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Erlotinib Treatment Beyond Progression in EGFR Mutant NSCLC

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: NCT02064491
Recruitment Status : Completed
First Posted : February 17, 2014
Last Update Posted : June 22, 2017
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Finnish Lung Cancer Group

Brief Summary:
The purpose of this study is to determine whether continuing erlotinib beyond disease progression in combination with chemotherapy is beneficial for NSCLC patients who have EGFR mutant disease or who have responded to EGFR TKI.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Erlotinib Drug: Chemotherapy Phase 2

Detailed Description:
A Phase II randomised, multicenter study to assess the efficacy and safety of continuing erlotinib in addition to chemotherapy versus chemotherapy alone in patients who have EGFR mutant or EGFR TKI responsive NSCLC and have progressed on EGFR TKI.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Erlotinib Treatment Beyond Progression in EGFR Mutant or Patients Who Have Responded EGFR TKI in Stage IIIB/IV NSCLC
Actual Study Start Date : February 2014
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : May 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Erlotinib and Chemotherapy
Intercalated erlotinib in combination with chemotherapy for four to six cycles followed by continuous erlotinib maintenance
Drug: Erlotinib
Other Name: Tarceva

Drug: Chemotherapy
Other Name: Cisplatin, Carboplatin, Docetaxel, Paclitaxel, Pemetrexed

Active Comparator: Chemotherapy
Chemotherapy for four to six cycles
Drug: Chemotherapy
Other Name: Cisplatin, Carboplatin, Docetaxel, Paclitaxel, Pemetrexed




Primary Outcome Measures :
  1. Progression-free survival of the whole study population and in the strata 1-2 [ Time Frame: An expected average of 36 weeks after last subject enrolled into our study ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: An expected average of 52 weeks after last subject enrolled into our study ]
  2. Overall Response Rate [ Time Frame: An expected average of 36 weeks after last subject enrolled into our study ]
  3. Rate of non-progression at 9 and 18 weeks [ Time Frame: 18 weeks after date of randomization of a last patient ]
  4. Safety and toxicity [ Time Frame: An expected average of 52 weeks after last subject enrolled into our study ]
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability



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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:

  • Histologically confirmed stage IIIB/IV NSCLC.
  • Investigator confirmed progression according RECIST 1.1 during EGFR TKI treatment within 28 days of the randomization
  • Activating mutation (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q) in the EGFR gene or have had at least partial response with EGFR TKI lasting ≥ 6 months
  • Performance status: WHO 0-2
  • Measurable disease according to RECIST 1.1
  • Patients must be able to comply with study treatments
  • Women with child-bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study
  • Neutrophils ≥ 1'000/μl, Platelets ≥ 100'000/μl, Alanine amino transferase ≤ 2.5 × Upper limit of normal (ULN) (< 5 × ULN if liver metastases), Alkaline phosphatase ≤ 2.5 × ULN (< 5 × ULN if liver metastases), Serum bilirubin ≤ 1.5 × ULN, Serum Creatinine ≤ 1.5 × ULN.
  • Patient must be able to comply with the protocol

Exclusion Criteria:

  • RECIST 1.1 defined disease progression for more than 28 days while on previous EGFR TKI treatment.
  • Patient has been treated with any investigational agent for any indication within 4 weeks of study treatment.
  • Patient has history of hypersensitivity or intolerance to erlotinib or gefitinib.
  • Patient has history of hypersensitivity or intolerance to chemotherapeutic agents used in the study.
  • Patient with symptomatic central nervous system metastases
  • Patient has known active hepatitis B or C, or HIV infection
  • Pregnant or breastfeeding.
  • Patient with uncontrolled undercurrent illness or circumstances that could limit compliance with the study

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): NCT02064491


Locations
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Finland
Helsinki University Hospital
Espoo, Finland
Helsinki University Hospital
Helsinki, Finland
Oulu University Hospital
Oulu, Finland
Pori Central Hospital
Pori, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hopital
Turku, Finland
Vaasa Central Hospital
Vaasa, Finland
Sponsors and Collaborators
Finnish Lung Cancer Group
Roche Pharma AG
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Responsible Party: Finnish Lung Cancer Group
ClinicalTrials.gov Identifier: NCT02064491    
Other Study ID Numbers: ETAP
2013-002049-13 ( EudraCT Number )
First Posted: February 17, 2014    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017
Keywords provided by Finnish Lung Cancer Group:
Non-small cell lung cancer
EGFR mutant
Erlotinib
Treatment Beyond Progression
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Disease Progression
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Disease Attributes
Pathologic Processes
Paclitaxel
Docetaxel
Cisplatin
Carboplatin
Erlotinib Hydrochloride
Pemetrexed
Antineoplastic Agents, Phytogenic
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