Non-Small Cell Lung CancerPhase 1NEORADJUVANTNCT06800339
A Study Evaluating Neoadjuvant Chemoimmunotherapy With Immunosensitizing Radiation for Borderline Resectable Non-Small Cell Lung Cancer
A Phase 1 study testing Nivolumab, Chemotherapy and SBRT in people with Non-Small Cell Lung Cancer, run by University of Maryland, Baltimore at 4 sites in United States.
Trial summary
The purpose of this research study is to find out if adding radiation prior to chemoimmunotherapy and surgery is effective for people with non-small cell lung cancer (NSCLC) who have the potential for surgery. Standard of Care Chemoimmunotherapy: For this study, standard of care chemotherapy will be used. 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?
- Nivolumab, Chemotherapy and SBRT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 4 sitesUnited States
- Study dates
- 22 Apr 2025to Mar 2030
- Phase
- Phase 1
- 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
- Age greater than or equal to18 years at time of study entry
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1
- Participants with histologically confirmed stage II-IIIC(N3) NSCLC (per the 8th International Association for the Study of Lung Cancer) with disease that is considered borderline resectable prior to initiation of RT or systemic therapy.
- Patients with intrathoracic, contralateral N3 disease will be allowed to enroll (see exclusion criteria for further details)
- Subject cases must be reviewed in a multidisciplinary thoracic tumor board setting prior to enrollment to allow for adequate discussion regarding the potential for resection.
- Participants must have a tumor tissue sample available for biomarker testing, including next-generation sequencing to confirm EGFR/ALK status. Assessment of EGFR/ALK status may be performed locally through a CLIA approved laboratory testing method.
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- Tissue source may be a formalin fixed paraffin block (FFPE) of a previous tumor biopsy sample. Source of biomarker testing may be obtained from archived tissue if adequate or from a new biopsy, if needed and clinically indicated
- Absence of major associated pathologies that increase the surgery risk to an unacceptable level
- Pulmonary function capacity (eg. FVC, FEV1, TLC, and DLCO) capable of tolerating proposed lung resection according to surgeon.
- Adequate normal organ and marrow function defined below:
- Platelet count greater than or equal to100,000/mm3
- Hemoglobin greater than or equal to 8 g/dL
- Absolute neutrophil count (ANC) greater than or equal to 1000/mm3
- Creatinine less than or equal to 1.5 x ULN or creatinine clearance (CrCl) greater than or equal to 40 mL/min
- Total bilirubin less than or equal to 1.5 x ULN (except subjects with Gilbert Syndrome who can have total bilirubin < 3.0 mg/dL)
- AST, ALT, Alkaline phosphatase less than or equal to 3 x ULN per local testing
- Subjects are deemed capable of giving informed consent and must have signed and dated an IRB approved written informed consent form. This written consent must be obtained before the performance of any protocol related procedures that are not part of normal standard of care.
- Women of childbearing potential (WOCBP) must have negative serum or urine pregnancy testing within 30 days of study start.
Who cannot join
- Presence of metastatic (Stage IV) disease, including malignancy pleural effusions.
- Participants with N3 disease involving ipsilateral or contralateral scalene or supraclavicular lymph nodes. In the case of clinical suspicion for involvement of these lymph nodes, pathologic confirmation and biopsy may be pursued to determine final eligibility.
- Participants with known sensitizing EGFR (L858R or Exon 19 deletion) mutations or ALK translocation. If testing is done, an FDA approved assay should be used and testing can be performed locally.
- Participants with brain metastases are excluded from this study. All patients should have pre-study MRI brain or CT head with contrast to confirm the absence of intracranial disease, per standard of care staging procedures.
- Participants with active autoimmune disease which would preclude immunotherapy. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of external trigger are permitted to enroll.
- Participants with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment. Inhaled or topical steroids, and adrenal replacement steroid doses >10 mg daily prednisone equivalent, are permitted in the absence of autoimmune disease.
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- Participants with serious or uncontrolled medical disorders.
- Participants with large-cell neuroendocrine carcinoma tumor histology.
- Prior administration of chemotherapy or any other cancer therapy for early-stage NSCLC.
- Prior therapy with an anti-PD-(L)1, anti-CTLA-4 antibody or any other antibody targeting t-cell co-regulatory pathways.
- Participants with active hepatitis B (positive hepatitis B surface antigen) or hepatitis C virus (positive HCV RNA).
- Participants with past HBV infection or resolved HBV infection (defined as the presence of hepatitis B core antibody and the absence of HBsAg) are eligible. HBV DNA must be obtained in these patients prior to randomization. HBV carriers or those participants requiring antiviral therapy are not eligible to participate.
- Participants positive for HCV antibody are eligible only if PCR is negative for HCV RNA.
- Participants with poorly controlled or untreated human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS). All of the following criteria are required to define an HIV infection that is well controlled and therefore eligible for enrollment: undetectable viral RNA, CD4 count greater than or equal to 350, no history of AIDS-defining opportunistic infection within the past 12 months, and stable for at least 4 weeks on the same anti-HIV medications.
- Active prior malignancy within the previous 3 years, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix or breast.
- History of allergy or hypersensitivity to nivolumab, or chemotherapy agents.
- History of allogeneic organ transplantation.
- Female patients who are pregnant or actively breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control methods from time of screening to 90 days after completion of surgery.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Maryland Proton Treatment Center
Baltimore, Maryland, 21201
Caitlin Eggleston, MPH, 4103287586, caitlineggleston@umm.edu
- Recruiting
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201
Caitlin Eggleston, MPH, 4103287586, caitlineggleston@umm.edu
- Recruiting
Upper Chesapeake- Kaufman Cancer Center
Bel Air, Maryland, 21014
Lalicia Roman, 443-643-1877, lalicia.roman@umm.edu
- Recruiting
Baltimore Washington Medical Center- Tate Cancer Center
Glen Burnie, Maryland, 21061
Pilar Strycula, 410-553-8110, p.strycula@umm.edu
About this study
Official title: A Phase I, Single-Arm, Single-Institution Study Evaluating Neoadjuvant Chemoimmunotherapy With Immunosensitizing Radiation for Borderline Resectable Non-Small Cell Lung Cancer
The purpose of this research study is to find out if adding radiation prior to chemoimmunotherapy and surgery is effective for people with non-small cell lung cancer (NSCLC) who have the potential for surgery.
Standard of Care Chemoimmunotherapy:
Read more
For this study, standard of care chemotherapy will be used. This means this is the type of chemotherapy that is normal for your cancer. In addition to the chemotherapy, you will also receive the immunotherapy drug, nivolumab. This will be administered intravenously once every 3 weeks for up to 3 cycles (i.e. 9 weeks of total systemic therapy), prior to surgical resection assessment. This combination is made up of the chemotherapy drugs carboplatin or cisplatin along with pemetrexed, paclitaxel or gemcitabine, and the immunotherapy drug is nivolumab. The chemotherapy is used to kill cancer cells, and the immunotherapy enables your immune system to attack cancer cells.
Stereotactic Body Radiation Therapy (SBRT) SBRT is when radiation is delivered at higher doses over a smaller period of time. For this study, you will receive three doses of radiation delivered every other day, for three total days. The final dose of radiation will happen within 7 days of starting chemoimmunotherapy.
You will be followed for up to 100 days following your last chemoimmunotherapy dose to monitor for potential side effects. Following this you will continue with your standard follow up with your doctor. During the standard follow-up time, study staff will review your charts to see if there have been any new updates with your cancer following treatment so they can tell how this treatment affects how long patients live and whether it helps avoid recurrence of the cancer.
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Radiation Treatment, SBRT, ChemoImmunotherapy
- 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.
NivolumabDrug
This will be administered intravenously once every 3 weeks for up to 3 cycles (i.e. 9 weeks of total systemic therapy)
ChemotherapyDrug
Chemotherapy options include: carboplatin or cisplatin along with pemetrexed, paclitaxel or gemcitabine
SBRTRadiation
Three fractions of radiation delivered every other day, for three total days. The final dose of radiation will happen within 7 days of starting chemoimmunotherapy
Surgical ResectionProcedure or surgery
Post treatment patient will be evaluated for surgical resection
| Study group | Role | What they receive |
|---|---|---|
| SBRT+Chemoimmunotherapy +/-Surgery | Experimental | Standard of care chemotherapy along with nivolumab. Nivolumab will be infused every 3 weeks for up to 3 cycles. Chemotherapy options include: carboplatin or cisplatin along with pemetrexed, paclitaxel or gemcitabine. Concurrently patient will receive 3 fractions of SBRT. Patient will then be evaluated for possible surgical resection. Receives: Drug: Nivolumab; Drug: Chemotherapy; Radiation: SBRT; Procedure: Surgical Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability of Adding Sub-ablative, Immunosensitizing, Radiotherapy to Standard of Care Neoadjuvant Chemoimmunotherapy
Evaluate the tolerability of adding sub-ablative, immunosensitizing, radiotherapy to standard of care neoadjuvant chemoimmunotherapy prior to surgery for resectable NSCLC, measured by the rate of DLTs from time of neoadjuvant therapy initiation to start of definitive therapy (either surgery or chemoimmunotherapy initiation).
Measured: 20 weeks post initiation of neoadjuvant therapy
Secondary outcomes (4)
Number of adverse events assessment by CTCAE v5.0 that are related to treatment
Determine the safety of adding sub-ablative, immunosensitizing, radiotherapy to standard of care neoadjuvant chemoimmunotherapy prior to definitive resection for resectable NSCLC, measured by the frequency of drug related adverse events, including serious adverse events, occurring up to the initiation of definitive therapy (either surgery or chemoimmunotherapy initiation). Safety will be measured by the frequency of drug related adverse events, including serious adverse events (defined by CTCAE version 5), occurring up until the time of definitive therapy initiation (either surgery or chemoradiotherapy).
Measured: 20-22 weeks post initiation of neoadjuvant therapy
Pathologic Complete Response Rate (pCR)
Estimate the rate of pathologic complete response after adding immunosensitizing radiotherapy to neoadjuvant chemoimmunotherapy prior to definitive resection. pCR is defined as lack of any viable tumor cells after complete evaluation in the resected lung cancer specimen and all sampled regional lymph nodes as determined by central pathology review and described by IASLC 2020 assessment criteria. The measure of interest is the proportion of resected patients with 0% residual viable tumor cells within all resected tissue as assessed by the central pathology review.
Measured: 20-22 weeks post initiation of neoadjuvant therapy
Major Pathologic Response Rate (MPR)
Estimate the rate of major pathologic response after adding immunosensitizing radiotherapy to neoadjuvant chemoimmunotherapy prior to definitive resection. MPR is defined as ≤ 10% viable tumor cells in resected tumor after complete evaluation in the resected lung cancer specimen as determined by central pathology review and described by IASLC 2020 assessment criteria. The measure of interest is the proportion of resected patients with ≤ 10% residual viable tumor cells within all resected tissue as assessed by the central pathology review.
Measured: 20-22 weeks post initiation of neoadjuvant therapy
Measure rate of definitive resection
Establish the rate of definitive resection for patients with borderline resectable NSCLC treated with subablative radiotherapy followed by neoadjuvant chemoimmunotherapy.
Rate of definitive resection will be measured as the percentage of participants who undergo a complete R0 resection of their disease after receiving neoadjuvant subablative radiotherapy followed by chemoimmunotherapy out of all treated participants.
Measured: 1 year post completion of accrual
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start22 Apr 2025
- Primary completionMar 2028 (estimated)
- Study completionMar 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.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Ferris, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800339
- Sponsor's protocol ID
- HP-00112115
- Acronym
- NEORADJUVANT
- Status last verified
- May 2026
- First submitted
- 27 Jan 2025
- Last updated
- 6 May 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 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Arm, Single-Institution Study Evaluating Neoadjuvant Chemoimmunotherapy With Immunosensitizing Radiation for Borderline Resectable Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06800339
- Acronym / sponsor ID
- NEORADJUVANT / HP-00112115
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Radiation Treatment, SBRT, ChemoImmunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 30 Jan 2025 (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 this research study is to find out if adding radiation prior to chemoimmunotherapy and surgery is effective for people with non-small cell lung cancer (NSCLC) who have the potential for surgery.
Standard of Care Chemoimmunotherapy:
For this study, standard of care chemotherapy will be used. This means this is the type of chemotherapy that is normal for your cancer. In addition to the chemotherapy, you will also receive the immunotherapy drug, nivolumab. This will be administered intravenously once every 3 weeks for up to 3 cycles (i.e. 9 weeks of total systemic therapy), prior to surgical resection assessment. This combination is made up of the chemotherapy drugs carboplatin or cisplatin along with pemetrexed, paclitaxel or gemcitabine, and the immunotherapy drug is nivolumab. The chemotherapy is used to kill cancer cells, and the immunotherapy enables your immune system to attack cancer cells.
Stereotactic Body Radiation Therapy (SBRT) SBRT is when radiation is delivered at higher doses over a smaller period of time. For this study, you will receive three doses of radiation delivered every other day, for three total days. The final dose of radiation will happen within 7 days of starting chemoimmunotherapy.
You will be followed for up to 100 days following your last chemoimmunotherapy dose to monitor for potential side effects. Following this you will continue with your standard follow up with your doctor. During the standard follow-up time, study staff will review your charts to see if there have been any new updates with your cancer following treatment so they can tell how this treatment affects how long patients live and whether it helps avoid recurrence of the cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT+Chemoimmunotherapy +/-Surgery | Experimental | Drug: Nivolumab, Drug: Chemotherapy, Radiation: SBRT, Procedure: Surgical ResectionStandard of care chemotherapy along with nivolumab. Nivolumab will be infused every 3 weeks for up to 3 cycles. Chemotherapy options include: carboplatin or cisplatin along with pemetrexed, paclitaxel or gemcitabine. Concurrently patient will receive 3 fractions of SBRT. Patient will then be evaluated for possible surgical resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age greater than or equal to18 years at time of study entry
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1
- Participants with histologically confirmed stage II-IIIC(N3) NSCLC (per the 8th International Association for the Study of Lung Cancer) with disease that is considered borderline resectable prior to initiation of RT or systemic therapy.
- Subject cases must be reviewed in a multidisciplinary thoracic tumor board setting prior to enrollment to allow for adequate discussion regarding the potential for resection.
- Participants must have a tumor tissue sample available for biomarker testing, including next-generation sequencing to confirm EGFR/ALK status. Assessment of EGFR/ALK status may be performed locally through a CLIA approved laboratory testing method.
Key exclusion criteria (18 listed)
- Presence of metastatic (Stage IV) disease, including malignancy pleural effusions.
- Participants with N3 disease involving ipsilateral or contralateral scalene or supraclavicular lymph nodes. In the case of clinical suspicion for involvement of these lymph nodes, pathologic confirmation and biopsy may be pursued to determine final eligibility.
- Participants with known sensitizing EGFR (L858R or Exon 19 deletion) mutations or ALK translocation. If testing is done, an FDA approved assay should be used and testing can be performed locally.
- Participants with brain metastases are excluded from this study. All patients should have pre-study MRI brain or CT head with contrast to confirm the absence of intracranial disease, per standard of care staging procedures.
- Participants with active autoimmune disease which would preclude immunotherapy. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of external trigger are permitted to enroll.
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 |
|---|---|---|
| NivolumabThis will be administered intravenously once every 3 weeks for up to 3 cycles (i.e. 9 weeks of total systemic therapy) | Drug | SBRT+Chemoimmunotherapy +/-Surgery |
| ChemotherapyChemotherapy options include: carboplatin or cisplatin along with pemetrexed, paclitaxel or gemcitabine | Drug | SBRT+Chemoimmunotherapy +/-Surgery |
| SBRTThree fractions of radiation delivered every other day, for three total days. The final dose of radiation will happen within 7 days of starting chemoimmunotherapy | Radiation | SBRT+Chemoimmunotherapy +/-Surgery |
| Surgical ResectionPost treatment patient will be evaluated for surgical resection | Procedure or surgery | SBRT+Chemoimmunotherapy +/-Surgery |
Primary outcome
Tolerability of Adding Sub-ablative, Immunosensitizing, Radiotherapy to Standard of Care Neoadjuvant Chemoimmunotherapy
Time frame: 20 weeks post initiation of neoadjuvant therapy
Evaluate the tolerability of adding sub-ablative, immunosensitizing, radiotherapy to standard of care neoadjuvant chemoimmunotherapy prior to surgery for resectable NSCLC, measured by the rate of DLTs from time of neoadjuvant therapy initiation to start of definitive therapy (either surgery or chemoimmunotherapy initiation).
4 secondary outcomes
Number of adverse events assessment by CTCAE v5.0 that are related to treatment
Time frame: 20-22 weeks post initiation of neoadjuvant therapy
Pathologic Complete Response Rate (pCR)
Time frame: 20-22 weeks post initiation of neoadjuvant therapy
Major Pathologic Response Rate (MPR)
Time frame: 20-22 weeks post initiation of neoadjuvant therapy
Measure rate of definitive resection
Time frame: 1 year post completion of accrual
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 6 May 2026.
- 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nivolumab, Chemotherapy and SBRT in people with Non-Small Cell Lung Cancer, run by University of Maryland, Baltimore at 4 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 18 inclusion and 18 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 6 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 4 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 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.
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 Matthew Ferris, MD (410-328-6080, matthew.ferris@umm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability of Adding Sub-ablative, Immunosensitizing, Radiotherapy to Standard of Care Neoadjuvant Chemoimmunotherapy (time frame: 20 weeks post initiation of neoadjuvant therapy). 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 6 May 2026.