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Phase II ERCC1 and RRM1-Based Adjuvant Therapy Trial in Patients With Stage I Non-Small Cell Lung Cancer (NSCLC)

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

Thank you

Trial Information

Phase II ERCC1 and RRM1-Based Adjuvant Therapy Trial in Patients With Stage I Non-Small Cell Lung Cancer (NSCLC)



- To assess the feasibility of assigning adjuvant treatment based on tumoral RRM1 and
ERCC1 gene expression in patients with complete surgical resection of stage IA (≥ 2 cm)
or IB non-small cell lung cancer.


- To estimate the collective 2-year disease-free survival of these patients.

- To assess the frequency and severity of toxicities resulting from the administration of
cisplatin and gemcitabine hydrochloride.

- To explore, preliminarily, the relationship between RNA and protein expression of RRM1
and ERCC1, and the relationship between RRM1 and ERCC1 expression in the formalin-fixed
and paraffin-embedded tumor specimens, and to generate results on in situ protein
expression and other assays for genes involved in drug efficacy.

- To assess the analytical performance of the biomarker assay.

OUTLINE: This is a multicenter study.

Patients are assigned to 1 of 2 treatment arms based on RRM1 and ERCC1 gene expression.

- Arm I (RRM1 ≥ 40 and ERCC1 ≥ 65): Patients undergo active monitoring after surgery with
disease assessments at 8, 16, and 24 weeks.

- Arm II (RRM1 < 40 and/or ERCC1 < 65): Beginning within 84 days after surgery, patients
receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV
over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the
absence of disease progression or unacceptable toxicity.

Tumor samples acquired at the time of surgery are analyzed by immunofluorescence-based
automated quantitative analysis for in situ expression of RRM1 and ERCC1. If available,
additional samples are assessed using RT-PCR and real-time quantitative PCR for RRM1 and
ERCC1 expression levels; polymorphism analysis for RRM1 and ERCC1 expression at the protein
level; and tissue microarray analysis of genes associated with DNA synthesis, damage repair,
and drug efficacy.

After completion of study therapy, patients are followed every 6 months for up to 2 years.

Inclusion Criteria


- Histologically confirmed non-small cell lung cancer

- Stage IA (longest tumor diameter 2-3 cm) or stage IB disease

- Must have undergone preoperative CT scan of the chest (including the entire liver and
adrenals) with IV contrast AND a whole body PET scan or a combined PET/CT scan with
no evidence of N1, N2, N3, or M1 disease within 42 days prior to surgery

- A whole body PET scan or a combined PET/CT must be performed within 84 days

- Any finding on PET scan that clinically suggests N1, N2, N3, or M1 disease must
have been cleared by further evaluation, including, but not limited to, any of
the following:

- Ultrasonography, X-ray radiology, magnetic resonance imaging, or nuclear
medicine imaging

- Completely resected (R0) disease by lobectomy, bilobectomy, or pneumonectomy
performed by open thoracotomy or video-assisted thoracoscopic surgery within the past
35 days

- Completely excised primary lesion with negative gross and microscopic margins

- At least two mediastinal lymph node stations sampled

- Must have tumor tissue available from the surgical resection specimen AND agree to
have treatment assignment determined by a gene expression analysis performed on that


- Zubrod performance status 0-1

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 10 mg/dL

- Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST and ALT ≤ 1.5 times ULN

- Serum creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No other prior malignancy except for the following:

- Adequately treated basal cell or squamous cell skin cancer

- In situ cervical cancer

- Adequately treated stage I-II cancer from which the patient is currently in
complete remission

- Any other cancer from which the patient has been disease-free for 5 years

- Willing to provide prior smoking history


- See Disease Characteristics

- No prior systemic chemotherapy or biologic therapy for lung cancer

- No prior thoracic radiation therapy (RT) (including RT to the chest wall)

- No other concurrent investigational agents, chemotherapeutic agents, RT, or hormonal

- Steroids administered for antiemesis, adrenal failure, or septic shock OR
hormones administered for non-disease-related conditions (e.g., insulin for
diabetes) allowed

Type of Study:


Study Design:

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

Outcome Measure:

Feasibility of pharmacogenomics-based treatment assignment in the cooperative group setting

Outcome Time Frame:

From time of registration to maximum of 2 years

Safety Issue:


Principal Investigator

Ralph G. Zinner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:




Start Date:

November 2008

Completion Date:

Related Keywords:

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



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