Erlotinib Treatment Beyond Progression in EGFR Mutant NSCLC

Non-small Cell Lung Cancer Clinical Trial

Official title:

Erlotinib Treatment Beyond Progression in EGFR Mutant or Patients Who Have Responded EGFR TKI in Stage IIIB/IV NSCLC

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02064491
• Other study ID #: ETAP
• Secondary ID: 2013-002049-13
• Status: Completed
• Phase: Phase 2
• First received: February 13, 2014
• Last updated: June 21, 2017
• Start date: February 2014
• Est. completion date: May 31, 2017

Study information

• Verified date: June 2017
• Source: Finnish Lung Cancer Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 31, 2017
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Disease Progression
• Non-small Cell Lung Cancer

Intervention

Drug:
• Erlotinib

• Chemotherapy

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
Finnish Lung Cancer Group	Roche Pharma AG

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival of the whole study population and in the strata 1-2		An expected average of 36 weeks after last subject enrolled into our study
Secondary	Overall Survival		An expected average of 52 weeks after last subject enrolled into our study
Secondary	Overall Response Rate		An expected average of 36 weeks after last subject enrolled into our study
Secondary	Rate of non-progression at 9 and 18 weeks		18 weeks after date of randomization of a last patient
Secondary	Safety and toxicity	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	An expected average of 52 weeks after last subject enrolled into our study