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
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