Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00835471
Recruitment Status : Completed
First Posted : February 3, 2009
Last Update Posted : September 29, 2020
Sponsor:
Information provided by (Responsible Party):
Dutch Society of Physicians for Pulmonology and Tuberculosis

Tracking Information
First Submitted Date  ICMJE February 2, 2009
First Posted Date  ICMJE February 3, 2009
Last Update Posted Date September 29, 2020
Study Start Date  ICMJE March 2009
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 2, 2009)
Progression free survival [ Time Frame: During study ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2020)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2009)
  • Safety [ Time Frame: During study ]
  • Response rate [ Time Frame: During study ]
  • Duration of response [ Time Frame: During study ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 2nd Line Erlotinib Treatment With (Out) Chemotherapy of Advanced Non Small Cell Lung Cancer (NSCLC)
Official Title  ICMJE A Randomized Phase II Study of Erlotinib Compared to Single Agent Chemotherapy-erlotinib Combination in Pretreated Patients With Advanced NSCLC (NVALT10 Study)
Brief Summary 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).
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • 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:
    • Tarceva
    • Taxotere
    • Alimta
  • Drug: erlotinib
    erlotinib 150 mg/day continuously until disease progression
    Other Name: Tarceva
Study Arms  ICMJE
  • Experimental: 1
    Erlotinib plus docetaxel (squamous cell NSCLC) or pemetrexed (non-squamous cell NSCLC)
    Intervention: Drug: erlotinib plus docetaxel or pemetrexed
  • Active Comparator: 2
    Erlotinib
    Intervention: Drug: erlotinib
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 25, 2020)
195
Original Estimated Enrollment  ICMJE
 (submitted: February 2, 2009)
230
Actual Study Completion Date  ICMJE June 2019
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00835471
Other Study ID Numbers  ICMJE NVALT10
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dutch Society of Physicians for Pulmonology and Tuberculosis
Study Sponsor  ICMJE Dutch Society of Physicians for Pulmonology and Tuberculosis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Joachim G. Aerts, MD PhD Amphia Ziekenhuis, Breda, The Netherlands
Study Director: Henk E. Coderington, MD HagaZiekenhuis, The Hague, The Netherlands
PRS Account Dutch Society of Physicians for Pulmonology and Tuberculosis
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP