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

NCT02277457 | Withdrawn Early Phase 1

• 2 other identifiers: UMCC 2014.117HUM00094166
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Time to Progression From the Initiation of Study Treatment For ALK + and EGFR + Patients

  5 Years

• Time to Death From Initiation of Study Treatment For ALK + and EGFR + Patients

  5 Years

Secondary Outcomes (2)

• The Number of Patients Experiencing Pneumonitis and Esophagitis

  5 Years

• The Number of Patients Experiencing Grade 3 or Higher Toxicities

  5 Years

Study Arms (2)

EGFR Mutation

EXPERIMENTAL

Patients with an identified EGFR mutation will receive PET (Positron Emission Tomography) - Adaptive RT (Radiation Therapy) plus concurrent Erlotinib followed by 1 year total of Erlotinib Treatment.

Radiation: PET-Adaptive RT; Drug: Erlotinib

ALK Rearrangement

EXPERIMENTAL

Patients with an identified EGFR mutation will receive PET (Positron Emission Tomography) - Adaptive RT (Radiation Therapy) plus concurrent Crizotinib followed by 1 year total ofCrizotinib Treatment.

Radiation: PET-Adaptive RT; Drug: Crizotinib

Interventions

PET-Adaptive RT RADIATION

All patients will be treated with response-driven PET-adaptive RT. The radiation dose will be delivered in greater than or equal to 2.2 Gy per daily fraction to FDG-PET/CT-guided target volumes with the treatment duration limited to 30 fractions and total radiation dose limited to 66-80.4 Gy.

ALK Rearrangement; EGFR Mutation

Erlotinib DRUG

150 mg once daily

EGFR Mutation

Crizotinib DRUG

250 mg twice daily

ALK Rearrangement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• Augusta University: collaborator

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48187, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride; Crizotinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Aminopyridines; Pyridines

Study Officials

• Gregory Kalemkerian, M.D.

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2014
• First Posted: October 29, 2014
• Study Start: September 1, 2015
• Primary Completion: June 1, 2021
• Last Updated: June 24, 2016

Record last verified: 2016-06

Locations

US (1)