Know Cancer

or
forgot password

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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

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


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


Inclusion Criteria:



- Histologically or cytologically confirmed locally advanced stage IIIB, not amenable
to radical radiotherapy, or metastatic stage IV non-small cell lung cancer (NSCLC) of
predominant squamous subtype, according to the 7th edition of the TNM classification,
including M1a (separate tumor nodule in a contralateral lobe, tumor with pleural
nodules or malignant pleural or pericardial effusion) and/or M1b (distant
metastasis).

- Progressive disease upon or after previous chemotherapy including at least one line
of platinum-based chemotherapy.

- Measurable or evaluable disease according to RECIST v1.1 (Appendix 2).

- ECOG PS 0-2.

- 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; AP, ALT < 3.0 x ULN; AP, ALT <5 x ULN is acceptable in
case of liver metastasis.

- Renal: calculated creatinine clearance > 40 ml/min based on the Cockroft and Gault
formula.

- Signed and dated informed consent form.

- Male and female patients with reproductive potential must use an approved
contraceptive method, during the trial and 12 months thereafter. Female patients with
reproductive potential must have a negative pregnancy test within 7 days prior to
study registration.

- Estimated life expectancy >12 weeks.

- Patient compliance and geographical proximity that allow adequate follow-up.

Exclusion Criteria:

- Evidence of other medical condition which would impair the ability of the patient to
participate in the trial or might preclude therapy with trial drugs (e.g. unstable or
uncompensated respiratory, cardiac, hepatic or renal disease, active infection,
uncontrolled diabetes mellitus).

- Previous treatment with any EGFR-TKI or docetaxel.

- Documented brain metastases unless the patient has completed local therapy for
central nervous system metastases and has been off corticosteroids for at least 14
days prior to study registration.

- Documented presence of activating EGFR mutations, if the patient was tested for EGFR
mutations.

- Previous malignancy within the past 5 years with the exception of adequately treated
cervical carcinoma in situ, breast cancer in situ or localized non-melanoma skin
cancer.

- Psychiatric disorder precluding understanding of information on trial related topics,
giving informed consent, or interfering with compliance for oral drug intake.

- Concurrent treatment with experimental drugs or other anti-cancer therapy treatment
in a clinical trial within 21 days prior to study registration.

- Known hypersensitivity to trial drugs or hypersensitivity to any other component of
the trial drugs or any concomitant drugs contraindicated.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Description:

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

Outcome Time Frame:

The combined run in period, treatment and follow-up for PFS is expected to extend the study duration to a total of 24 months.

Safety Issue:

No

Principal Investigator

Solange Peters, MD-PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Centre Pluridisciplinaire d'Oncologie, Centre Hospitalier Universitaire Vaudois, 1011 Lausanne, Switzerland

Authority:

Switzerland: Swissmedic

Study ID:

ETOP3-12

NCT ID:

NCT01652469

Start Date:

August 2012

Completion Date:

August 2016

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • squamous cell
  • NSCLC
  • TKI
  • Erlotinib
  • Docetaxel
  • VeriStrat
  • protein signature
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location