Trial Information

A Phase Ⅱ Randomized Controlled Trial to Compare Chemotherapy Sequenced by EGFR-TKIs and Chemotherapy Combined With EGFR-TKIs for Advanced or Metastatic NSCLC Patients Failed to EGFR-TKIs Therapy

Responses to EGFR-TKIs are quiet dramatic and durable, especially in patients with EGFR gene
classic mutations, such as 19 deletion or 21 leucine 858 arginine(L858R). However, most
patients with NSCLC who respond to EGFR-TKIs eventually experience progression of disease
after approximately 12 months. The lack of an established therapeutic option for NSCLC
patients who have progressive disease after EGFR-TKIs failure poses a great challenge to
physicians in terms of how best to manage this growing group of lung cancer patients.

In clinical practice some of the initially EGFR-TKI sensitive tumors which progressed
evidence a striking increase in tumor volume within several weeks, after being taken off
EGFR-TKI. This response is called "rebound phenomenon". Most experts still believe that
these tumors continue to be "oncogene-addicted" to EGFR. So it is rational that EGFR-TKI
combined with another chemotherapy regimen can be used to treat NSCLC after the failure of
EGFR-TKI therapy.

However in some phase Ⅱclinical trials involved a few NSCLC patients who failed to EGFR-TKI
therapy, another treatment mode, that is to say, at least one cytotoxic chemotherapy was
used firstly then switched to EGFR-TKI therapy until progression of disease, was used and
called reintroduction or retreatment of EGFR-TKI. Using this treatment mode, some
investigators reported the partial remission (PR) and disease control rate (DCR) were
observed in 21.7%-36% and 65.2%-86% NSCLC patients.