ClinicalTrials.gg
RecruitingNCT06498635Updated Nov 6, 2026

Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial

A Phase 3 interventional study of Biospecimen Collection and Computed Tomography in Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8 and Stage IIIA Lung Cancer AJCC v8, sponsored by National Cancer Institute (NCI). Recruiting at 284 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by National Cancer Institute (NCI) · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 7 months later.
Updated Nov 6, 2026Site recruiting status changed5 sites addedGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
306
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 94 studies testing durvalumab in Carcinoma, Non-Small-Cell Lung — 16 open to participants now, 37 under way, 11 of them phase 3. durvalumab · Carcinoma, Non-Small-Cell Lung.

Planned enrollment
20th of 94
306 · median 74
Started
2025
with 2 others
Phase 3
17 of 94
3 open now
Primary completion
2039-07
later than 36 of 36 live
Registered
89th of 94
by date
Lead sponsor
3 of 94
National Cancer Institute (NCI)

Among the 94 studies testing durvalumab in Carcinoma, Non-Small-Cell Lung, this one is the 20th largest by planned enrollment, is one of 3 that started in 2025, is one of 17 in phase 3, reaches primary completion later than 36 of the 36 other live ones, and was the 89th registered.

How this study gives durvalumab

On this site’s reading of the record, durvalumab is the treatment under test here. Read study by study →

By phase

94 studies; the count open now beside each. This study's row is marked.

Phase 258 · 11 open
Phase 3this study17 · 3 open
Phase 113 · 1 open
Phase 1/24 · 0 open
Phase 42 · 1 open

By the year they started

First in 2013; this study’s year is marked. 3 started in 2025.

Size and results

Median enrollment 74 across the 94 interventional studies. Of the 47 that completed or were terminated, 27 (57%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 94 studies testing durvalumab in Carcinoma, Non-Small-Cell Lung, or all of them as a file.
02

Study summary

This phase III trial compares durvalumab to the usual approach (patient observation) after surgery for the treatment of patients with early-stage non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The usual approach for patients who are not in a study is to closely watch a patient's condition after surgery and to have regular visits with their doctor to watch for signs of the cancer coming back. Usually, patients do not receive further treatment unless the cancer returns. This study will help determine whether this different approach with durvalumab is better, the same, or worse than the usual approach of observation. Giving durvalumab may help patients live longer and prevent early-stage non-small cell lung cancer from coming back as compared to the usual approach.

Read the detailed description

PRIMARY OBJECTIVE:

I. To compare disease free survival (DFS) in stage II-IIIB non-small cell lung cancer participants who achieved a pathologic complete response (pCR) following standard of care neoadjuvant chemo-immunotherapy and are randomized to adjuvant durvalumab (MEDI4736) versus surveillance.

SECONDARY OBJECTIVES:

I. To compare the overall survival (OS) between the arms. II. To evaluate the frequency and severity of toxicities of adjuvant durvalumab (MEDI4736).

III. To compare the event free survival (EFS) between the arms.

TRANSLATIONAL MEDICINE OBJECTIVE:

I. To bank specimens and images for additional future translational medicine studies.

QUALITY OF LIFE (QOL) PRIMARY OBJECTIVE:

I. To compare patient-reported quality of life (QOL) status between treatment arms at 6 months from randomization using the Functional Assessment of Cancer Therapy-Lung (FACT-L) Trial Outcome Index (TOI).

QOL SECONDARY OBJECTIVES:

I. To compare patient-reported QOL between treatment arms at 24 weeks (6 months) from randomization using the Functional Assessment of Cancer Therapy-Biologic Response Modifier (FACT-BRM) physical and mental subscale scores.

II. To compare longitudinal changes in global health status between treatment arms from randomization to 48 week (12 months) using the FACT-L TOI.

PATIENT REPORTED OUTCOMES-COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS (PRO-CTCAE) OBJECTIVE:

I. To compare participant-reported symptoms using selected PRO-CTCAE items between treatment arms such as rash, itching, skin dryness, numbness, and tingling.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive durvalumab intravenously (IV) over 60 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) and blood sample collection throughout the trial.

ARM II: Patients undergo active surveillance for 12 months on study. Patients undergo CT and blood sample collection throughout the trial.

After completion of study treatment, patients are followed up annually until 10 years from randomization.

03

Conditions studied

  • Lung Non-Small Cell Carcinoma
  • Stage II Lung Cancer AJCC v8
  • Stage IIIA Lung Cancer AJCC v8
  • Stage IIIB Lung Cancer AJCC v8
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Participants must have histologically or cytological confirmed diagnosis of clinical stage II-IIIB (excluding clinical N3 disease) non-small cell lung cancer (NSCLC)
  • Participants must have had a complete (R0) resection of NSCLC (with appropriate lymph node sampling as defined by the National Comprehensive Cancer Network [NCCN] guidelines) within 84 days (12 weeks) prior to randomization. Acceptable types of surgical resection are: lobectomy, sleeve resection, bi-lobectomy, or pneumonectomy. Wedge resection is not allowed.

    • Note the NCCN guidelines: N1 and N2 node resection and mapping is a routine component of lung cancer resections. It is recommended at a minimum one N1 and three N2 stations is sampled or complete lymph node dissection. Formal ipsilateral mediastinal lymph node dissection is indicated for participants undergoing resection for N2 disease
  • Participants must have a pathologic complete response (pCR) (no viable tumor in the resected specimen or lymph nodes), as determined by local pathology review
  • Participants must have a status result (e.g. [\< 1% versus >= 1% or unknown])
  • Participants must not have known EGFR mutations, or ALK gene fusion
  • Participants must have received at least two cycles of platinum-based chemotherapy and anti-PD-1 or anti-PD-L1 therapy. The neoadjuvant treatment must be Food and Drug Administration (FDA) approved and standard of care as listed in NCCN guidelines
  • Participants must not be planning to receive any concurrent non-protocol directed chemotherapy, immunotherapy, biologic or hormonal therapy for NSCLC treatment while receiving treatment on this study
  • Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or drug) within 28 days prior to randomization
  • Participants must not have medical or severe adverse events to receiving anti-PD-1 or anti-PD-L1 therapy
  • Participants must not have received post-operative radiation therapy (PORT) for NSCLC
  • Participants must not have any unresolved toxicity National Cancer Institute (NCI) grade ≥ 2 from previous anticancer therapy with the exception of alopecia, and vitiligo. Note, participants with grade ≥2 neuropathy may be included at the discretion of the treating investigator. Note, participants with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included at the discretion of the treating investigator
  • Participant must be ≥ 18 years old at time of study entry
  • Participants must have body weight > 30 kg
  • Participant must have Zubrod performance status of 0-2
  • Participant must have a complete medical history and physical exam within 28 days prior to randomization
  • > 9.0 g/dL (within 28 days prior to randomization)
  • ≥ 1.5 x 10\^3/uL (within 28 days prior to randomization)
  • ≥ 100 x 10\^3/uL (within 28 days prior to randomization)
  • Total ≤ 1 x institutional (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN (within 28 days prior to randomization)
  • (AST)/alanine transaminase (ALT) ≤ 3 × institutional ULN (within 28 days prior to randomization)
  • Participants must have a calculated ≥ 40 mL/min using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 28 days prior to randomization. For creatinine clearance formula see the tools on the Clinical Research Associate (CRA) Workbench https://txwb.crab.org/TXWB/Tools.aspx
  • Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator
  • Participants with a known history of (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to randomization
  • Participants with a known history of chronic virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to randomization, if indicated
  • Participants with a known history of virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to randomization, if indicated
  • Participants must not have had an organ transplant
  • Participants must not have a prior or concurrent whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen
  • Participant must not have medical contraindications to receiving immunotherapy, including history of non-infectious pneumonitis that required or active disease that has required systemic treatment with disease modifying agents, corticosteroids or drugs in the past two years. Replacement therapy (e.g. thyroxine for pre-existing hypothyroidism, insulin for type I diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Intra-articular steroid injections are allowed
  • Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of must have agreed to use an effective method during protocol therapy and for 6 months following completion of protocol therapy with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen. Participants should not breastfeed during protocol therapy and for 6 months following completion of protocol therapy
  • Participants must not have received a live or within 28 days prior randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever rabies, Bacillus Calmette-Guerin (BCG) and typhoid vaccine. Seasonal influenza vaccines and coronavirus disease 19 (COVID-19) vaccines are allowed, however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated, and are not allowed
  • Participants must be offered the opportunity to participate in specimen banking
  • Participants who can complete FACT-L, FACT-BRM, and PRO-CTCAE questionnaires forms in English, or Spanish must agree to participate in the patient-reported outcome study
  • NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
  • Participants must be informed of the investigational nature of this study and must sign and give in accordance with institutional and federal guidelines
  • For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
Terms in these criteria, in plain language(23)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
306 participants (estimated)

Study arms

  • Experimental
    Arm I (durvalumab)

    Patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT and blood sample collection throughout the trial.

    Procedure: Biospecimen Collection · Procedure: Computed Tomography · Biological: Durvalumab · Other: Questionnaire Administration

  • Active comparator
    Arm II (active surveillance)

    Patients undergo active surveillance for 12 months on study. Patients undergo CT and blood sample collection throughout the trial.

    Procedure: Biospecimen Collection · Procedure: Computed Tomography · Other: Patient Observation · Other: Questionnaire Administration

Interventions

  • ProcedureBiospecimen Collection

    Undergo blood sample collection

    Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

  • ProcedureComputed Tomography

    Undergo CT

    Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

  • BiologicalDurvalumab

    Given IV

    Also known as: Imfinzi, Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer, MEDI 4736, MEDI-4736, MEDI4736

  • OtherPatient Observation

    Undergo active surveillance

    Also known as: Active Surveillance, deferred therapy, expectant management, Observation, Watchful Waiting

  • OtherQuestionnaire Administration

    Ancillary studies

06

What researchers measure

Primary outcomes

  1. Disease-free survival (DFS)

    Will be assessed using a 1-sided 5% level log-rank test accounting for interim testing, stratified on the randomization stratification factors.

    Time frame: From date of randomization to the earliest event defined as date of first documentation of recurrence, any new lung cancer (even in the contralateral lung), or death due to any cause, assessed up to 10 years

Secondary outcomes

  1. Event-free survival (EFS)

    EFS events are defined as: Discontinuation of durvalumab (MEDI4736) due to toxicity, either immune or non-immune related, any new lung cancer (even in the contralateral lung), the use of glucocorticoids for \> 14 days for the treatment of toxicity secondary to durvalumab (MEDI4736), hospitalization due to toxicity from durvalumab (MEDI4736), disease recurrence, or death due to any cause. Will be estimated using the method of Kaplan-Meier. 95% confidence for the medians will be constructed using the method of Brookmeyer-Crowley. Hazard ratios (HRs) and corresponding 90% confidence intervals (CI) will be estimated using a Cox proportional hazards model with treatment arm as a single covariate. EFS will be compared between treatment arms using log-rank test, stratified on the randomization stratification factors.

    Time frame: From date of randomization to date of first occurrence of EFS event, assessed up to 10 years

  2. Overall survival (OS)

    Will be estimated using the method of Kaplan-Meier. 95% confidence for the medians will be constructed using the method of Brookmeyer-Crowley. HRs and corresponding 90% CI will be estimated using a Cox proportional hazards model with treatment arm as a single covariate. OS will be compared between treatment arms using log-rank test, stratified on the randomization stratification factors.

    Time frame: From date of randomization to date of death due to any cause, assessed up to 10 years

  3. Incidence of adverse events

    Will be evaluated using the Common Terminology Criteria for Adverse Events version 5 items. Binary proportions and associated confidence intervals will be calculated.

    Time frame: Up to 10 years

Other outcomes

  1. Patient reported outcomes

    Will be assessed by Patient Reported Outcomes - Common Terminology Criteria for Adverse Events (PRO-CTCAE) instrument(s). For each of the PRO-CTCAE adverse events examined, the scores for each attribute (frequency, severity and/or interference) will be presented descriptively using summary statistics at each assessment time. Additionally, the worst severity and/or interference over the entire course will be summarized.

    Time frame: Up to 10 years

  2. Estimates of the primary outcome treatment effect

    The hazard ratio of DFS and the corresponding 95% CIs will be estimated for subgroups defined by sex, race and ethnicity, respectively.

    Time frame: Up to 10 years

07

Study locations

279 of 284 sites recruiting

Showing the first 100 of 284 sites. Choose a country and city above to see the rest.

08

References and documents

Publications

  • Osarogiagbon RU, Cetnar JP, Aljumaily R. Optimal Use of Targeted Therapy and Immunotherapy in Early-Stage, Resectable Non-Small Cell Lung Cancer. Am Soc Clin Oncol Educ Book. 2026 Jun;46(3):e518244. doi: 10.1200/EDBK-26-518244. Epub 2026 Jun 23. PubMed 42335416 ↗

Individual participant data

Plan to share: Yes — NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Data sharing details ↗ · grants.nih.gov

09

Updates

11 registry updates since Sep 25, 2026
Sites
5 sites added. 6 sites changed recruiting status (4 now recruiting, 1 now active, not recruiting, …)
Show 6 sites
  • Roswell Park Cancer Institute · Buffalo, United StatesRecruiting→Active, not recruiting
  • Upper Valley Medical Center · Troy, United StatesSuspended→Recruiting
  • Providence Hood River Memorial Hospital · Hood River, United StatesSuspended→Recruiting
  • Providence Newberg Medical Center · Newberg, United StatesSuspended→Recruiting
  • Providence Willamette Falls Medical Center · Oregon City, United StatesSuspended→Recruiting
  • Duke Cancer Center Cary · Cary, United StatesRecruiting→Suspended
Show 5 added (5 United States)
  • Henry Ford Macomb Hospital-Clinton Township · Clinton Township, United States
  • Johns Hopkins University/Sidney Kimmel Cancer Center · Baltimore, United States
  • MUSC Hematology-Oncology at Murrells Inlet · Murrells Inlet, United States
  • Mercy Hospital · Cedar Rapids, United States
  • Oncology Associates at Mercy Medical Center · Cedar Rapids, United States
across 11 updates, Sep 25, 2026 – Nov 6, 2026
Site contacts
Changed at 12 sites. See the sites
Show 12 sites
  • Roswell Park Cancer Institute · Buffalo, United StatesContact removed a•••@roswellpark.org · •••9355Contact removed (no phone or email listed)
  • Loyola University Medical Center · Maywood, United StatesContact added •••4357Contact added (no phone or email listed)
  • Baystate Medical Center · Springfield, United StatesContact added t•••@baystatehealth.org · •••3565Contact added (no phone or email listed)
  • Aultman Health Foundation · Canton, United StatesContact added C•••@aultman.com · •••7274Contact added (no phone or email listed)
  • Providence Portland Medical Center · Portland, United StatesContact added C•••@providence.org · •••2614Contact added (no phone or email listed)
  • Providence Saint Vincent Medical Center · Portland, United StatesContact added C•••@providence.org · •••2614Contact added (no phone or email listed)
  • Upper Valley Medical Center · Troy, United StatesContact added c•••@daytonncorp.org · •••2900Contact added (no phone or email listed)
  • Providence Hood River Memorial Hospital · Hood River, United StatesContact added c•••@provdience.org · •••1979Contact added (no phone or email listed)
  • Providence Newberg Medical Center · Newberg, United StatesContact added C•••@providence.org · •••2614Contact added (no phone or email listed)
  • Providence Willamette Falls Medical Center · Oregon City, United StatesContact added C•••@providence.org · •••2614Contact added (no phone or email listed)
  • Bryn Mawr Hospital · Bryn Mawr, United StatesContact added t•••@mlhs.org · •••2649Contact added (no phone or email listed)
  • Duke Cancer Center Cary · Cary, United StatesContact removed N•••@dm.duke.eduContact removed (no phone or email listed)
across 8 updates, Sep 25, 2026 – Nov 6, 2026
Show all 11 updates
  1. Nov 6, 2026
    Duke Cancer Center Cary is now Suspended
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Duke Cancer Center Cary · Cary, United StatesContact removed N•••@dm.duke.eduContact removed (no phone or email listed)
  2. Nov 4, 2026
    2 sites added
    Show 2 added (2 United States)
    • Mercy Hospital · Cedar Rapids, United States
    • Oncology Associates at Mercy Medical Center · Cedar Rapids, United States
  3. Nov 3, 2026
    Bryn Mawr Hospital is now Recruiting
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Bryn Mawr Hospital · Bryn Mawr, United StatesContact added t•••@mlhs.org · •••2649Contact added (no phone or email listed)
  4. Nov 2, 2026
    1 site added. Bryn Mawr Hospital is now Suspended
    Show site
    • MUSC Hematology-Oncology at Murrells Inlet · Murrells Inlet, United States
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Bryn Mawr Hospital · Bryn Mawr, United StatesContact removed t•••@mlhs.org · •••2649Contact removed (no phone or email listed)
  5. Oct 19, 2026
    1 site added
    Show site
    • Johns Hopkins University/Sidney Kimmel Cancer Center · Baltimore, United States
  6. Oct 15, 2026
    6 sites changed recruiting status (6 now recruiting)
    Show 6 sites
    • Baystate Medical Center · Springfield, United StatesSuspended→Recruiting
    • Providence Hood River Memorial Hospital · Hood River, United StatesSuspended→Recruiting
    • Providence Newberg Medical Center · Newberg, United StatesSuspended→Recruiting
    • Providence Willamette Falls Medical Center · Oregon City, United StatesSuspended→Recruiting
    • Providence Portland Medical Center · Portland, United StatesSuspended→Recruiting
    • Providence Saint Vincent Medical Center · Portland, United StatesSuspended→Recruiting
    Site contacts Changed at 6 sites. See the sites
    Show 6 sites
    • Baystate Medical Center · Springfield, United StatesContact added t•••@baystatehealth.org · •••3565Contact added (no phone or email listed)
    • Providence Hood River Memorial Hospital · Hood River, United StatesContact added c•••@provdience.org · •••1979Contact added (no phone or email listed)
    • Providence Newberg Medical Center · Newberg, United StatesContact added C•••@providence.org · •••2614Contact added (no phone or email listed)
    • Providence Willamette Falls Medical Center · Oregon City, United StatesContact added C•••@providence.org · •••2614Contact added (no phone or email listed)
    • Providence Portland Medical Center · Portland, United StatesContact added C•••@providence.org · •••2614Contact added (no phone or email listed)
    • Providence Saint Vincent Medical Center · Portland, United StatesContact added C•••@providence.org · •••2614Contact added (no phone or email listed)
  7. Oct 7, 2026
    2 sites changed recruiting status (2 now recruiting)
    Show 2 sites
    • Aultman Health Foundation · Canton, United StatesSuspended→Recruiting
    • Upper Valley Medical Center · Troy, United StatesSuspended→Recruiting
    Site contacts Changed at 2 sites. See the sites
    Show 2 sites
    • Aultman Health Foundation · Canton, United StatesContact added C•••@aultman.com · •••7274Contact added (no phone or email listed)
    • Upper Valley Medical Center · Troy, United StatesContact added c•••@daytonncorp.org · •••2900Contact added (no phone or email listed)
  8. Oct 6, 2026
    5 sites changed recruiting status (4 now suspended, 1 now recruiting)
    Show 5 sites
    • Loyola University Medical Center · Maywood, United StatesSuspended→Recruiting
    • Baystate Medical Center · Springfield, United StatesRecruiting→Suspended
    • Aultman Health Foundation · Canton, United StatesRecruiting→Suspended
    • Providence Portland Medical Center · Portland, United StatesRecruiting→Suspended
    • Providence Saint Vincent Medical Center · Portland, United StatesRecruiting→Suspended
    Site contacts Changed at 5 sites. See the sites
    Show 5 sites
    • Loyola University Medical Center · Maywood, United StatesContact added •••4357Contact added (no phone or email listed)
    • Baystate Medical Center · Springfield, United StatesContact removed t•••@baystatehealth.org · •••3565Contact removed (no phone or email listed)
    • Aultman Health Foundation · Canton, United StatesContact removed C•••@aultman.com · •••7274Contact removed (no phone or email listed)
    • Providence Portland Medical Center · Portland, United StatesContact removed C•••@providence.org · •••2614Contact removed (no phone or email listed)
    • Providence Saint Vincent Medical Center · Portland, United StatesContact removed C•••@providence.org · •••2614Contact removed (no phone or email listed)
    + 1 other change: verification date
  9. Oct 1, 2026
    Loyola University Medical Center is now Suspended
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Loyola University Medical Center · Maywood, United StatesContact removed •••4357Contact removed (no phone or email listed)
  10. Sep 29, 2026
    1 site added
    Show site
    • Henry Ford Macomb Hospital-Clinton Township · Clinton Township, United States
  11. Sep 25, 2026
    Roswell Park Cancer Institute is now Active, not recruiting
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Roswell Park Cancer Institute · Buffalo, United StatesContact removed a•••@roswellpark.org · •••9355Contact removed (no phone or email listed)

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06498635
Responsible party
Sponsor
First posted
Jul 12, 2024
Start date
Apr 1, 2025
Primary completion
Jul 15, 2039 (estimated)
Completion
Jul 15, 2039 (estimated)
Last update
Nov 6, 2026

Study contacts

Jeremy P Cetnar
principal investigator · SWOG Cancer Research Network

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Durvalumab

Start the discussion