Erlotinib Treatment Beyond Progression in EGFR Mutant NSCLC

NCT02064491 | Completed Phase 2 DMC

• 2 other identifiers: ETAP2013-002049-13
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 7

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.

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small cell lung cancer; EGFR mutant; Erlotinib; Treatment Beyond Progression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  An expected average of 52 weeks after last subject enrolled into our study

Study Arms (2)

Erlotinib and Chemotherapy

EXPERIMENTAL

Intercalated erlotinib in combination with chemotherapy for four to six cycles followed by continuous erlotinib maintenance

Drug: Erlotinib; Drug: Chemotherapy

Chemotherapy

ACTIVE COMPARATOR

Chemotherapy for four to six cycles

Drug: Chemotherapy

Interventions

Erlotinib DRUG

Also known as: Tarceva

Erlotinib and Chemotherapy

Chemotherapy DRUG

Also known as: Cisplatin, Carboplatin, Docetaxel, Paclitaxel, Pemetrexed

Chemotherapy; Erlotinib and Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Finnish Lung Cancer Group: lead
• Roche Pharma AG: collaborator

Study Sites (7)

Helsinki University Hospital

Espoo, Finland

Location

Helsinki University Hospital

Helsinki, Finland

Location

Oulu University Hospital

Oulu, Finland

Location

Pori Central Hospital

Pori, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Turku University Hopital

Turku, Finland

Location

Vaasa Central Hospital

Vaasa, Finland

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride; Drug Therapy; Cisplatin; Carboplatin; Docetaxel; Paclitaxel; Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2014
• First Posted: February 17, 2014
• Study Start: February 1, 2014
• Primary Completion: December 31, 2016
• Study Completion: May 31, 2017
• Last Updated: June 22, 2017

Record last verified: 2017-06

Locations

FI (7)