Erlotinib Treatment Beyond Progression in EGFR Mutant NSCLC

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

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.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Erlotinib; Drug: Chemotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2

Contacts and Locations

Study Locations

• Finland
  • Espoo, Finland
    • Helsinki University Hospital
  • Helsinki, Finland
    • Helsinki University Hospital
  • Oulu, Finland
    • Oulu University Hospital
  • Pori, Finland
    • Pori Central Hospital
  • Tampere, Finland
    • Tampere University Hospital
  • Turku, Finland
    • Turku University Hopital
  • Vaasa, Finland
    • Vaasa Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Tarceva; Drug: Chemotherapy; Other Names: Cisplatin, Carboplatin, Docetaxel, Paclitaxel, Pemetrexed
Active Comparator: Chemotherapy; Chemotherapy for four to six cycles	Drug: Chemotherapy; Other Names: Cisplatin, Carboplatin, Docetaxel, Paclitaxel, Pemetrexed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Finnish Lung Cancer Group
• Collaborators: Roche Pharma AG

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): May 31, 2017

Study Registration Dates

• First Submitted: February 13, 2014
• First Submitted That Met QC Criteria: February 14, 2014
• First Posted (Estimate): February 17, 2014

Study Record Updates

• Last Update Posted (Actual): June 22, 2017
• Last Update Submitted That Met QC Criteria: June 21, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Non-small cell lung cancer; Erlotinib; Treatment Beyond Progression; EGFR mutant
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Disease Attributes; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Disease Progression; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Protein Kinase Inhibitors; Folic Acid Antagonists; Docetaxel; Carboplatin; Paclitaxel; Erlotinib Hydrochloride; Cisplatin; Pemetrexed
• Other Study ID Numbers: ETAP; 2013-002049-13 (EudraCT Number)