Clinical Trial 18428

Cancer Type: Thoracic
Interventions:Crizotinib; Erlotinib; Paraplatin (carboplatin); Tarceva (Erlotinib); Taxol (paclitaxel); Xalkori (Crizotinib); carboplatin; cisplatin; etoposide; paclitaxel

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Thomas Dilling

Overview

Study Title

A Randomized Phase II Study of Individualized Combined Modality Therapy for Stage III Non-Small Cell Lung Cancer (NSCLC)

Summary

The purpose of this study is to find out what effects, good and/or bad, one of the following treatments has on participants and their locally advanced, non-operable lung cancer with specific gene alterations (EGFR mutation or ALK rearrangement).

Objective

Primary Objective: To assess whether patients with unresectable local-regionally advanced NSCLC treated with targeted agents based on molecular characteristics have a longer progression-free survival than those treated with standard care therapy alone. Secondary Objectives: To evaluate response rate; to assess toxicity; to assess overall survival; to correlate clinical outcomes with tumor molecular aberrations identified from deep sequencing of selected kinomes in patients from whom adequate baseline tissue is available.

Inclusion Criteria

  • Age 18 years or older
  • Histologically or cytologically confirmed, newly diagnosed non-squamous Non-small Cell Lung Cancer (NSCLC)
  • Unresectable stage IIIA or IIIB disease; must be surgically staged to confirm N2 or N3 disease; may have invasive mediastinal staging by mediastinoscopy, mediastinotomy, endobronchial ultrasound transbronchial aspiration (EBUS-TBNA), endoscopic ultrasound (EUS), or video-assisted thoracoscopic surgery (VATS)
  • Potential participants with any tumor (T) with node (N)2 or N3 are eligible; patients with T3, N1-N3 disease are eligible if deemed unresectable; patients with T4, any N are eligible
  • Must have measurable disease, i.e., lesions that can be accurately measured in at least 1 dimension (longest dimension in the plane of measurement is to be recorded) with a minimum size of 10 mm by computed tomography (CT) scan (CT scan slice thickness no greater than 5 mm)
  • Patients with a pleural effusion, which is a transudate, cytologically negative and non-bloody, are eligible if the radiation oncologist feels the tumor can be encompassed within a reasonable field of radiotherapy
  • If a pleural effusion can be seen on the chest CT but not on chest x-ray and is too small to tap, the patient will be eligible; participants who develop a new pleural effusion after thoracotomy or other invasive thoracic procedure will be eligible
  • Zubrod performance status 0-1 within 14 days prior to registration
  • Adequate bone marrow, hepatic and renal function
  • Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential
  • Must provide study specific informed consent prior to study entry, including consent for mandatory screening of tissue
  • Additional criteria may apply

  • Exclusion Criteria

  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 730 days (2 years) (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
  • Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Atelectasis of the entire lung
  • Contralateral hilar node involvement
  • Exudative, bloody, or cytologically malignant effusions
  • Severe, active co-morbidity, defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; Transmural myocardial infarction within the last 6 months; Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immuno-compromised patients.
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
  • Prior allergic reaction to the study drug(s) involved in this protocol