Lung, Carcinoma Clinical Trial
Official title:
A Multi-center, Open-labeled Phase 2 Study of First Line Intermittent and Maintenance of Erlotinib in Combination With Pemetrexed/Carboplatin in ⅢB/IV Non Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation
EGFR-tyrosine kinase inhibitor(TKI)- ie, erlotinib, gefitinib, has been recommended as the
first option for EGFR-mutated IIIb/IV NSCLC by serial trials as it prolonged patients'
progression-free survival. The OPTIMAl trial indicated that those who received TKI and
chemotherapy during the whole treatment window survived longest. Unfortunately, previous
studies(INTACT, TRIBUTE et al) that concurrently combined TKI and cytotoxic regimens failed
to improve survival in unselected patients. To avoid the potential synergistic antagonism,
the FAST-ACT II trial committed a sequential strategy and find a superiority in the
combination arm upon chemotherapy even in EGFR-mutated group. However, pharmaceutically, the
continuous administration of an EGFR-TKI before subsequent chemotherapy in FAST-ACT II could
obviate the effects of cytotoxic agents due to the erlotinib-induced G1 arrest.
On the basis of these and other studies, the investigators hypothesized that a better
sequential combination strategy of EGFR-TKI and chemotherapy (adding a EGFR-TKI wash-out
window before chemotherapy) would be more efficacious than chemotherapy alone. In this
study, the investigators investigate the efficacy(PFS:progression free survival), safety,
and adverse-event profile of chemotherapy plus intermittent and maintenance of erlotinib,
when these drugs were used as first-line treatment in who had non-squamous lung carcinoma
with EGFR gene mutation in China.
n/a
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02139579 -
Efficacy and Safety Study of Bevacizumab Plus Chemotherapy in EGFR-TKI Resistant Non-Squamous Non-Small Cell Lung Cancer
|
Phase 2 | |
| Not yet recruiting |
NCT03151161 -
Intermittent and Maintenance of Icotinib in Combination With Pemetrexed/Carboplatin Compared With Icotinib Single Drug in Ⅲb/IV Non Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation
|
Phase 2 |