Clinical trial NCT02064491: Erlotinib Treatment Beyond Progression in EGFR Mutant NSCLC
Official title: Erlotinib Treatment Beyond Progression in EGFR Mutant or Patients Who Have Responded EGFR TKI in Stage IIIB/IV NSCLC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Non-small cell lung cancer
EGFR mutant
Erlotinib
Treatment Beyond Progression
Lead sponsor: Finnish Lung Cancer Group
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2014-02-17
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Progression-free survival of the whole study population and in the strata 1-2
timeFrame: An expected average of 36 weeks after last subject enrolled into our study
Secondary outcomes:
measure: Overall Survival
timeFrame: An expected average of 52 weeks after last subject enrolled into our study
measure: Overall Response Rate
timeFrame: An expected average of 36 weeks after last subject enrolled into our study
measure: Rate of non-progression at 9 and 18 weeks
timeFrame: 18 weeks after date of randomization of a last patient
measure: Safety and toxicity
timeFrame: An expected average of 52 weeks after last subject enrolled into our study
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Helsinki University Hospital
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Pori
country: Finland
facility: Pori Central Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hopital
city: Vaasa
country: Finland
facility: Vaasa Central Hospital
Study officials:
References: