Non-small Cell Lung CancerPhase 1/2NCT04789486
Nano-SMART: Nanoparticles With MR Guided SBRT in Centrally Located Lung Tumors and Pancreatic Cancer
A Phase 1/2 study testing AGuIX and Radiotherapy in people with Non-small Cell Lung Cancer and Advanced Pancreatic Adenocarcinoma, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
This research study is being done to help determine the safety and efficacy of gadolinium based nanoparticle, Activation and Guidance of Irradiation X (AGuIX), used in conjunction with MR-guided stereotactic body radiation therapy (SBRT) in the treatment of pancreatic cancer and lung tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Advanced Pancreatic Adenocarcinoma, Unresectable Pancreatic Cancer
- What is being tested?
- AGuIX and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 May 2021to 10 Apr 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 should have clinical, radiographical, cytological, or histological confirmation of NSCLC or lung or nodal metastases from another primary cancer defined as within or touching the zone of the proximal bronchial tree, defined as a volume 2 cm in all directions around the trachea and proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus right and left lower lobe bronchi). Tumors that are immediately adjacent (<1 cm) to mediastinal or pericardial pleura or other radiation-sensitive organs such as the esophagus and brachial plexus also are considered central tumors and are eligible for this protocol.
- OR Histologically or cytologically confirmed pancreatic ductal adenocarcinoma of the pancreatic head, body or tail.
- Participants must have measurable disease, defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease.
- Eligible NSCLC patients must have no evidence of nodal involvement (N0), and disease has to be determined unresectable by a thoracic oncologist or the patient is medically inoperable.
- Locally advanced, unresectable pancreatic cancer as determined by a pancreaticobiliary surgeon as part of a multidisciplinary discussion at the investigative site, including multi-phasic CT demonstrating tumor abutment of the SMA or celiac axis, SMV or PV involvement which is not resectable without vascular reconstruction.
- Completion of at least 3 months of standard induction chemotherapy for LAPC, which should consist of either FOLFIRINOX, gemcitabine and nab-paclitaxel, or another standard combination of induction chemotherapy agent, with a washout period no longer than 10 weeks prior to first dose of study drug.
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- No evidence of distant metastasis.
- Pancreatic or central NSCLC size ≤ 5cm.
- Age 18 years or older.
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
- Ability to understand and follow the breathing instructions involved in the respiratory gating procedure.
- Participants must have normal organ and marrow function as defined below:
- absolute neutrophil count ≥1,500/mcL
- platelets ≥100,000/mcL
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
- creatinine within normal institutional limits OR
- Creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
- The effects of AGuIX on the developing human fetus are unknown. For this reason, as well as the known teratogenic effects of radiation, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Participants who have had prior radiation therapy to the chest or abdomen that would overlap with the current treatment field.
- Participants who are receiving any other investigational agents.
- Participants with known metastatic disease.
- History of allergic reactions attributed to gadolinium-based IV contrast.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because AGuIX is contrast agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with AGuIX, breastfeeding should be discontinued if the mother is treated with AGuIX.
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- Severe claustrophobia or anxiety.
- Known HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with AGuIX. In addition, these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.
- Active duodenal or gastric ulcer disease or evidence of tumor invasion of the bowel or stomach based on endoscopy.
- Presence of a duodenal stent.
- Unable to undergo magnetic resonance imaging (MRI) due to any of the following:
- Presence of MRI-incompatible metal material or devices in the human body
- MRI-incompatible Pacemaker or defibrillator
- Insulin pump
- Aneurysm clip
- Artificial heart valve
- Cochlear implant
- Shrapnel or gunshot injury
- Cataract surgery with implant unsafe for MRI
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Jonathan Leeman, MD, 6177326452, jonathe_leeman@dfci.harvard.edu
Jonathan Leeman, MD
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Jonathan Leeman, MD, 6177326452, jonathe_leeman@dfci.harvard.edu
Jonathan Leeman, MD
About this study
Official title: Nano-SMART: An Adaptive Phase I-II Trial of AGuIX Gadolinium-based Nanoparticles With Stereotactic Magnetic Resonance-guided Adaptive Radiation Therapy for Centrally Located Lung Tumors and Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma
This research study is being done to help determine the safety and efficacy of gadolinium based nanoparticle, Activation and Guidance of Irradiation X (AGuIX), used in conjunction with MR-guided stereotactic body radiation therapy (SBRT) in the treatment of pancreatic cancer and lung tumors.
Read the detailed description
This is a seamless phase I/II trial with two separate disease groups/cohorts (centrally located lung tumors and locally advanced/unresectable pancreatic ductal adenocarcinoma-LAPC). The Phase I part is determining for each disease group a safe dose-level that will be evaluated in the Phase II component of the study. The phase II part of the study is a randomized controlled trial that tests, for each disease group, the treatment efficacy of stereotactic body radiation therapy (SBRT) in combination with AGuIX gadolinium-chelated polysiloxane based nanoparticles compared to treatment with stereotactic magnetic resonance (MR)-guided adaptive radiation therapy (SMART) alone
The U.S. Food and Drug Administration (FDA) has not approved Activation and Guidance of Irradiation X (AGuIX) as a treatment for any disease.
AGuIX is a gadolinium-based nanoparticle, gadolinium is the drug used for an MR with contrast. It is believed that the AGuIX may help the radiation received work better by making a tumor more sensitive to the radiation and allowing doctors to see the tumor more clearly. AGuIX has been tested in one previous study with humans. It was found that AGuIX did make tumor cells more sensitive to radiation therapy.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
Participants will receive study treatment for 5 treatment days and will be followed for a year after your treatment ends.
It is expected that about 100 people will take part in this research study.
- Conditions
- Non-small Cell Lung Cancer, Advanced Pancreatic Adenocarcinoma, Unresectable Pancreatic Cancer, Ductal Adenocarcinoma of the Pancreas
- Being tested
- AGuIX, Radiotherapy
- Keywords
- Non-small Cell Lung Cancer, Advanced Pancreatic Adenocarcinoma, Unresectable Pancreatic Cancer, Ductal Adenocarcinoma of the Pancreas
- 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.
AGuIXDrug
Injected gadolinium-based nanoparticles
RadiotherapyRadiation
Stereotactic magnetic resonance-guided adaptive radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| AGUIX + SMART Phase 1 | Experimental | Dose escalation of Activation and Guidance of Irradiation X (AGUIX) and SMART, magnetic resonance imaging (MR)-guided stereotactic body radiation therapy (SBRT).
Central lung tumor cohort will receive:
* five fractions of stereotactic body radiation therapy (SBRT)
* AGuIX Nanoparticle given on -7 or -14 day prior to radiation treatment, then with 1st fraction of radiation and for patients receiving radiation over a two (2) week period with the 4th fraction of radiation .
Locally advanced/unresectable pancreatic ductal adenocarcinoma-LAPC cohort, will receive:
five fractions of stereotactic body radiation therapy (SBRT)
* AGuIX Nanoparticle given on -7 or -14 day prior to radiation treatment, then with 1st fraction of radiation. Receives: Drug: AGuIX; Radiation: Radiotherapy |
| AGUIX + SMART Phase 2 | Experimental | Randomized participants will receive recommended phase 1 dose established for their disease group (central lung tumor or locally advanced/unresectable pancreatic ductal adenocarcinoma-LAPC) of Activation and Guidance of Irradiation X (AGUIX) and SMART, magnetic resonance imaging (MR)-guided stereotactic body radiation therapy (SBRT). Receives: Drug: AGuIX; Radiation: Radiotherapy |
| SMART Phase 2 | Experimental | Randomized participants will receive standard of care SMART, magnetic resonance imaging (MR)-guided stereotactic body radiation therapy (SBRT). Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) Phase 1
Evaluated by the occurrence of Dose Limiting Toxicity (DLT) over the duration of the study using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: 3 months
Compare Local Control at 12 months of Maximum tolerated dose MTD - Phase 2
Evaluate SMART + AGuIX local control at 12 months compared to SMART alone. Local control at 12 months is defined as the treated tumor is equal to or less than the tumor volume at start of SMART. Progression would be defined per RECIST criteria
Measured: 12 months
Secondary outcomes (10)
Progression-free survival (PFS) at Maximum tolerated dose (MTD)
Assessed by RECIST criteria
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall Response Rate (ORR) at Maximum tolerated dose (MTD)
Assessed by RECIST criteria
Measured: Enrollment through study completion, an average of 1 year
Serious Adverse Events at 90 Days
NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be used.
Measured: 90 days
Serious Adverse Events at 12 months
NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be used.
Measured: 12 months
Tumor Changes
Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.
Measured: Enrollment through study completion, an average of 1 year
Compare disease-specific survival
Bayesian hierarchical two-sample test for binary outcomes
Measured: Enrollment through study completion, an average of 1 year
compare R0 resection rate
Bayesian hierarchical two-sample test for binary outcomes
Measured: Enrollment through study completion, an average of 1 year
Compare overall survival
Bayesian hierarchical two-sample test for binary outcomes
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Quality of Life (QoL)-Performance Status utilizing PROMIS Physical and Mental Health batteries
Described using descriptive statistics and longitudinal analyses
Measured: Baseline through study completion, an average of 1 year
Quality of Life (QoL)-Completion of Daily Activities utilizing PROMIS Physical and Mental Health batteries
Described using descriptive statistics and longitudinal analyses
Measured: Baseline through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start27 May 2021
- Primary completion10 Apr 2028 (estimated)
- Study completion10 Apr 2030 (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.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- TherAguix S.A.
- Responsible party
- Principal investigator, Jonathan Leeman, MD, Dana-Farber Cancer Institute
- Investigators
- Jonathan Leeman, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789486
- Sponsor's protocol ID
- 19-826
- Status last verified
- May 2026
- First submitted
- 3 Mar 2021
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nano-SMART: An Adaptive Phase I-II Trial of AGuIX Gadolinium-based Nanoparticles With Stereotactic Magnetic Resonance-guided Adaptive Radiation Therapy for Centrally Located Lung Tumors and Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT04789486
- Acronym / sponsor ID
- 19-826
- Conditions
- Non-small Cell Lung Cancer, Advanced Pancreatic Adenocarcinoma, Unresectable Pancreatic Cancer, Ductal Adenocarcinoma of the Pancreas
- Keywords
- Non-small Cell Lung Cancer, Advanced Pancreatic Adenocarcinoma, Unresectable Pancreatic Cancer, Ductal Adenocarcinoma of the Pancreas
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- TherAguix S.A.
- Study start
- 27 May 2021 (actual)
- Primary completion
- 10 Apr 2028 (estimated)
- Study completion
- 10 Apr 2030 (estimated)
- First posted
- 9 Mar 2021 (actual)
- 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.
This research study is being done to help determine the safety and efficacy of gadolinium based nanoparticle, Activation and Guidance of Irradiation X (AGuIX), used in conjunction with MR-guided stereotactic body radiation therapy (SBRT) in the treatment of pancreatic cancer and lung tumors.
Detailed description
This is a seamless phase I/II trial with two separate disease groups/cohorts (centrally located lung tumors and locally advanced/unresectable pancreatic ductal adenocarcinoma-LAPC). The Phase I part is determining for each disease group a safe dose-level that will be evaluated in the Phase II component of the study. The phase II part of the study is a randomized controlled trial that tests, for each disease group, the treatment efficacy of stereotactic body radiation therapy (SBRT) in combination with AGuIX gadolinium-chelated polysiloxane based nanoparticles compared to treatment with stereotactic magnetic resonance (MR)-guided adaptive radiation therapy (SMART) alone
The U.S. Food and Drug Administration (FDA) has not approved Activation and Guidance of Irradiation X (AGuIX) as a treatment for any disease.
AGuIX is a gadolinium-based nanoparticle, gadolinium is the drug used for an MR with contrast. It is believed that the AGuIX may help the radiation received work better by making a tumor more sensitive to the radiation and allowing doctors to see the tumor more clearly. AGuIX has been tested in one previous study with humans. It was found that AGuIX did make tumor cells more sensitive to radiation therapy.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
Participants will receive study treatment for 5 treatment days and will be followed for a year after your treatment ends.
It is expected that about 100 people will take part in this research study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AGUIX + SMART Phase 1 | Experimental | Drug: AGuIX, Radiation: RadiotherapyDose escalation of Activation and Guidance of Irradiation X (AGUIX) and SMART, magnetic resonance imaging (MR)-guided stereotactic body radiation therapy (SBRT). Central lung tumor cohort will receive: * five fractions of stereotactic body radiation therapy (SBRT) * AGuIX Nanoparticle given on -7 or -14 day prior to radiation treatment, then with 1st fraction of radiation and for patients receiving radiation over a two (2) week period with the 4th fraction of radiation . Locally advanced/unresectable pancreatic ductal adenocarcinoma-LAPC cohort, will receive: five fractions of stereotactic body radiation therapy (SBRT) * AGuIX Nanoparticle given on -7 or -14 day prior to radiation treatment, then with 1st fraction of radiation. |
| AGUIX + SMART Phase 2 | Experimental | Drug: AGuIX, Radiation: RadiotherapyRandomized participants will receive recommended phase 1 dose established for their disease group (central lung tumor or locally advanced/unresectable pancreatic ductal adenocarcinoma-LAPC) of Activation and Guidance of Irradiation X (AGUIX) and SMART, magnetic resonance imaging (MR)-guided stereotactic body radiation therapy (SBRT). |
| SMART Phase 2 | Experimental | Radiation: RadiotherapyRandomized participants will receive standard of care SMART, magnetic resonance imaging (MR)-guided stereotactic body radiation therapy (SBRT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patients should have clinical, radiographical, cytological, or histological confirmation of NSCLC or lung or nodal metastases from another primary cancer defined as within or touching the zone of the proximal bronchial tree, defined as a volume 2 cm in all directions around the trachea and proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus right and left lower lobe bronchi). Tumors that are immediately adjacent (<1 cm) to mediastinal or pericardial pleura or other radiation-sensitive organs such as the esophagus and brachial plexus also are considered central tumors and are eligible for this protocol.
- OR Histologically or cytologically confirmed pancreatic ductal adenocarcinoma of the pancreatic head, body or tail.
- Participants must have measurable disease, defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease.
- Eligible NSCLC patients must have no evidence of nodal involvement (N0), and disease has to be determined unresectable by a thoracic oncologist or the patient is medically inoperable.
- Locally advanced, unresectable pancreatic cancer as determined by a pancreaticobiliary surgeon as part of a multidisciplinary discussion at the investigative site, including multi-phasic CT demonstrating tumor abutment of the SMA or celiac axis, SMV or PV involvement which is not resectable without vascular reconstruction.
Key exclusion criteria (19 listed)
- Participants who have had prior radiation therapy to the chest or abdomen that would overlap with the current treatment field.
- Participants who are receiving any other investigational agents.
- Participants with known metastatic disease.
- History of allergic reactions attributed to gadolinium-based IV contrast.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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 |
|---|---|---|
| AGuIXInjected gadolinium-based nanoparticles | Drug | AGUIX + SMART Phase 1, AGUIX + SMART Phase 2 |
| RadiotherapyStereotactic magnetic resonance-guided adaptive radiation therapy | Radiation | AGUIX + SMART Phase 1, AGUIX + SMART Phase 2, SMART Phase 2 |
Primary outcome
Maximum tolerated dose (MTD) Phase 1
Time frame: 3 months
Evaluated by the occurrence of Dose Limiting Toxicity (DLT) over the duration of the study using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Compare Local Control at 12 months of Maximum tolerated dose MTD - Phase 2
Time frame: 12 months
Evaluate SMART + AGuIX local control at 12 months compared to SMART alone. Local control at 12 months is defined as the treated tumor is equal to or less than the tumor volume at start of SMART. Progression would be defined per RECIST criteria
10 secondary outcomes
Progression-free survival (PFS) at Maximum tolerated dose (MTD)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall Response Rate (ORR) at Maximum tolerated dose (MTD)
Time frame: Enrollment through study completion, an average of 1 year
Serious Adverse Events at 90 Days
Time frame: 90 days
Serious Adverse Events at 12 months
Time frame: 12 months
Tumor Changes
Time frame: Enrollment through study completion, an average of 1 year
Compare disease-specific survival
Time frame: Enrollment through study completion, an average of 1 year
compare R0 resection rate
Time frame: Enrollment through study completion, an average of 1 year
Compare overall survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Quality of Life (QoL)-Performance Status utilizing PROMIS Physical and Mental Health batteries
Time frame: Baseline through study completion, an average of 1 year
Quality of Life (QoL)-Completion of Daily Activities utilizing PROMIS Physical and Mental Health batteries
Time frame: Baseline through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Jonathan Leeman, MD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AGuIX and Radiotherapy in people with Non-small Cell Lung Cancer and Advanced Pancreatic Adenocarcinoma, run by Dana-Farber Cancer Institute at 2 sites 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 20 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Leeman, MD ((617) 732-6452, jonathe_leeman@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) Phase 1 (time frame: 3 months). 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 14 May 2026.