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A Phase II Study of Induction Chemotherapy Followed by Thoracic Radiotherapy and Erlotinib in Poor-Risk Stage III Non-Small Cell Lung Cancer

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

A Phase II Study of Induction Chemotherapy Followed by Thoracic Radiotherapy and Erlotinib in Poor-Risk Stage III Non-Small Cell Lung Cancer



- To determine the activity of induction chemotherapy comprising carboplatin and
paclitaxel albumin-stabilized nanoparticle formulation followed by concurrent thoracic
radiotherapy and erlotinib hydrochloride in patients with poor-risk, unresectable stage
IIIA or IIIB non-small cell lung cancer.


- To determine the response rate and progression-free survival of these patients.

OUTLINE: Patients receive induction chemotherapy comprising paclitaxel albumin-stabilized
nanoparticle formulation IV over 30 minutes on days 1 and 8 and carboplatin IV over 30
minutes on day 1. Treatment repeats every 21 days for 2 courses. Patient with rapid disease
progression outside of the chest after induction therapy are removed from study. Patients
with intrathoracic disease progression within the potential radiation field may continue
protocol therapy at the discretion of the Study Chair. Patients with no disease progression
outside the planned radiation field (either regional or distant) proceed to concurrent
erlotinib hydrochloride and radiotherapy.

Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride once daily.
Patients also undergo concurrent radiotherapy 5 days a week for up to 7 weeks (33 fractions)
in the absence of rapid disease progression outside of the chest or unacceptable toxicity.

After completion of study therapy, patients are followed every 3 months for 1 year, and then
every 6 months for up to 2 years

Inclusion Criteria


- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC),
including any of the following histologies:

- Squamous cell carcinoma

- Adenocarcinoma (including bronchoalveolar cell)

- Large cell anaplastic carcinoma (including giant and clear cell carcinomas)

- Must meet the following criteria:

- T1-3 with N2 and selected N3*

- T4 with N0, N1, N2 and selected N3*

- M0 (no M1 patients) NOTE: *Patients with contralateral mediastinal disease
(i.e., N3) are eligible, provided all gross disease can be encompassed within
the radiation boost field in accordance with the homogeneity criteria. Patients
with ipsilateral scalene or supraclavicular disease are also eligible. Patients
with contralateral hilar or supraclavicular node involvement are not eligible.

- Must have measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20
mm by conventional techniques or ≥ 10 mm by spiral CT scan

- Nonmeasurable lesions include the following:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural or pericardial effusion

- Abdominal masses that are not confirmed and followed by imaging techniques

- Cystic lesions

- Tumor lesions situated in a previously irradiated area

- Patients must be considered unresectable or inoperable AND be deemed candidates for
combined modality therapy by a medical oncologist and a radiation oncologist

- Considered to be poor-risk with NCI CTC performance status (PS) 2 OR PS 0-1 and ≥ 10%
weight loss within the past 3 months

- Patients with tumors adjacent to a vertebral body are eligible, provided all gross
disease can be encompassed within the radiation boost field in accordance with the
homogeneity criteria

- Pleural effusions meeting the following criteria allowed:

- Effusion is transudate, cytologically negative, and non-bloody

- Effusion can be seen on the chest CT scan but not on the chest x-ray AND is too
small to tap

- Effusion appears only after a thoracotomy or other invasive thoracic procedure
was attempted


- See Disease Characteristics

- Granulocytes ≥ 1,500/μL

- Platelet count ≥ 100,000/μL

- Creatinine ≤ 1.5 x upper limit of normal (ULN)

- AST < 2 x ULN

- Bilirubin ≤ ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception


- No prior chemotherapy or radiotherapy for NSCLC

- At least 2 weeks since formal exploratory thoracotomy

- No concurrent administration of sucralfate suspension and erlotinib hydrochloride

- No concurrent intensity-modulated radiotherapy

- No concurrent hormones or other chemotherapeutic agents except steroids given for
adrenal failure, hormones administered for non-disease-related conditions (e.g.,
insulin for diabetes), and intermittent use of dexamethasone as an antiemetic

- No concurrent palliative radiotherapy

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival at 12 months

Safety Issue:


Principal Investigator

Rogerio C. Lilenbaum, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cleveland Clinic Florida - Weston


United States: Federal Government

Study ID:




Start Date:

March 2008

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • adenocarcinoma of the lung
  • bronchoalveolar cell lung cancer
  • large cell lung cancer
  • squamous cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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