A Phase 2 interventional study of Durvalumab and Surgery in Stage IIIA Non-small Cell Lung Cancer and Stage IIIB Non-small Cell Lung Cancer, sponsored by Alliance Foundation Trials, LLC.. Active, not recruiting at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Alliance Foundation Trials, LLC. · Phase 2, Interventional, and Treatment
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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.
Among the 94 studies testing durvalumab in Carcinoma, Non-Small-Cell Lung, this one is the 63rd largest by enrollment, is one of 15 that started in 2021, is one of 58 in phase 2, reaches primary completion later than 11 of the 36 other live ones, and was the 47th registered.
7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →16 of the 94 studies testing durvalumab in Carcinoma, Non-Small-Cell Lung are open now, in 12 countries. Recruiting first, the newest first:
City of Hope Medical Center · Sites in United States
Ages 18+
AstraZeneca · Sites in Australia, Georgia, Poland and 2 more countries
Ages 18+
National Cancer Institute (NCI) · Sites in United States
Ages 18+
ETOP IBCSG Partners Foundation · Sites in Australia, Austria, Belgium and 7 more countries
Ages 18+
Idris Bahce · Sites in Netherlands
Ages 18+
By country, each count listing its studies:
durvalumab: first FDA approval 2017 (IMFINZI), first EMA approval 2018. What it is approved for, and how studies give it, is on its page →
Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, durvalumab is the treatment under test here. Read study by study →
94 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 17 · Phase 2 62 · Phase 3 17 · Phase 4 2
First in 2013; this study’s year is marked. 15 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 38 is below the median of 62 across 6,023 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Median enrollment 74 across the 94 interventional studies. Of the 47 that completed or were terminated, 27 (57%) have results posted.
This tab as a report to print or save as PDF → With an account.
33 of 94 have an industry lead sponsor. The 10 most frequent:
Alliance Foundation Trials, LLC. is the lead sponsor of 22 studies on the registry; 3 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
Alliance Foundation Trials, LLC. has 5 studies filed under Carcinoma, Non-Small-Cell Lung — fewer than ten, so there is no comparison to draw.
8 of the studies testing durvalumab in Carcinoma, Non-Small-Cell Lung that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04465968Phase 3National Cancer Center Hospital EastEfficacy and Safety of CRT, Durvalumab and Surgery for SST | 2027-08-31 |
| NCT03965468ETOP IBCSG Partners FoundationImmunotherapy, Chemotherapy, Radiotherapy and Surgery for Synchronous Oligo-metastatic NSCLC | 2026-12 |
| NCT04245514Swiss Cancer InstituteMultimodality Treatment in Stage III Non-small Cell Lung Cancer (NSCLC) | 2026-12-07 |
| NCT06908070Idris BahceChemoradiotherapy With Surgery Followed by Consolidation Durvalumab | 2026-12-17 |
| NCT05206812Yonsei UniversityWindow of Opportunity Trial of Durvalumab (MEDI4736) to Identify Immune Dynamics in Operable Non-small Cell Lung Cancer (NSCLC) (MIRACLE) | 2027-01 |
Add all 8 to your calendar (.ics) → With an account.
Among the 94 studies testing durvalumab in Carcinoma, Non-Small-Cell Lung, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a single arm, phase II trial of combined neoadjuvant platinum doublet chemotherapy plus durvalumab followed by surgery, postoperative radiation and adjuvant durvalumab for 13 cycles for patients with potentially resectable stage IIIA and IIIB (T1-3, N2) NSCLC (per the 8th International Association for the Study of Lung Cancer classification). The primary objective of this study is to increase N2 nodal clearance (N2NC) to 50% or greater for combined platinum doublet chemotherapy with durvalumab induction therapy from historical rate of 30% for platinum doublet chemotherapy alone in patients with potentially resectable stage IIIA/B (N2) NSCLC.
In the preoperative period, patients who have undergone adequate mediastinal evaluation and are considered operable will be treated with durvalumab 1125 mg IV every 3 weeks (Q3W) in combination with platinum doublet chemotherapy (cisplatin with pemetrexed or docetaxel, depending upon histology).
Patients will undergo postoperative radiation (54Gy) within 4-10 weeks after surgery (unless single station N2 at registration with resultant ypT0N0 after neoadjuvant therapy).
One to 6 weeks after completion of radiation, patients will receive adjuvant durvalumab 1500 mg IV every 4weeks (Q4W) for 1 year.
Patients who do not have surgery due to refusal, physician decision, or local and distant progression will have to discontinue study treatment.
All participants will have imaging assessment prior to surgery after Cycle 2 (Week 6) and after Cycle 4 (Weeks 13 15). Patients will undergo potentially curable surgery as per standard of care.
Patients will undergo imaging assessment every 12 weeks after surgery for 2 years, then every 6 months for 3 years.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Operability Criteria:
Inclusion Criteria:
proven N2 disease within 4 weeks of registration. PET/CT positivity in the ipsilateral mediastinal nodes will not be sufficient to establish N2 nodal status. Mediastinal lymph node sampling is required pre-operatively by at least one of the following:
Mediastinal nodal biopsy or aspiration can only be omitted in the special circumstance in which ALL of the following are true:
Organ and marrow function definitions (example below)
Evidence of status or negative urinary or serum pregnancy test for female premenopausal patients. Women will be considered postmenopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
Exclusion Criteria:
Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], active 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:
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.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
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.
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).
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.
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.
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.
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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
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.
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.
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.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Combined neoadjuvant platinum doublet chemotherapy plus durvalumab followed by surgery, postoperative radiation and adjuvant durvalumab for 13 cycles.
Drug: Durvalumab · Procedure: Surgery · Radiation: Radiotherapy
Preoperative Treatment: * Non-squamous NSCLC: durvalumab 1125 mg, followed by pemetrexed 500 mg/m2 IV with cisplatin 75 mg/m2 IV, every 3 weeks, for 4 cycles * Squamous NSCLC: durvalumab 1125 mg, followed by docetaxel 75 mg/m2 IV with cisplatin 75 mg/m2 IV, every 3 weeks, for 4 cycles Adjuvant Therapy: • 1-6 weeks after completion of radiotherapy, durvalumab 1500 mg IV every 4 weeks will be administered for 13 cycles.
Also known as: Imfinzi
Patients will be re-evaluated following preoperative treatment to assess if patient is still medically fit to withstand surgery. Eligible patients will then undergo lobectomy, bilobectomy, sleeve lobectomy or other extended resection, or a pneumonectomy will be performed at the discretion of the attending thoracic surgeon.
4-10 weeks after surgery, patients will receive 54 Gy of radiotherapy with single daily fractions.
N2 Nodal Clearance (N2NC)
The percent of patient to increase N2 nodal clearance (N2NC) to 50% or greater for combined platinum doublet chemotherapy with durvalumab induction from an historical rate of 30% for platinum doublet chemotherapy alone in patients with potentially resectable stage IIIA/B (N2) NSCLC.
Time frame: 3 years 11 months
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
To evaluate the safety and tolerability of neoadjuvant platinum doublet chemotherapy and durvalumab followed by surgery followed by adjuvant radiation and durvalumab.
Time frame: 5 years
Radiographic Response Rate
To assess the radiographic response rate of neoadjuvant platinum doublet chemotherapy and durvalumab.
Time frame: 5 years
Rate of Major Pathologic Response and Pathologic Complete Response
To evaluate the rate of major pathologic response and pathologic complete response in the resected primary tumor and lymph nodes following neoadjuvant combination therapy as evaluated per criteria stated in the study protocol.
Time frame: 16 weeks
Evaluate Event Free Survival (EFS)
EFS evaluated from the time of registration to one of the following events, whichever comes first: a) radiographic disease progression, b) local progression as defined by lymph node progression precluding surgery, c) inability to resect the tumor, d) local or distant recurrence, e) death due to any cause.
Time frame: 5 years
Overall Survival Rate
To evaluate overall survival rate from the time of registration
Time frame: 5 years
Rate of Complete Resection.
To assess the rate of complete resection.
Time frame: 16 weeks
Post-operative Complications
To assess post-operative complications
Time frame: Within 30 days of surgery
| Milestone | Pre Amendment 3 | Post Amendment 3 |
|---|---|---|
| Started | 6 | 32 |
| Completed | 6 | 31 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Milestone | Pre Amendment 3 | Post Amendment 3 |
|---|---|---|
| Started | 6 | 31 |
| Completed | 5 | 25 |
| Not completed | 1 | 6 |
| Withdrew: Death | 0 | 2 |
| Withdrew: Lack of efficacy | 1 | 4 |
| Milestone | Pre Amendment 3 | Post Amendment 3 |
|---|---|---|
| Started | 5 | 25 |
| Completed | 5 | 25 |
| Not completed | 0 | 0 |
The percent of patient to increase N2 nodal clearance (N2NC) to 50% or greater for combined platinum doublet chemotherapy with durvalumab induction from an historical rate of 30% for platinum doublet chemotherapy alone in patients with potentially resectable stage IIIA/B (N2) NSCLC.
| percentage of participants | Treatment |
|---|---|
| N2 Nodal Clearance (N2NC) | 73.3 |
To evaluate the safety and tolerability of neoadjuvant platinum doublet chemotherapy and durvalumab followed by surgery followed by adjuvant radiation and durvalumab.
Results for this outcome have not been posted.
To assess the radiographic response rate of neoadjuvant platinum doublet chemotherapy and durvalumab.
Results for this outcome have not been posted.
To evaluate the rate of major pathologic response and pathologic complete response in the resected primary tumor and lymph nodes following neoadjuvant combination therapy as evaluated per criteria stated in the study protocol.
| percentage of participants | Treatment |
|---|---|
| Major Pathologic Response | 50 |
| Pathologic Complete Response | 30 |
EFS evaluated from the time of registration to one of the following events, whichever comes first: a) radiographic disease progression, b) local progression as defined by lymph node progression precluding surgery, c) inability to resect the tumor, d) local or distant recurrence, e) death due to any cause.
Results for this outcome have not been posted.
To evaluate overall survival rate from the time of registration
Results for this outcome have not been posted.
To assess the rate of complete resection.
| percentage of patients | Treatment |
|---|---|
| Rate of Complete Resection. | 93.3 |
To assess post-operative complications
Results for this outcome have not been posted.
Collected over 5 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pre Amendment 3 | 1/6 (16.7%) | 2/6 (33.3%) | 6/6 (100%) |
| Post Amendment 3 | 9/31 (29%) | 16/31 (51.6%) | 26/31 (83.9%) |
| Event | Pre Amendment 3 | Post Amendment 3 |
|---|---|---|
| Lung infectionInfections and infestations | 1/6 | 1/31 |
| MeningitisInfections and infestations | 1/6 | 0/31 |
| Skin infectionInfections and infestations | 1/6 | 1/31 |
| Alanine aminotransferase increasedInvestigations | 1/6 | 0/31 |
| PresyncopeNervous system disorders | 1/6 | 0/31 |
| SyncopeNervous system disorders | 1/6 | 0/31 |
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 1/6 | 0/31 |
| FallInjury, poisoning and procedural complications | 0/6 | 2/31 |
| HyponatremiaMetabolism and nutrition disorders | 0/6 | 2/31 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 0/6 | 2/31 |
| Event | Pre Amendment 3 | Post Amendment 3 |
|---|---|---|
| NauseaGastrointestinal disorders | 5/6 | 13/31 |
| FatigueGeneral disorders | 5/6 | 22/31 |
| AnemiaBlood and lymphatic system disorders | 4/6 | 19/31 |
| Blood lactate dehydrogenase increasedInvestigations | 4/6 | 9/31 |
| HyperglycemiaMetabolism and nutrition disorders | 4/6 | 8/31 |
| ConstipationGastrointestinal disorders | 3/6 | 12/31 |
| Lymphocyte count decreasedInvestigations | 3/6 | 9/31 |
| Peripheral sensory neuropathyNervous system disorders | 3/6 | 3/31 |
| Neutrophil count decreasedInvestigations | 1/6 | 11/31 |
| White blood cell decreasedInvestigations | 2/6 | 11/31 |
| Age, Continuous(years) | Pre Amendment 3 | Post Amendment 3 | Total |
|---|---|---|---|
| Median | 65.1 (57.9 to 71.3) | 67.3 (39.2 to 81.9) | 67 (39.2 to 81.9) |
| Sex: Female, Male(Participants) | Pre Amendment 3 | Post Amendment 3 | Total |
|---|---|---|---|
| Female | 5 | 12 | 17 |
| Male | 1 | 19 | 20 |
| Ethnicity (NIH/OMB)(Participants) | Pre Amendment 3 | Post Amendment 3 | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 6 | 31 | 37 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Pre Amendment 3 | Post Amendment 3 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 3 |
| White | 4 | 24 | 28 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 4 | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2021 to primary completion in Feb 2025, 47 months.
Results were first posted in Sep 2026, 1 year 6 months after primary completion.
Of 730 non-industry phase 2 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 84. This study's 47 months is below that.
Counting every sponsor, half of 1,047 studies reached it within 48 months; a quarter within 30 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
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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
Carcinoma, Non-Small-Cell Lung →
Alliance Foundation Trials, LLC.