Carcinoma, Non-Small-Cell Lung Clinical Trial
Official title:
Exploratory Phase 0/1 of Positron Emission Tomography (PET) Imaging Agent [18F]-ODS2004436 as a Marker of EGFR Mutation in Subjects With NSCLC
The development of biomarkers will lead the dynamic of personalized medicine and fill the
unsatisfied needs in oncology for prediction of therapeutic response.
Molecular imaging enables non invasive quantification of biomarkers. The development of
molecular imaging biomarkers is closely related to the development of therapeutic molecules.
Among the potential targets, kinases offer a lot of advantages: (i) they play a central role
in cellular regulation, (ii) numerous kinase-specific small molecule libraries exist in
biotech and pharma industry, (iii) several kinase-targeted therapies are used in clinic
(imatinib, sorafenib, sunitinib…) with application across a variety of therapeutic
indications. Among the imaging technologies, the Positron Emission Tomography (PET) is the
most sensitive and dedicated to evaluate small molecules. However few radiotracers are
available and their specificity limits their clinical use. The IMAkinib® approach is an
innovative method proposed to develop new PET radiotracers adapted to current medical and
economical challenges.
The epidermal growth factor receptor (EGFR) is an established target for the treatment of
advanced non-small cell lung cancer (NSCLC). The EGFR tyrosine kinase inhibitors (TKIs)
Gefitinib (Iressa®), erlotinib (Tarceva®) and afatinib (Giotrif®) have already been approved
for treatment of NSCLC harboring EGFR activating mutations (L858R or del exon 19).
Unfortunately the majority of patients will develop a resistance to the TKI in the long term
(6-12 months). If the mechanism of resistance is not yet fully characterized, most patients
(50%) will acquire an additional T790M mutation of EGFR. TKI PET-imaging can provide a tool
to determine and predict responsiveness to EGFR TKI in vivo. That is why, the investigators
have selected and radiolabeled (18-Fluor) a compound targeting specifically EGFR mutated
([18F]-ODS2004436) which was further evaluated in a preclinical imaging study to determine
the feasibility of TKI-PET. The investigators proved in vivo that [18F]-ODS2004436 a compound
is a good candidate to evaluate the EGFR activity in human lung tumours using PET imaging.
n/a
| 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 |
NCT02810457 -
Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer
|
Phase 3 | |
| Completed |
NCT02864394 -
Study of Pembrolizumab Versus Docetaxel in Participants Previously Treated for Non-Small Cell Lung Cancer (MK-3475-033/KEYNOTE-033)
|
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
|
||
| Active, not recruiting |
NCT04487080 -
A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
|
Phase 3 | |
| 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 |
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 |