Personalized Adaptive Radiation Therapy With Individualized Systemic Targeted Therapy (PARTIST) for Locally Advanced, Non-small Cell Lung Cancer With Genomic Driver Mutations

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Hypotheses:

Short-term - Targeted therapy with erlotinib or crizotinib plus PART (Personalized Adaptive Radiation Therapy) will be safe and will yield favorable outcomes in patients with stage III, EGFR (Epidermal Growth Factor Receptor) + or ALK (Anaplastic Lymphoma Kinase) + NSCLC (Non-Small Cell Lung Cancer).

Long-term - In patients with stage III NSCLC harboring driver mutations, treatment with relevant targeted agents plus PART will improve both local-regional and systemic tumor control resulting in improved survival relative to standard chemoradiotherapy.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan Cancer Center; University of Michigan Rogel Cancer Center
• Collaborator: Augusta University
• Treatments: Crizotinib; Erlotinib Hydrochloride

Criteria

Inclusion Criteria:

• Patients with FDG-avid (radioactive glucose) and pathologically proven stage IIA-IIB or IIIA-IIIB non-small cell lung cancer (according to AJCC [American Joint Committee on Cancer] staging, 7th edition).

• Patients with tumors that harbor either EGFR sensitizing mutations or ALK rearrangement.

• Patients must be considered unresectable or medically inoperable; patients who decline surgery are also eligible.

• Patients must be 18 years of age or older.

• Patients with ECOG (Eastern Cooperative Oncology Group) performance status of 0-2.

• Patients must have adequate organ function.

• Patients must be able to take oral medications.

• Women with reproductive capability must be willing to use effective contraception.

• Patients must be informed of the investigational nature of this study and sign written informed consent in accordance with institutional and federal guidelines.

• Patients must be willing to comply with study procedures.

Exclusion Criteria:

• Patients with tumors that have a component of small cell carcinoma.

• Patients wtih stage I, II, or IV disease, including malignant pleural or pericardial effusion.

• Prior radiotherapy to the thorax such that composite radiation would significantly over-dose critical structures, either per estimation of the treating radiation oncologist or defined by failure to meet normal tissue tolerance constraints.

• Patients who cannot tolerate thoracic radiotherapy or targeted therapy.

• Patients wtih a prior diagnosis of interstitial lung disease or pulmonary fibrosis.

• Patients who cannot take oral medication, require intravenous alimentation, had prior surgical procedures affecting gastrointestinal absorption, or have active peptic ulcer disease.

• Hypersensitivity to erlotinib, crizotinib, or to any of the excipients.

• Pregnant women are excluded from this study because radiation has the potential for teratogenic or abortifacient effects.

• Prisoners are excluded from this study.