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)

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) - NVALT 18

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45166

Enrollment

230

Registered

2017-08-11

Start date

2016-10-14

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung cancer lung carcinoma

Interventions

Arm A: docetaxel 75mg/m2 every 21 days until disease progression or toxicity related. Arm B: docetaxel 75mg/m2 on day 1 plus erlotinib 150mg/day days 2-16, every 21 days, until disease progression,

docetaxel

erlotinib

locally advanced and metastatic

non-small cell lung cancer

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
To compare progression free survival between docetaxel and erlotinib-docetaxel in patients with relapsed EGFR wild type, ALK negative non squamous cell carcinoma patients.	—

Secondary

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

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)