NCT02775006

Docetaxel Versus Intercalated Erlotinib-docetaxel in Patients With Relapsed EGFR Wild Type, ALK Negative Non Squamous Cell Carcinoma

A Randomized Phase III Study of Docetaxel Versus Intercalated Erlotinib Docetaxel Combination Therapy in Patients With Relapsed EGFR (Epidermal Growth Factor Receptor) Wild Type, ALK(Anaplastic Lymphoma Kinase) Negative Non Squamous Cell Carcinoma. (NVALT 18 Study)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Carcinoma, Non-small Cell Lung

Interventions

Type	Name	Description
DRUG	Docetaxel	75mg/m2
DRUG	Erlotinib	150mg/day

Timeline

• Start date: 2016-10-14
• Primary completion: 2019-04-01
• Completion: 2019-04-01
• First posted: 2016-05-17
• Last updated: 2019-04-30

Locations

19 sites across 1 country: Netherlands