A randomized phase III study of monotherapy docetaxel or intercalated erlotinib docetaxel combination therapy in patients with relapsed EGFR wild type, ALK negative non squamous cell carcinoma. (NVALT 18 study)<br>

Phase 3

Completed

• Conditions: lung cancer; lung carcinoma; 10038666

• Registration Number: NL-OMON45166
• Lead Sponsor: Stichting NVALT studies

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 230

Inclusion Criteria

1. Histologically or cytologically confirmed EGFR wild type, ALK negative, non squamous cell carcinoma, locally advanced and metastatic disease stage IIIB and IV. Evidence of disease progression after one cytotoxic treatment platinum containing regimen or immunotherapy.
2. ECOG PS 0-1.
3. Age > 18 years.

Exclusion Criteria

1. Patients with medical risks because of non-malignant disease as well as those with active uncontrolled infection.
2. Concomitant treatment with any other experimental drug under investigation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To compare progression free survival between docetaxel and erlotinib-docetaxel<br /><br>in patients with relapsed EGFR wild type, ALK negative non squamous cell<br /><br>carcinoma patients.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To characterize the quantitative and qualitative toxicities of these regimens,<br /><br>response rates and duration of response for responding patients, and survival.<br /><br>In addition, pharmacokinetic parameters will be studied for both drugs, thereby<br /><br>studying the influence these drugs on each others exposure and the influence of<br /><br>genetic and environmental factors in individual patients.</p><br>