NCT02064491
Completed
Phase 2
Erlotinib Treatment Beyond Progression in EGFR Mutant or Patients Who Have Responded EGFR TKI in Stage IIIB/IV NSCLC
Finnish Lung Cancer Group6 sites in 1 country18 target enrollmentFebruary 2014
Overview
- Phase
- Phase 2
- Intervention
- Erlotinib
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- Finnish Lung Cancer Group
- Enrollment
- 18
- Locations
- 6
- Primary Endpoint
- Progression-free survival of the whole study population and in the strata 1-2
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
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
Arms & Interventions
Erlotinib and Chemotherapy
Intercalated erlotinib in combination with chemotherapy for four to six cycles followed by continuous erlotinib maintenance
Intervention: Erlotinib
Erlotinib and Chemotherapy
Intercalated erlotinib in combination with chemotherapy for four to six cycles followed by continuous erlotinib maintenance
Intervention: Chemotherapy
Chemotherapy
Chemotherapy for four to six cycles
Intervention: Chemotherapy
Outcomes
Primary Outcomes
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 Outcomes
- Overall Response Rate(An expected average of 36 weeks after last subject enrolled into our study)
- Rate of non-progression at 9 and 18 weeks(18 weeks after date of randomization of a last patient)
- Overall Survival(An expected average of 52 weeks after last subject enrolled into our study)
- Safety and toxicity(An expected average of 52 weeks after last subject enrolled into our study)
Study Sites (6)
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