300 in combination with carboplatin and pemetrexed in the never smoker patient population Patients who are never smokers with lung adenocarcinoma and have relapsed after treatment with tyrosine kinase inhibitors (TKIs) will be eligible for enrollment.

Sponsor/Collaborator: Lantern Pharma Inc

Contact and Locations: 
https://www.harmonictrial.com/
Name: Ernest Kitt
Phone Number: 972-277-1136
Email: ekitt@lanternpharma.com

Mechanism of action: LP-300, works together with chemotherapy by interacting in the TK gene pathways, interrupting their activity to slow or prevent tumor growth and spread.

Phases: Phase 2

NCT Number: NCT05456256

URL: https://clinicaltrials.gov/study/NCT05456256

Status: Recruiting