Docetaxel Versus Intercalated Erlotinib-docetaxel in Patients With Relapsed EGFR Wild Type, ALK Negative Non Squamous Cell Carcinoma

NCT02775006 | Terminated Phase 3

• 1 other identifier: NVALT 18
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 19

Brief Summary

The objective of this study is to investigate the effect of docetaxel monotherapy and the combination of docetaxel intercalated erlotinib in patients with relapsed EGFR wild type, ALK negative non squamous cell carcinoma.

Conditions

Carcinoma, Non-small Cell Lung

Outcome Measures

Primary Outcomes (1)

• progression free survival

  from the date of randomization to the first date of progression of disease or of death from any cause up to 24 months after last treatment administration

Secondary Outcomes (4)

• quantitative and qualitative adverse events

  from the date of randomization until resolution or stabilization of the event and up to 30 days after the last study medication/treatment

• response rates

  Every six weeks from date of randomization until the date of first documented progression or date of death from any cause up to 24 months after last treatment administration

• duration of response

  from the date of the first objective status assessment of a complete or partial response to the first date of progression of disease or death from any cause up to 24 months after last treatment administration

• overall survival

  from the date of randomization to the date of death from any cause up to 24 months after last treatment administration

Other Outcomes (1)

• Erlotinib dose level variance in blood

  Every six weeks from randomisation up until last treatment administration (up until 48 weeks)

Study Arms (2)

Docetaxel

ACTIVE COMPARATOR

Docetaxel 75mg/m2 every 21 days until disease progression or toxicity related

Drug: Docetaxel

Docetaxel plus erlotinib

ACTIVE COMPARATOR

Docetaxel 75mg/m2 on Day 1 plus erlotinib 150mg/day days 2-16, every 21 days, until disease progression, or toxicity related.

Drug: Docetaxel; Drug: Erlotinib

Interventions

Docetaxel DRUG

75mg/m2

Also known as: Taxotere

Docetaxel; Docetaxel plus erlotinib

Erlotinib DRUG

150mg/day

Also known as: Tarceva

Docetaxel plus erlotinib

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed EGFR wild type, ALK negative, non-squamous cell carcinoma, locally advanced and metastatic disease stage IIIB and IV. Evidence of disease progression after one cytotoxic treatment platinum containing regimen. Immunotherapy pretreatment is allowed
• Complete recovery from prior chemotherapy side effects to \< Grade 2.
• At least one unidimensionally measurable lesion meeting RECIST criteria.
• ECOG PS 0-1.
• Age ≥ 18 years.
• Adequate organ function, including:
• Adequate bone marrow reserve: ANC \> 1.5 x 109/L, platelets ≥ 100 x 109/L.
• Hepatic: bilirubin ≤1.5 x ULN (upper limit normal), AP, ALT, AST ≤ 1.5 x ULN. AP, ALT, and AST ≤5 x ULN is acceptable if the liver has tumor involvement.
• Renal: calculated creatinine clearance ≥ 40 ml/min based on the Cockcroft-Gault formula.
• Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate. Female patients with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
• Signed informed consent.
• Patient compliance and geographical proximity that allow adequate follow up.

You may not qualify if:

• Pregnant or lactating women.
• Patients with medical risks because of non-malignant disease as well as those with active uncontrolled infection.
• Documented brain metastases unless the patient has completed local therapy for central nervous system metastases at least 4 weeks before enrollment and has been off corticosteroids for at least two weeks before enrollment. Prophylactic irradiation at least 4 weeks prior to enrollment is accepted.
• Maintenance treatment with erlotinib or other TKI (Tyrosine Kinase Inhibitor), or docetaxel. Maintenance treatment with pemetrexed is allowed. Previous treatment with an EGFR-TKI or docetaxel within 6 months prior to enrollment.
• Inability or unwillingness to take dexamethasone.
• Concomitant treatment with any other experimental drug under investigation.
• Patients experiencing disease progression within 2 months after the start of platinum based chemotherapy

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead
• Dutch Society of Physicians for Pulmonology and Tuberculosis: collaborator

Study Sites (19)

VUmc Medical Center

Amsterdam, North Holland, 1081HV, Netherlands

Location

Jeroen Bosch Hospital

's-Hertogenbosch, Netherlands

Location

Gelre Ziekenhuis

Apeldoorn, Netherlands

Location

Amphia Hospital

Breda, Netherlands

Location

Albert Schweitzer ziekenhuis

Dordrecht, Netherlands

Location

Ziekenhuis Gelderse Vallei

Ede, Netherlands

Location

Maxima Medisch Centrum

Eindhoven, 5631 BM, Netherlands

Location

Martini Ziekenhuis

Groningen, Netherlands

Location

Spaarne Gasthuis

Hoofddorp, 2130 AT, Netherlands

Location

MCL

Leeuwarden, 8934 AD, Netherlands

Location

Maastricht University Medical Center

Maastricht, Netherlands

Location

Laurentius Hospital

Roermond, Netherlands

Location

St. Fransicus Gasthuis

Rotterdam, 3045 PM, Netherlands

Location

Ikazia

Rotterdam, 3083 AN, Netherlands

Location

Erasmus MC

Rotterdam, Netherlands

Location

Haga

The Hague, 2545 CH, Netherlands

Location

Medical Center Haaglanden

The Hague, Netherlands

Location

St. Antonius ziekenhuis

Utrecht, Netherlands

Location

VieCuri Medisch Centrum voor Noord-Limburg

Venlo, Netherlands

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel; Erlotinib Hydrochloride

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)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Joachim G Aerts, MD PhD

  Dutch Society of Physicians for Pulmonology and Tuberculosis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: May 17, 2016
• Study Start: October 14, 2016
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: April 30, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (19)