Ignite Creation Date:
2024-05-06 @ 8:36 AM
Last Modification Date:
2024-10-26 @ 12:02 PM
Study NCT ID:
NCT02775006
Status:
TERMINATED
Last Update Posted:
2019-04-30
First Post:
2016-04-12
Brief Title:
Docetaxel Versus Intercalated Erlotinib-docetaxel in Patients With Relapsed EGFR Wild Type ALK Negative Non Squamous Cell Carcinoma
Sponsor:
The Netherlands Cancer Institute
Organization:
The Netherlands Cancer Institute
Study Overview
Official Title:
A Randomized Phase III Study of Docetaxel Versus Intercalated Erlotinib Docetaxel Combination Therapy in Patients With Relapsed EGFR Epidermal Growth Factor Receptor Wild Type ALKAnaplastic Lymphoma Kinase Negative Non Squamous Cell Carcinoma NVALT 18 Study
Status:
TERMINATED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
accrual to slow target not achievable
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to investigate the effect of docetaxel monotherapy and the combination of docetaxel intercalated erlotinib in patients with relapsed EGFR wild type ALK negative non squamous cell carcinoma
Detailed Description:
The aim of this study is to investigate the effect of docetaxel monotherapy and the combination of docetaxel intercalated erlotinib in patients with relapsed EGFR wild type ALK negative non squamous cell carcinoma
As pemetrexed is standard first line treatment the combination of erlotinib docetaxel in non-squamous NSCLC should be investigated as second line treatment Also the question has to be answered whether the combination outperforms monotherapy treatments
After stratification for ECOG-performance status 0-1 response to prior treatment CR PR SD versus PD treatment free interval after platinum based therapy 6 months versus 6 months and maintenance patients will be centrally randomized to receive either docetaxel arm A or docetaxel plus erlotinib arm B
As pemetrexed is standard first line treatment the combination of erlotinib docetaxel in non-squamous NSCLC should be investigated as second line treatment Also the question has to be answered whether the combination outperforms monotherapy treatments
After stratification for ECOG-performance status 0-1 response to prior treatment CR PR SD versus PD treatment free interval after platinum based therapy 6 months versus 6 months and maintenance patients will be centrally randomized to receive either docetaxel arm A or docetaxel plus erlotinib arm B
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None