Erlotinib Treatment Beyond Progression in EGFR Mutant NSCLC

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Erlotinib
* Drug: Chemotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erlotinib and Chemotherapy<br>Intercalated erlotinib in combination with chemotherapy for four to six cycles followed by continuous erlotinib maintenance | Drug: Erlotinib<br> <br> * Other names: Tarceva;Drug: Chemotherapy<br> <br> * Other names: Cisplatin, Carboplatin, Docetaxel, Paclitaxel, Pemetrexed;|
| Active Comparator: Chemotherapy<br>Chemotherapy for four to six cycles | Drug: Chemotherapy<br> <br> * Other names: Cisplatin, Carboplatin, Docetaxel, Paclitaxel, Pemetrexed;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | An expected average of 52 weeks after last subject enrolled into our study | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-small cell lung cancer, EGFR mutant, Erlotinib, Treatment Beyond Progression