2nd Line Erlotinib Treatment With (Out) Chemotherapy of Advanced Non Small Cell Lung Cancer (NSCLC) (NVALT10)

September 25, 2020 updated by: Dutch Society of Physicians for Pulmonology and Tuberculosis

A Randomized Phase II Study of Erlotinib Compared to Single Agent Chemotherapy-erlotinib Combination in Pretreated Patients With Advanced NSCLC (NVALT10 Study)

The purpose of this study is to assess if the combination of erlotinib and chemotherapy (docetaxel in case of squamous cell NSCLC or pemetrexed in case of other histological types) is superior to erlotinib alone and has acceptable tolerability and safety in the 2nd line treatment of patients with advanced/metastatic non-small cell lung cancer (NSCLC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Open randomized multicenter phase II study in patients in need of 2nd line treatment for advanced/metastatic NSCLC. Efficacy and safety of monotherapy with erlotinib will be compared with combination therapy of erlotinib and chemotherapy. In recent studies it was established that pemetrexed activity is more pronounced in non-squamous NSCLC in comparison to squamous cell carcinoma. Therefore in patients with non-squamous carcinoma pemetrexed will be used. As in second line treatment of NSCLC docetaxel is registered also for usage in patients with squamous cell carcinoma, docetaxel will be used in patients with squamous histology.

Chemotherapy will be limited to 4 courses. Erlotinib will be continued until disease progression or unacceptable toxicity.

Erlotinib as monotherapy will be administered continuously. In combination with chemotherapy, erlotinib will be given from day 2-16 of every course of 3 weeks.

Study Type

Interventional

Enrollment (Actual)

195

Phase

  • Phase 2

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
      • Amsterdam, Netherlands
        • VU Medisch Centrum
      • Beverwijk, Netherlands
        • Rode Kruis Ziekenhuis
      • Breda, Netherlands
        • Amphia Ziekenhuis
      • Delft, Netherlands
        • Reinier de Graaf Gasthuis
      • Den Bosch, Netherlands
        • Jeroen Bosch Ziekenhuis
      • Eindhoven, Netherlands
        • Catharina-ziekenhuis
      • Groningen, Netherlands
        • Martini Ziekenhuis
      • Haarlem, Netherlands
        • Kennemer Gasthuis
      • Maastricht, Netherlands
        • Academisch Ziekenhuis Maastricht
      • Nijmegen, Netherlands
        • Universitair Medisch Centrum Sint Radboud
      • Rotterdam, Netherlands
        • Maasstad Ziekenhuis
      • Rotterdam, Netherlands
        • Sint Franciscus Gasthuis
      • The Hague, Netherlands
        • HagaZiekenhuis
      • Zwolle, Netherlands
        • Isala Klinieken

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 NSCLC, locally advanced and metastatic disease stage IIIB and IV. Evidence of disease progression after one or two cytotoxic treatment regimens which should have included a platinum agent.
  2. Complete recovery from prior chemotherapy side effects to < Grade 2.
  3. At least one unidimensional measurable lesion meeting RECIST criteria.
  4. ECOG PS 0-2.
  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, AP, ALT, AST < 1.5 x ULN AP, ALT, and AST <5 x ULN is acceptable if the liver has tumor involvement
    • Renal: calculated creatinin clearance > 40 ml/min based on the Cockcroft-Gault formula.
  7. Estimated life expectancy >12 weeks.
  8. 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.
  9. Signed informed consent.
  10. Patient compliance and geographical proximity that allow adequate follow up.

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 and has been off corticosteroids for at least two weeks before enrollment.
  4. Previous treatment with an EGFR-TKI, or in non-squamous histology earlier treatment with pemetrexed and in squamous earlier treatment with docetaxel.
  5. Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period (5 day period for long-acting agents such as piroxicam).
  6. Inability or unwillingness to take folic acid, vitamin B-12 supplementation or dexamethasone.
  7. Concomitant treatment with any other experimental drug under investigation.

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
Experimental: 1
Erlotinib plus docetaxel (squamous cell NSCLC) or pemetrexed (non-squamous cell NSCLC)
Drug: erlotinib plus docetaxel or pemetrexed

non-squamous carcinoma: pemetrexed 500 mg/m2 on Day 1 plus erlotinib 150 mg/day days 2-16, every 21 days. Pemetrexed will be given for a maximum of 4 cycles. Thereafter erlotinib will be continued continuously until disease progression.

squamous carcinoma: Docetaxel 75mg/m2 on Day 1 plus erlotinib 150mg/day days 2-16, every 21 days. Docetaxel will be given for a maximum of 4 cycles. Thereafter erlotinib will be continued continuously until disease progression.

Other Names:
  • Taxotere
  • Tarceva
  • Alimta
Active Comparator: 2
Erlotinib
Drug: erlotinib
erlotinib 150 mg/day continuously until disease progression
Other Names:
  • Tarceva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: From randomisation to date of first progression or date of death, assessed up to 36 months
to compare the PFS in the group receiving erlotinib alone versus the patients receiving erlotinib + single agent Progression free survival
From randomisation to date of first progression or date of death, assessed up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Adverse Events
Time Frame: From randomisation to 30 days after EoT all AEs are collected
to compare relevant toxicity (CTC AE vs 3.0) in the group receiving erlotinib alone versus the patients receiving erlotinib + single agent
From randomisation to 30 days after EoT all AEs are collected

Collaborators and Investigators

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

Sponsor

Dutch Society of Physicians for Pulmonology and Tuberculosis

Investigators

  • Study Director: Joachim G. Aerts, MD PhD, Amphia Ziekenhuis, Breda, The Netherlands
  • Study Director: Henk E. Coderington, MD, HagaZiekenhuis, the Hague, The Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

March 1, 2009

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

February 2, 2009

First Submitted That Met QC Criteria

February 2, 2009

First Posted (Estimate)

February 3, 2009

Study Record Updates

Last Update Posted (Actual)

September 29, 2020

Last Update Submitted That Met QC Criteria

September 25, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NVALT10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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