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

April 26, 2019 updated by: The Netherlands Cancer Institute

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Apeldoorn, Netherlands
        • Gelre Ziekenhuis
      • Breda, Netherlands
        • Amphia Hospital
      • Den Bosch, Netherlands
        • Jeroen Bosch Hospital
      • Den Haag, Netherlands, 2545 CH
        • Haga
      • Dordrecht, Netherlands
        • Albert Schweitzer Ziekenhuis
      • Ede, Netherlands
        • Ziekenhuis Gelderse Vallei
      • Eindhoven, Netherlands, 5631 BM
        • Máxima Medisch Centrum
      • Groningen, Netherlands
        • Martini Ziekenhuis
      • Hoofddorp, Netherlands, 2130 AT
        • Spaarne Gasthuis
      • Leeuwarden, Netherlands, 8934 AD
        • MCL
      • Maastricht, Netherlands
        • Maastricht University Medical Center
      • Roermond, Netherlands
        • Laurentius Hospital
      • Rotterdam, Netherlands
        • Erasmus MC
      • Rotterdam, Netherlands, 3045 PM
        • St. Fransicus Gasthuis
      • Rotterdam, Netherlands, 3083 AN
        • Ikazia
      • Utrecht, Netherlands
        • St. Antonius Ziekenhuis
      • Venlo, Netherlands
        • VieCuri Medisch Centrum voor Noord-Limburg
      • the Hague, Netherlands
        • Medical Center Haaglanden
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1081HV
        • VUmc Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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. Immunotherapy pretreatment is allowed
  2. Complete recovery from prior chemotherapy side effects to < Grade 2.
  3. At least one unidimensionally measurable lesion meeting RECIST criteria.
  4. ECOG PS 0-1.
  5. Age ≥ 18 years.

  6. Adequate organ function, including:

    • Adequate bone marrow reserve: ANC > 1.5 x 109/L, platelets ≥ 100 x 109/L.
    • Hepatic: bilirubin ≤1.5 x ULN (upper limit normal), AP, ALT, AST ≤ 1.5 x ULN. AP, ALT, and AST ≤5 x ULN is acceptable if the liver has tumor involvement.
    • Renal: calculated creatinine clearance ≥ 40 ml/min based on the Cockcroft-Gault formula.
  7. Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate. Female patients with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
  8. Signed informed consent.
  9. Patient compliance and geographical proximity that allow adequate follow up.
  10. Patients who have undergone cranial irradiation for brain metastases more than 4 weeks before inclusion in our protocol, provided that they are clinically fit to undergo second line treatment

Exclusion Criteria:

  1. Pregnant or lactating women.
  2. Patients with medical risks because of non-malignant disease as well as those with active uncontrolled infection.
  3. Documented brain metastases unless the patient has completed local therapy for central nervous system metastases at least 4 weeks before enrollment and has been off corticosteroids for at least two weeks before enrollment. Prophylactic irradiation at least 4 weeks prior to enrollment is accepted.
  4. Maintenance treatment with erlotinib or other TKI (Tyrosine Kinase Inhibitor), or docetaxel. Maintenance treatment with pemetrexed is allowed. Previous treatment with an EGFR-TKI or docetaxel within 6 months prior to enrollment.
  5. Inability or unwillingness to take dexamethasone.
  6. Concomitant treatment with any other experimental drug under investigation.
  7. Patients experiencing disease progression within 2 months after the start of platinum based chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Docetaxel
Docetaxel 75mg/m2 every 21 days until disease progression or toxicity related
Drug: Docetaxel
75mg/m2
Other Names:
  • Taxotere
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.
Drug: Docetaxel
75mg/m2
Other Names:
  • Taxotere
Drug: Erlotinib
150mg/day
Other Names:
  • Tarceva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quantitative and qualitative adverse events
Time Frame: from the date of randomization until resolution or stabilization of the event and up to 30 days after the last study medication/treatment
Adverse events will be graded according to NCI Common Toxicity Criteria version 4.03
from the date of randomization until resolution or stabilization of the event and up to 30 days after the last study medication/treatment
response rates
Time Frame: Every six weeks from date of randomization until the date of first documented progression or date of death from any cause up to 24 months after last treatment administration
Every six weeks from date of randomization until the date of first documented progression or date of death from any cause up to 24 months after last treatment administration
duration of response
Time Frame: from the date of the first objective status assessment of a complete or partial response to the first date of progression of disease or death from any cause up to 24 months after last treatment administration
from the date of the first objective status assessment of a complete or partial response to the first date of progression of disease or death from any cause up to 24 months after last treatment administration
overall survival
Time Frame: from the date of randomization to the date of death from any cause up to 24 months after last treatment administration
Evaluation of overall survival (OS)
from the date of randomization to the date of death from any cause up to 24 months after last treatment administration

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Erlotinib dose level variance in blood
Time Frame: Every six weeks from randomisation up until last treatment administration (up until 48 weeks)
Therefore in patients on erlotinib every 6 weeks through dose levels in blood will be determined
Every six weeks from randomisation up until last treatment administration (up until 48 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Netherlands Cancer Institute

Collaborators

Dutch Society of Physicians for Pulmonology and Tuberculosis

Investigators

  • Principal Investigator: Joachim G Aerts, MD PhD, Dutch Society of Physicians for Pulmonology and Tuberculosis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2016

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

April 12, 2016

First Submitted That Met QC Criteria

May 12, 2016

First Posted (Estimate)

May 17, 2016

Study Record Updates

Last Update Posted (Actual)

April 30, 2019

Last Update Submitted That Met QC Criteria

April 26, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NVALT 18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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