Non-Small Cell Lung CancerEarly Phase 1NCT02277457
Personalized Adaptive Radiation Therapy With Individualized Systemic Targeted Therapy (PARTIST) for Locally Advanced, Non-small Cell Lung Cancer With Genomic Driver Mutations
A Early Phase 1 study testing PET-Adaptive RT, Erlotinib and Crizotinib in people with Non-Small Cell Lung Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- PET-Adaptive RT, Erlotinib and Crizotinib
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Jun 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48187
About this study
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.
Read the detailed description
The proposed trial is a pilot study that will accrue 30 patients with inoperable stage IIIA/B NSCLC harboring either an EGFR mutation (n=20) or an ALK rearrangement (n=10). Patients with EGFR+ tumors will be treated with erlotinib 150 mg orally QD; patients with ALK+ tumors will be treated with crizotinib 250 mg orally BID. Treatment consists of six weeks of concurrent PART plus erlotinib or crizotinib, followed by erlotinib or crizotinib for a total of 1 year. All patients will be treated with response-driven PART with dose intensified to the active (FDG-avid) region based on a mid-treatment FDG-PET/CT scan while maintaining dose limits for organs-at-risk. The primary endpoints will be PFS and OS. Primary analyses will be performed separately for ALK+ and EGFR+ patients. The secondary endpoint of treatment-related toxicity will focus on pneumonitis and esophagitis with a strict stopping rule in place.
Current standard therapy affords suboptimal outcomes for patients with locally advanced NSCLC due to both locoregional and distant recurrences. Since targeted therapy is more effective than chemotherapy in patients with relevant driver mutations, the best way to significantly improve outcomes in this subgroup of patients is to optimize systemic therapy with targeted agents while improving local control with PET-adapted, high-dose RT.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- PET-Adaptive RT, Erlotinib, Crizotinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-Adaptive RTRadiation
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.
ErlotinibDrug
150 mg once daily
CrizotinibDrug
250 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Radiation: PET-Adaptive RT; Drug: Crizotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Progression From the Initiation of Study Treatment For ALK + and EGFR + Patients
Measured: 5 Years
Time to Death From Initiation of Study Treatment For ALK + and EGFR + Patients
Measured: 5 Years
Secondary outcomes (2)
The Number of Patients Experiencing Pneumonitis and Esophagitis
Measured: 5 Years
The Number of Patients Experiencing Grade 3 or Higher Toxicities
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startSep 2015
- Primary completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Augusta University
- Responsible party
- Sponsor
- Investigators
- Gregory Kalemkerian, M.D., Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277457
- Sponsor's protocol ID
- UMCC 2014.117
- Other IDs
- HUM00094166
- Status last verified
- Jun 2016
- First submitted
- 24 Oct 2014
- Last updated
- 24 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Adaptive Radiation Therapy With Individualized Systemic Targeted Therapy (PARTIST) for Locally Advanced, Non-small Cell Lung Cancer With Genomic Driver Mutations
- ClinicalTrials.gov ID
- NCT02277457
- Acronym / sponsor ID
- UMCC 2014.117
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- Augusta University
- Study start
- Sep 2015
- Primary completion
- Jun 2021 (estimated)
- First posted
- 29 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The proposed trial is a pilot study that will accrue 30 patients with inoperable stage IIIA/B NSCLC harboring either an EGFR mutation (n=20) or an ALK rearrangement (n=10). Patients with EGFR+ tumors will be treated with erlotinib 150 mg orally QD; patients with ALK+ tumors will be treated with crizotinib 250 mg orally BID. Treatment consists of six weeks of concurrent PART plus erlotinib or crizotinib, followed by erlotinib or crizotinib for a total of 1 year. All patients will be treated with response-driven PART with dose intensified to the active (FDG-avid) region based on a mid-treatment FDG-PET/CT scan while maintaining dose limits for organs-at-risk. The primary endpoints will be PFS and OS. Primary analyses will be performed separately for ALK+ and EGFR+ patients. The secondary endpoint of treatment-related toxicity will focus on pneumonitis and esophagitis with a strict stopping rule in place.
Current standard therapy affords suboptimal outcomes for patients with locally advanced NSCLC due to both locoregional and distant recurrences. Since targeted therapy is more effective than chemotherapy in patients with relevant driver mutations, the best way to significantly improve outcomes in this subgroup of patients is to optimize systemic therapy with targeted agents while improving local control with PET-adapted, high-dose RT.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EGFR Mutation | Experimental | Radiation: PET-Adaptive RT, Drug: ErlotinibPatients 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. |
| ALK Rearrangement | Experimental | Radiation: PET-Adaptive RT, Drug: CrizotinibPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET-Adaptive RTAll 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. | Radiation | ALK Rearrangement, EGFR Mutation |
| Erlotinib150 mg once daily | Drug | EGFR Mutation |
| Crizotinib250 mg twice daily | Drug | ALK Rearrangement |
Primary outcome
Time to Progression From the Initiation of Study Treatment For ALK + and EGFR + Patients
Time frame: 5 Years
Time to Death From Initiation of Study Treatment For ALK + and EGFR + Patients
Time frame: 5 Years
2 secondary outcomes
The Number of Patients Experiencing Pneumonitis and Esophagitis
Time frame: 5 Years
The Number of Patients Experiencing Grade 3 or Higher Toxicities
Time frame: 5 Years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Kalemkerian, M.D. principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing PET-Adaptive RT, Erlotinib and Crizotinib in people with Non-Small Cell Lung Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Progression From the Initiation of Study Treatment For ALK + and EGFR + Patients (time frame: 5 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2016.