Who is sponsoring NVALT10?

NVALT10 is sponsored by Dutch Society of Physicians for Pulmonology and Tuberculosis.

What condition does NVALT10 study?

NVALT10 studies Carcinoma, Non-Small-Cell Lung.

What drugs are being tested in NVALT10?

Interventions: erlotinib plus docetaxel or pemetrexed, erlotinib.

What is the status of NVALT10?

NVALT10 is currently COMPLETED.

Last reviewed 2020-09-25 · How we verify

A Randomized Phase II Study of Erlotinib Compared to Single Agent Chemotherapy-erlotinib Combination in Pretreated Patients With Advanced NSCLC (NVALT10 Study)

NCT00835471 Phase 2 COMPLETED

The purpose of this study is to assess if the combination of erlotinib and chemotherapy (docetaxel in case of squamous cell NSCLC or pemetrexed in case of other histological types) is superior to erlotinib alone and has acceptable tolerability and safety in the 2nd line treatment of patients with advanced/metastatic non-small cell lung cancer (NSCLC).

Details

Lead sponsor	Dutch Society of Physicians for Pulmonology and Tuberculosis
Phase	Phase 2
Status	COMPLETED
Enrolment	195
Start date	2009-03
Completion	2019-06

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

erlotinib plus docetaxel or pemetrexed
erlotinib

Primary outcomes

Progression Free Survival (PFS) — From randomisation to date of first progression or date of death, assessed up to 36 months
to compare the PFS in the group receiving erlotinib alone versus the patients receiving erlotinib + single agent Progression free survival

Countries

Netherlands