Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Carcinoma

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Docetaxel

Erlotinib Hydrochloride

Tubulin Modulators

Antimitotic Agents

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Erlotinib in standard dose. Until progression (clinical or radiological) or unacceptable toxicity.

Docetaxel in standard dose. Until progression (clinical or radiological) or unacceptable toxicity.

Erlotinib 150 mg/day p.o. continuously with 21 days cycle.

Erlotinib

Docetaxel 75 mg/m2 as an IV infusion every 21 days.

Solange Peters, MD-PhD

Egbert Smit, MD-PhD

Rolf Stahel, MD

Using a laboratory test (VeriStrat), patients with relapsed squamous cell lung cancer are assigned to two strata, VSG (VeriStrat Good) and VSP (VeriStrat Poor). They are then randomized between an EGFR-TK inhibitor (erlotinib) and chemotherapy (Docetaxel).

It is hypothesized that the VeriStrat test results are able to predict the benefit of treatment with erlotinib vs docetaxel. This would suggest a significant improvement in progression-free survival for VSG patients when treated with Erlotinib, and no significant improvement in VSP patients who receive the same treatment.

Goals of the study:

1. Explore the predictive ability of the VeriStrat signature, by testing for interaction between treatment arms (Arm A: erlotinib vs Arm B: docetaxel) and VeriStrat status (VSG vs VSP) using as outcome progression free survival.
2. Explore whether treatment with erlotinib provides progression free survival benefit as compared to docetaxel in the VSG group.
3. Compare progression free survival in the two treatment arms (Arm A: erlotinib vs Arm B: docetaxel) in the VSP group.
4. Explore the prognostic ability of the VeriStrat signature by testing for an overall difference in progression free survival between the two VeriStrat groups (in case of no significant interaction).
5. Explore the predictive ability of the VeriStrat signature using the secondary measures of clinical efficacy including overall survival, objective response rate, and disease control rate.
6. Compare overall survival, objective response rate and disease control rate between treatment groups separately in the VSG and VSP groups.
7. Explore the prognostic ability of the VeriStrat signature by testing for an overall difference in overall survival, objective response rate and disease control rate between the two VeriStrat groups (in case of no significant interaction).
8. Assess the safety and the tolerability of the two treatments separately in each VeriStrat group and overall.

Recruitment period: 18 months Sample Size: 500

Testing of Drugs Erlotinib and Docetaxel in Lung Cancer Patients Classified Regarding Their Outlook Using VeriStrat®.

A Randomized Phase III Trial of Erlotinib Versus Docetaxel in Patients With Advanced Squamous Cell Non-small Cell Lung Cancer Who Failed First Line Platinum Based Doublet Chemotherapy Stratified by VeriStrat Good vs VeriStrat Poor

Time from the date of randomization until documented progression or death without documented progression.

Assessment of Progressive Disease (PD) based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) Target lesions:At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.(Note: the appearance of one or more new lesions is also considered progression).

Non-target lesions:Unequivocal progression of existing non-target lesions. (Note:the appearance of one or more new lesions is also considered progression). To achieve 'unequivocal progression', there must be an overall level of substantial worsening in non-target disease such that,even in presence of SD or PR in target disease, the overall tumour burden has increased sufficiently

Defined as time from the date of randomization until death from any cause.

Objective response is defined as best overall response (CR or PR) across all assessment time-points according to RECIST Criteria 1.1 during the period from randomization to termination of trial treatment.

Disease control is defined as achieving objective response or stable disease for at least 6 weeks.

Adverse events classified according to NCI CTCAE version 4

Biodesix, Inc.

ETOP IBCSG Partners Foundation

One patient from the Docetaxel arm never started treatment.

Erlotinib in standard dose. Until progression (clinical or radiological) or unacceptable toxicity.

Erlotinib: Erlotinib 150 mg/day p.o. continuously with 21 days cycle.

A: Erlotinib

Docetaxel in standard dose. Until progression (clinical or radiological) or unacceptable toxicity.

Docetaxel: Docetaxel 75 mg/m2 as an IV infusion every 21 days.

B: Docetaxel

Total

Age, Continuous

Sex: Female, Male

Smoking history

ECOG Performance status scaling:

PS 0:Fully active, able to carry on all pre-disease performance without restriction PS 1:Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work PS 2:Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours PS 3:Capable of only limited self-care, confined to bed or chair more than 50% of waking hours PS 4:Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Testing of Drugs Erlotinib and Docetaxel in Lung Cancer Patients Classified Regarding Their Outlook Using VeriStrat®.	NCT01652469	Carcinoma, Non-...	Erlotinib Docetaxel	18 Years -	ETOP IBCSG Partners Foundation
Testing of Drugs Erlotinib and Docetaxel in Lung Cancer Patients Classified Regarding Their Outlook Using VeriStrat®.	NCT01652469	Carcinoma, Non-...	Erlotinib Docetaxel	18 Years -	ETOP IBCSG Partners Foundation
Testing of Drugs Erlotinib and Docetaxel in Lung Cancer Patients Classified Regarding Their Outlook Using VeriStrat®.	NCT01652469	Carcinoma, Non-...	Erlotinib Docetaxel	18 Years -	ETOP IBCSG Partners Foundation

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