Nonsmall Cell Lung CancerEarly Phase 1NCT05873439
Genomically Guided Radiation Dose Personalization in Locally Advanced NSCLC
A Early Phase 1 study testing Genomically Guided Radiation Therapy (RT) in people with Nonsmall Cell Lung Cancer and Nonsmall Cell Lung Cancer, Stage II, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of the study is to determine the feasibility of genomically guided radiation therapy (RT) with concurrent chemotherapy in the management of stage II and III non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonsmall Cell Lung Cancer, Nonsmall Cell Lung Cancer, Stage II, Nonsmall Cell Lung Cancer Stage III
- What is being tested?
- Genomically Guided Radiation Therapy (RT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2023to 21 Aug 2024
- 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
- Diagnosis of AJCC Stage 2 or Stage 3 unresectable NSCLC as determined by a multidisciplinary oncology team
- Confirmation of NSCLC with availability of fresh tumor biopsy by tissue biopsy which can include adenocarcinoma, squamous cell, large cell carcinoma, or NSCLC not otherwise specified
- Life expectancy >12 weeks
- Normal renal (creatinine <1.5 × upper limit of normal [ULN]), liver (bilirubin < 1.5 × ULN, transaminases <3.0 × ULN, except in known hepatic disease, wherein may be <5 × ULN) and blood counts (white blood cells ≥2.5, neutrophils ≥1000, platelets ≥50, 000, hemoglobin ≥8)
- ECOG 0-1
- Age ≥ 18 years
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- Participants with surgery within 14 days should have recovered from all effects of the surgery and be cleared by their surgeon
- There is no limit on prior systemic or therapies
- Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study
- Ability to sign an informed consent form, which can be signed by a family member or health care proxy. Informed consent must be given before any study related procedures occur.
Who cannot join
- Current or prior participation in a study of an investigational agent or investigational device within 2 weeks of the first dose of study treatment
- Major surgery or significant traumatic injury that has not been recovered from 14 days before the initiation of study drug
- Women who are pregnant or breastfeeding
- History of allergy or hypersensitivity to any of the study drugs or study drug components
- Concurrent brain metastases or leptomeningeal disease
- History of prior malignancy within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS of > 90%), such as but not limited to, non-melanoma skin carcinoma, ductal carcinoma in situ, or stage I endometriod uterine cancer, and others at the discretion of the PI
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- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
- • Patients with vitiligo or alopecia
- • Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement
- • Any chronic skin condition that does not require systemic therapy
- • Patients without active disease in the last 5 years may be included but only after consultation with the Principal Investigator
- • Patients with celiac disease controlled by diet alone
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
- • Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection)
- • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
- • Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study of Genomically Guided Radiation Dose Personalization in the Management of Locally Advanced Non-Small Cell Lung Cancer
The purpose of the study is to determine the feasibility of genomically guided radiation therapy (RT) with concurrent chemotherapy in the management of stage II and III non-small cell lung cancer (NSCLC).
- Conditions
- Nonsmall Cell Lung Cancer, Nonsmall Cell Lung Cancer, Stage II, Nonsmall Cell Lung Cancer Stage III, Unresectable Non-Small Cell Lung Carcinoma
- Being tested
- Genomically Guided Radiation Therapy (RT)
- Keywords
- Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genomically Guided Radiation Therapy (RT)Radiation
Based on the Radiosensitivity Index (RSI) from testing participants tumor sample, participants will receive either standard dose radiation therapy, which is a strength 60Gy or up to 81Gy strength. Radiation treatment is administered 5 days per week for approximately 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: RSI predicts dose ≤ 60 Gy | Experimental | Participants will receive standard RT dose of 60Gy in 30 fractions targeting the primary tumor and any involved regional lymph nodes. Receives: Radiation: Genomically Guided Radiation Therapy (RT) |
| Arm B: RSI predicts dose > 60 Gy | Experimental | Participants will receive treatment with RxRSI guided boost to the primary tumor up to 81Gy (2.7Gy/fraction). Receives: Radiation: Genomically Guided Radiation Therapy (RT) |
| Arm C: unable to calculate RSI | Experimental | Participants in will receive standard RT dose of 60Gy in 30 fractions targeting the primary tumor and any involved regional lymph nodes. Receives: Radiation: Genomically Guided Radiation Therapy (RT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Unacceptable Toxicity
Rate of Unacceptable Toxicity will be measured during 12 week period following study enrollment. Unacceptable toxicity is defined as any grade 4 or 5 adverse event (AE) probably or definitely related to experimental dose escalated radiation therapy
Measured: 12 weeks after start of treatment
Secondary outcomes (2)
Freedom from local regional progression (FFLRP)
Freedom from local regional progression (FFLRP) will be defined as lack of progression as documented by response assessment imaging following completion of concurrent chemotherapy and radiation.
Measured: At 2 years
Overall Survival (OS)
Overall Survival (OS) will be measured from the date of first treatment to the date of death due to any cause.
Measured: At 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start25 May 2023
- Primary completion29 Nov 2023
- Study completion21 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonsmall Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Dilling, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873439
- Sponsor's protocol ID
- MCC 21525
- Status last verified
- Mar 2026
- First submitted
- 12 May 2023
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Genomically Guided Radiation Dose Personalization in the Management of Locally Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05873439
- Acronym / sponsor ID
- MCC 21525
- Conditions
- Nonsmall Cell Lung Cancer, Nonsmall Cell Lung Cancer, Stage II, Nonsmall Cell Lung Cancer Stage III, Unresectable Non-Small Cell Lung Carcinoma
- Keywords
- Lung Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 25 May 2023 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 21 Aug 2024 (actual)
- First posted
- 24 May 2023 (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.
The purpose of the study is to determine the feasibility of genomically guided radiation therapy (RT) with concurrent chemotherapy in the management of stage II and III non-small cell lung cancer (NSCLC).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: RSI predicts dose ≤ 60 Gy | Experimental | Radiation: Genomically Guided Radiation Therapy (RT)Participants will receive standard RT dose of 60Gy in 30 fractions targeting the primary tumor and any involved regional lymph nodes. |
| Arm B: RSI predicts dose > 60 Gy | Experimental | Radiation: Genomically Guided Radiation Therapy (RT)Participants will receive treatment with RxRSI guided boost to the primary tumor up to 81Gy (2.7Gy/fraction). |
| Arm C: unable to calculate RSI | Experimental | Radiation: Genomically Guided Radiation Therapy (RT)Participants in will receive standard RT dose of 60Gy in 30 fractions targeting the primary tumor and any involved regional lymph nodes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of AJCC Stage 2 or Stage 3 unresectable NSCLC as determined by a multidisciplinary oncology team
- Confirmation of NSCLC with availability of fresh tumor biopsy by tissue biopsy which can include adenocarcinoma, squamous cell, large cell carcinoma, or NSCLC not otherwise specified
- Life expectancy >12 weeks
- Normal renal (creatinine <1.5 × upper limit of normal [ULN]), liver (bilirubin < 1.5 × ULN, transaminases <3.0 × ULN, except in known hepatic disease, wherein may be <5 × ULN) and blood counts (white blood cells ≥2.5, neutrophils ≥1000, platelets ≥50, 000, hemoglobin ≥8)
- ECOG 0-1
Key exclusion criteria (16 listed)
- Current or prior participation in a study of an investigational agent or investigational device within 2 weeks of the first dose of study treatment
- Major surgery or significant traumatic injury that has not been recovered from 14 days before the initiation of study drug
- Women who are pregnant or breastfeeding
- History of allergy or hypersensitivity to any of the study drugs or study drug components
- Concurrent brain metastases or leptomeningeal disease
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 |
|---|---|---|
| Genomically Guided Radiation Therapy (RT)Based on the Radiosensitivity Index (RSI) from testing participants tumor sample, participants will receive either standard dose radiation therapy, which is a strength 60Gy or up to 81Gy strength. Radiation treatment is administered 5 days per week for approximately 6 weeks. | Radiation | Arm A: RSI predicts dose ≤ 60 Gy, Arm B: RSI predicts dose > 60 Gy, Arm C: unable to calculate RSI |
Primary outcome
Rate of Unacceptable Toxicity
Time frame: 12 weeks after start of treatment
Rate of Unacceptable Toxicity will be measured during 12 week period following study enrollment. Unacceptable toxicity is defined as any grade 4 or 5 adverse event (AE) probably or definitely related to experimental dose escalated radiation therapy
2 secondary outcomes
Freedom from local regional progression (FFLRP)
Time frame: At 2 years
Overall Survival (OS)
Time frame: At 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Moffitt Cancer Center Clinical Trial SearchLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Thomas Dilling, MD principal investigator
Moffitt 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 Genomically Guided Radiation Therapy (RT) in people with Nonsmall Cell Lung Cancer and Nonsmall Cell Lung Cancer, Stage II, run by H. Lee Moffitt Cancer Center and Research Institute 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 16 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: finished, as of the sponsor's last update on 1 Apr 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of Unacceptable Toxicity (time frame: 12 weeks after start of treatment). 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 1 Apr 2026.