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

Sponsor
The Netherlands Cancer Institute
Study ID
NCT02775006
Phase
PHASE3
Status
Terminated

Conditions

  • Carcinoma, Non-small Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Docetaxel — DRUG
    75mg/m2
  • Erlotinib — DRUG
    150mg/day

Study Details

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.

Key Dates

First listed
May 17, 2016
Start date
Oct 14, 2016
Status verified
Apr 2019
Primary completion
Apr 30, 2019
Completion
Apr 30, 2019

Study Design

Enrollment
45 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Docetaxel
    Docetaxel 75mg/m2 every 21 days until disease progression or toxicity related
  • Active Comparator: Docetaxel plus erlotinib
    Docetaxel 75mg/m2 on Day 1 plus erlotinib 150mg/day days 2-16, every 21 days, until disease progression, or toxicity related.

Primary Outcome Measure

progression free survival [ Time Frame: from the date of randomization to the first date of progression of disease or of death from any cause up to 24 months after last treatment administration ]

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