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Randomized Proteomic Stratified Phase III Study of Second-Line Erlotinib Versus Chemotherapy in Patients With Inoperable Non Small Cell Lung Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

Randomized Proteomic Stratified Phase III Study of Second-Line Erlotinib Versus Chemotherapy in Patients With Inoperable Non Small Cell Lung Cancer


OBJECTIVES:

- To evaluate the predictive value of proteomic profiling on the effect of second-line
therapy with erlotinib hydrochloride vs standard chemotherapy (pemetrexed disodium or
docetaxel) in patients with advanced non-small cell lung cancer.

- To assess the role of other known tissue-based predictive markers (e.g., EGFR-gene copy
number, EGFR-protein expression, pAkt, pMAPK, EGFR mutations, EMT markers, and k-Ras
mutation).

OUTLINE: This is a multicenter study. Patients are stratified according to smoking status,
performance status, proteomic profile, and participating center. Patients are randomized to
1 of 2 treatment arms.

- Arm I: Patients receive standard chemotherapy with pemetrexed disodium, docetaxel, or
another standard drug.

- Arm II: Patients receive standard non-chemotherapy treatment with erlotinib
hydrochloride.

Serum is collected after failure of first-line therapy for proteomic analysis by
matrix-associated laser desorption/ionization-time of flight. Tissue and blood samples are
collected periodically for analysis including EGFR based on IHC and FISH, EGFR and k-Ras
mutations, pAkt, pMAPK by IHC, and EMT markers based on IHC and breath condensate protein
profile.

After completion of study treatment, patients are followed every 2 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed diagnosis of non-small cell lung cancer
(NSCLC)

- Advanced NSCLC (stage IIIB or IV)

- Measurable disease

- Underwent previous treatment with 1 non-tyrosine kinase inhibitor as first-line
therapy for advanced NSCLC

- No clinical evidence of uncontrolled brain metastases

PATIENT CHARACTERISTICS:

- Caucasian

- ECOG performance status 0-2

- Absolute granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Bilirubin ≤ 1.5 times upper limit of normal (ULN) (≤ 2.5 times ULN in patients with
known liver metastases)

- ALT or AST ≤ 3 times ULN (≤ 5 times ULN in patients with known liver metastases)

- Creatinine clearance ≥ 50 mL/min

- Not pregnant or nursing

- Able to comply with planned study procedures

- No multiple severe diseases that can compromise safety (cardiac and renal failure,
peripheral neuropathy)

- No other malignancy (except for basal cell skin carcinoma) or pre-neoplastic
condition requiring chemotherapeutic treatment

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- At least 3 weeks since prior surgery or radiotherapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Safety Issue:

No

Principal Investigator

Vanesa Gregor, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Istituto Scientifico H. San Raffaele

Authority:

Unspecified

Study ID:

CDR0000652115

NCT ID:

NCT00989690

Start Date:

February 2008

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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