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

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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

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).

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: erlotinib plus docetaxel or pemetrexed Drug: erlotinib Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Erlotinib Compared to Single Agent Chemotherapy-erlotinib Combination in Pretreated Patients With Advanced NSCLC (NVALT10 Study)
Study Start Date : March 2009
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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:
  • Tarceva
  • Taxotere
  • Alimta

Active Comparator: 2
Erlotinib
Drug: erlotinib
erlotinib 150 mg/day continuously until disease progression
Other Name: Tarceva




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00835471


Locations
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Netherlands
VU medisch centrum
Amsterdam, Netherlands
Rode Kruis Ziekenhuis
Beverwijk, Netherlands
Amphia Ziekenhuis
Breda, Netherlands
Reinier de Graaf Gasthuis
Delft, Netherlands
Jeroen Bosch Ziekenhuis
Den Bosch, Netherlands
Catharina-Ziekenhuis
Eindhoven, Netherlands
Martini Ziekenhuis
Groningen, Netherlands
Kennemer Gasthuis
Haarlem, Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands
Universitair Medisch Centrum Sint Radboud
Nijmegen, Netherlands
Maasstad Ziekenhuis
Rotterdam, Netherlands
Sint Franciscus Gasthuis
Rotterdam, Netherlands
HagaZiekenhuis
The Hague, Netherlands
Isala Klinieken
Zwolle, Netherlands
Sponsors and Collaborators
Dutch Society of Physicians for Pulmonology and Tuberculosis
Investigators
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Study Director: Joachim G. Aerts, MD PhD Amphia Ziekenhuis, Breda, The Netherlands
Study Director: Henk E. Coderington, MD HagaZiekenhuis, The Hague, The Netherlands
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dutch Society of Physicians for Pulmonology and Tuberculosis
ClinicalTrials.gov Identifier: NCT00835471    
Other Study ID Numbers: NVALT10
First Posted: February 3, 2009    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020
Keywords provided by Dutch Society of Physicians for Pulmonology and Tuberculosis:
Lung cancer
non-small-cell
erlotinib
chemotherapy
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Erlotinib Hydrochloride
Pemetrexed
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors