NCT00835471

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2009

Longer than P75 for phase_2

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2009

Completed
26 days until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

September 29, 2020

Status Verified

September 1, 2020

Enrollment Period

5.3 years

First QC Date

February 2, 2009

Last Update Submit

September 25, 2020

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Lung cancernon-small-cellerlotinibchemotherapy

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival (PFS)

    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 Outcomes (1)

  • Number of Adverse Events

    From randomisation to 30 days after EoT all AEs are collected

Study Arms (2)

1

EXPERIMENTAL

Erlotinib plus docetaxel (squamous cell NSCLC) or pemetrexed (non-squamous cell NSCLC)

Drug: erlotinib plus docetaxel or pemetrexed

2

ACTIVE COMPARATOR

Erlotinib

Drug: erlotinib

Interventions

erlotinib plus docetaxel or pemetrexedDRUG

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.

Also known as: Tarceva, Taxotere, Alimta
1
erlotinibDRUG

erlotinib 150 mg/day continuously until disease progression

Also known as: Tarceva
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Complete recovery from prior chemotherapy side effects to \< Grade 2.
  • At least one unidimensional measurable lesion meeting RECIST criteria.
  • ECOG PS 0-2.
  • Age \> 18 years.
  • 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.
  • Estimated life expectancy \>12 weeks.
  • 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.
  • Signed informed consent.
  • Patient compliance and geographical proximity that allow adequate follow up.

You may not qualify if:

  • Pregnant or lactating women.
  • Patients with medical risks because of non-malignant disease as well as those with active uncontrolled infection.
  • 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.
  • Previous treatment with an EGFR-TKI, or in non-squamous histology earlier treatment with pemetrexed and in squamous earlier treatment with docetaxel.
  • 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).
  • Inability or unwillingness to take folic acid, vitamin B-12 supplementation or dexamethasone.
  • Concomitant treatment with any other experimental drug under investigation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Netherlands

Location

VU medisch centrum

Amsterdam, Netherlands

Location

Rode Kruis Ziekenhuis

Beverwijk, Netherlands

Location

Amphia Ziekenhuis

Breda, Netherlands

Location

Reinier de Graaf Gasthuis

Delft, Netherlands

Location

Catharina-Ziekenhuis

Eindhoven, Netherlands

Location

Martini Ziekenhuis

Groningen, Netherlands

Location

Kennemer Gasthuis

Haarlem, Netherlands

Location

Academisch Ziekenhuis Maastricht

Maastricht, Netherlands

Location

Universitair Medisch Centrum Sint Radboud

Nijmegen, Netherlands

Location

Maasstad Ziekenhuis

Rotterdam, Netherlands

Location

Sint Franciscus Gasthuis

Rotterdam, Netherlands

Location

HagaZiekenhuis

The Hague, Netherlands

Location

Isala Klinieken

Zwolle, Netherlands

Location

Related Publications (4)

  • De Ruysscher D, Dingemans AC, Praag J, Belderbos J, Tissing-Tan C, Herder J, Haitjema T, Ubbels F, Lagerwaard F, El Sharouni SY, Stigt JA, Smit E, van Tinteren H, van der Noort V, Groen HJM. Prophylactic Cranial Irradiation Versus Observation in Radically Treated Stage III Non-Small-Cell Lung Cancer: A Randomized Phase III NVALT-11/DLCRG-02 Study. J Clin Oncol. 2018 Aug 10;36(23):2366-2377. doi: 10.1200/JCO.2017.77.5817. Epub 2018 May 22.

    PMID: 29787357RESULT

  • Witlox WJA, Ramaekers BLT, Groen HJM, Dingemans AM, Praag J, Belderbos J, van der Noort V, van Tinteren H, Joore MA, De Ruysscher DKM. Factors determining the effect of prophylactic cranial irradiation (PCI) in patients with stage-III nonsmall cell lung cancer: exploratory subgroup analyses of the NVALT-11/DLCRG-02 phase-III study. Acta Oncol. 2019 Oct;58(10):1528-1531. doi: 10.1080/0284186X.2019.1629016. Epub 2019 Jul 1. No abstract available.

    PMID: 31256737RESULT

  • Witlox WJA, Ramaekers BLT, Joore MA, Dingemans AC, Praag J, Belderbos J, Tissing-Tan C, Herder G, Haitjema T, Ubbels JF, Lagerwaard J, El Sharouni SY, Stigt JA, Smit EF, van Tinteren H, van der Noort V, Groen HJM, De Ruysscher DKM. Health-related quality of life after prophylactic cranial irradiation for stage III non-small cell lung cancer patients: Results from the NVALT-11/DLCRG-02 phase III study. Radiother Oncol. 2020 Mar;144:65-71. doi: 10.1016/j.radonc.2019.10.016. Epub 2019 Nov 14.

    PMID: 31733490RESULT

  • Aerts JG, Codrington H, Lankheet NA, Burgers S, Biesma B, Dingemans AM, Vincent AD, Dalesio O, Groen HJ, Smit EF; NVALT Study Group. A randomized phase II study comparing erlotinib versus erlotinib with alternating chemotherapy in relapsed non-small-cell lung cancer patients: the NVALT-10 study. Ann Oncol. 2013 Nov;24(11):2860-5. doi: 10.1093/annonc/mdt341. Epub 2013 Aug 28.

    PMID: 23986090DERIVED

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Interventions

Erlotinib HydrochlorideDocetaxelPemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesGuanineHypoxanthinesPurinonesPurinesGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Study Officials

  • Joachim G. Aerts, MD PhD

    Amphia Ziekenhuis, Breda, The Netherlands

    STUDY DIRECTOR

  • Henk E. Coderington, MD

    HagaZiekenhuis, The Hague, The Netherlands

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2009

First Posted

February 3, 2009

Study Start

March 1, 2009

Primary Completion

June 1, 2014

Study Completion

June 1, 2019

Last Updated

September 29, 2020

Record last verified: 2020-09

Locations

NL(14)