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A Randomized Phase III Trial of Adjuvant Chemotherapy in Patients With Early Stage Non-Small Cell Lung Cancer Associated With Banking of Frozen Tumor Specimens and Collection of Gene Expression Profile Data

Phase 3
18 Years
Open (Enrolling)
Lung Cancer

Thank you

Trial Information

A Randomized Phase III Trial of Adjuvant Chemotherapy in Patients With Early Stage Non-Small Cell Lung Cancer Associated With Banking of Frozen Tumor Specimens and Collection of Gene Expression Profile Data



- To determine the potential overall survival benefit of adjuvant chemotherapy in
patients with early stage non-small cell lung cancer (NSCLC) randomized to chemotherapy
compared to those randomized to the present standard of care (observation).

- To collect and process high-quality fresh frozen lung cancer tumor tissue for gene
expression array generation from multiple institutions.


- To evaluate selected genomic-based lung cancer prognostic models using data from the
patients randomized to observation after resection.

- To characterize the rate of chemotherapy toxicity for the different chemotherapy
treatment regimens.

- To assess quality of life (QOL) in early stage patients periodically after resection
for NSCLC.

- To examine the impact of chemotherapy on QOL for patients receiving chemotherapy, as
compared to patients in the observation arm.

OUTLINE: This is a multicenter study. Patients are stratified according to pathologic stage
(I vs II) and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment
arms within 12 weeks after surgery.

All patients undergo complete resection of disease (i.e., lobectomy, sleeve lobectomy,
bi-lobectomy, or pneumonectomy, but not segmentectomy or wedge resection).

- Arm I: Patients receive 1 of 3 chemotherapy regimens. Treatment repeats every 21 days
for up to 4 courses in the absence of disease progression or unacceptable toxicity.

- Regimen 1: Patients receive vinorelbine ditartrate IV over 10 minutes on days 1
and 8 and cisplatin IV over 60 minutes on day 1.

- Regimen 2: Patients receive docetaxel IV over 60 minutes and cisplatin IV over 60
minutes on day 1.

- Regimen 3: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1
and 8 and cisplatin IV over 60 minutes on day 1.

- Regimen 4: Patients receive pemetrexed disodium IV over 10 minutes and cisplatin
IV over 60 minutes on day 1.

- Arm II: Patients receive standard care (observation). Tissue obtained at surgery is
examined by RNA microarray analysis. A Lung Metagene Score (LMS) is determined for each
patient and correlated with survival and response.

After completion of study treatment, patients are followed every 6 months for 5 years and
then once a year for 7 years.

Inclusion Criteria


- Histologically confirmed non-small cell lung cancer

- Any variant allowed (e.g., pure or mixed bronchioloalveolar carcinoma or
adenosquamous cell carcinoma)

- Primary tumor must be T1a, T1b, T2a, or T2b by AJCC 7.0

- No status

- Tumor measuring ≥ 2.0 cm but ≤ 7.0 cm in diameter by CT scan

- The mass must have a source document to verify tumor size in the greatest
dimension, which includes a CT scan report, a clinic note from the enrolling
physician, and/or a printed image with caliper measurements on the lung mass

- Node-negative disease

- Evidence of hilar or mediastinal node involvement by chest CT scan (> 1 cm
diameter) must be assessed with mediastinoscopy, endo-esophageal ultrasound with
biopsy, endo-bronchial ultrasound, bronchoscopy, or mediastinal nodal sampling
before or at time of thoracotomy

- No locally advanced or metastatic disease


- ECOG performance status 0-1

- Granulocytes ≥ 1,500/μL

- Platelet count ≥ 100,000/μL

- Bilirubin ≤ 1.5 mg/dL

- AST < 1.5 times upper limit of normal (ULN)

- Serum creatinine ≤ 1.5 times ULN

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No history of prior or concurrent malignancy, except curatively treated carcinoma in
situ of the cervix, basal cell or squamous cell carcinoma of the skin, surgically
treated in situ carcinoma of the breast, or other cancer for which the patient has
been disease-free for 3 years


- More than 3 years since prior cytotoxic or anticancer treatment

- No concurrent treatment with hormones or other chemotherapeutic agents, except
steroids given for adrenal failure, hormone administered for nondisease-related
conditions (e.g., insulin for diabetes), or intermittent use of dexamethasone as an

- No concurrent thoracic radiotherapy

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Safety Issue:


Principal Investigator

David H. Harpole, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute


United States: Federal Government

Study ID:




Start Date:

March 2009

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage IA non-small cell lung cancer
  • stage IB non-small cell lung cancer
  • stage IIA non-small cell lung cancer
  • adenocarcinoma of the lung
  • adenosquamous cell lung cancer
  • bronchoalveolar cell lung cancer
  • large cell lung cancer
  • squamous cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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