Non Small Cell Lung Cancer Clinical Trial
Official title:
Phase I, Open-label, Safety, Tolerability and Preliminary Efficacy Study of Tremelimumab in Combination With Gefitinib in EGFR Mutant NSCLC Patients
This is an open-label phase 1, safety, PK, and preliminary efficacy study of oral Gefitinib
and IV Tremelimumab in previously treated NSCLC patients who have documented evidence of an
activating mutation in the EGFR gene and have failed treatment with an EGFR inhibitor such
as Erlotinib or Gefitinib. The primary objective of this phase I, is to determine the safety
and tolerability of oral Gefitinib in combination with escalating doses of Tremelimumab and
to establish a recommended phase 2 dose. Secondary objectives include evaluation of,
pharmacokinetics, immunogenicity, antitumor activity of Gefitinib and Tremelimumab
combination. The exploratory objectives are to evaluate biomarkers that may correlate with
activity or prospectively identify patients likely to respond to Tremelimumab and Gefitinib.
The biological rationale for such a study is that even though the disease is progressing it
is likely that EGFR sensitive clones, although diminished under the pressure from the EGFR
TKI, are still present. Therefore, withdrawing the inhibitory pressure of the EGFR TKI can
potentially allow regrowth of the EGFR sensitive cells. On the other hand, the proliferation
of EGFR resistant clones needs to be suppressed by another therapeutic approach. Until today
no association of chemotherapy and TKI EGFR has demonstrated clinical benefit. Moreover,
patients may have received chemotherapy and the likelihood of chemosensitivity is very low.
So, the association of Gefitinib with immune checkpoint blockade is very attractive and may
result in clinical benefit in NSCLC with EGFRmut.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
Recruiting |
NCT05707286 -
Pilot Study to Determine Pro-Inflammatory Cytokine Kinetics During Immune Checkpoint Inhibitor Therapy
|
||
Recruiting |
NCT04258137 -
Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study
|
N/A | |
Completed |
NCT01945021 -
Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC
|
Phase 2 | |
Completed |
NCT04487457 -
Prospective Study to Evaluate the Blood Kinetics of Immune Cells and Immunosuppressive Cytokines After Exposure to an Immunity Checkpoint Inhibitor (ICI): Study of the Impact of Chemotherapy
|
||
Terminated |
NCT04022876 -
A Study of ALRN-6924 for the Prevention of Chemotherapy-induced Side Effects (Chemoprotection)
|
Phase 1 | |
Recruiting |
NCT05898763 -
TEIPP Immunotherapy in Patients With NSCLC
|
Phase 1/Phase 2 | |
Recruiting |
NCT05532696 -
Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients
|
Phase 1/Phase 2 | |
Completed |
NCT04311034 -
A Study of RC48-ADC in Subjects With Advanced Non-small Cell Lung Cancer
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03177291 -
Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC
|
Phase 1 | |
Terminated |
NCT03257722 -
Pembrolizumab + Idelalisib for Lung Cancer Study
|
Phase 1/Phase 2 | |
Completed |
NCT00349089 -
Trial on Refinement of Early Stage Lung Cancer Adjuvant Therapy
|
Phase 2 | |
Completed |
NCT05116891 -
A Phase 1/2 Study of CAN04 in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04571632 -
Clinical Trial of SBRT and Systemic Pembrolizumab With or Without Avelumab/Ipilimumab+ Dendritic Cells in Solid Tumors
|
Phase 2 | |
Terminated |
NCT03599518 -
DS-1205c With Gefitinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer
|
Phase 1 | |
Not yet recruiting |
NCT06020989 -
Lazertinib and Chemotherapy Combination in EGFR-mutant NSCLC Patients Without ctDNA Clearance After lead-in Lazertinib Monotherapy
|
Phase 2 | |
Withdrawn |
NCT03982134 -
PDR001 + Panobinostat for Melanoma and NSCLC
|
Phase 1 | |
Withdrawn |
NCT03574649 -
QUILT-2.024: Phase 2 Neoadjuvant, Consolidation, and Adjuvant Combination NANT Immunotherapy Versus Standard of Care in Subjects With Resectable Non-small Cell Lung Cancer
|
Phase 2 | |
Withdrawn |
NCT02844140 -
DE-CT in Lung Cancer Proton Therapy
|
N/A | |
Completed |
NCT03780010 -
Study of TRC105 + Paclitaxel/Carboplatin and Bevacizumab in Patients With NSCLC
|
Phase 1 |