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Active, not recruitingNCT04092283Updated Oct 26, 2026

Testing the Addition of an Antibody to Standard Chemoradiation Followed by the Antibody for One Year to Standard Chemoradiation Followed by One Year of the Antibody in Patients With Unresectable Stage III Non-Small Cell Lung Cancer

A Phase 3 interventional study of Carboplatin and Cisplatin in Recurrent Lung Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8 and Stage IIIA Lung Cancer AJCC v8, sponsored by National Cancer Institute (NCI). Active, not recruiting at 830 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.

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

Updated Oct 26, 20263 sites added3 sites removedGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
660
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This phase III trial studies how well an antibody (durvalumab) with chemotherapy and radiation therapy (chemoradiation) works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery (unresectable). 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. This study is being done to see if adding durvalumab to standard chemoradiation followed by additional durvalumab can extend patients life and/or prevent the tumor from coming back compared to the usual approach of chemoradiation alone followed by durvalumab.

Read the detailed description

PRIMARY OBJECTIVE:

I. To evaluate whether there is an improvement in overall survival with concomitant chemotherapy/radiation therapy/MEDI4736 (durvalumab) followed by one year (12 cycles) of MEDI4736 (durvalumab) as compared to concomitant chemotherapy/radiation followed by one year (12 cycles) of MEDI4736 (durvalumab).

SECONDARY OBJECTIVES:

I. To evaluate the difference in response using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria to assess whether or not MEDI4736 (durvalumab) added to concomitant chemo/radiation results in an improvement in response rates.

II. To evaluate any difference in progression free survival (PFS) with concomitant chemotherapy/radiation therapy/MEDI4736 (durvalumab) followed by one year (12 cycles) of MEDI4736 (durvalumab) as compared to concomitant chemotherapy/radiotherapy followed by one year of MEDI4736 (durvalumab).

III. To evaluate whether the incidence of recurrence and recurrence pattern is affected by giving MEDI4736 (durvalumab) during chemo/radiation.

IV. To evaluate any difference in toxicity when MEDI4736 (durvalumab) is added to concomitant chemo/radiation using the Common Terminology Criteria for Adverse Events (CTCAE).

OUTLINE:

STEP 1 (CONCURRENT THERAPY): Patients are randomized to 1 of 2 arms.

ARM A: Patients receive durvalumab intravenously (IV) over 60 minutes on days 1 and 15 of cycle 1 and day 1 of cycle 2. Patients also receive 1 of 3 treatment regimens per investigator choice: 1) etoposide IV over 60 minutes on days 1-5 and cisplatin IV over 60 minutes on days 1 and 8 every 28 days for 2 cycles; 2) pemetrexed disodium IV over 60 minutes and cisplatin IV over 60-120 minutes on day 1 every 21 days for 2 cycles; or 3) paclitaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1 every 7 days for 6 cycles. Treatment continues in the absence of disease progression or unacceptable toxicity. Beginning on day 1 of chemotherapy, patients receive radiation therapy 5 days a week for 6 weeks.

ARM B: Patients receive 1 of 3 investigator's choice treatment regimens and radiation therapy as in Arm A.

STEP 2 (CONSOLIDATION THERAPY): Within 14 days after the last dose of radiation (from Step 1), all patients then receive durvalumab IV over 60 minutes on day 1. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months if less than 2 years from study entry, every 6 months if 2-5 years from study entry, and then yearly for years 5-10 from study entry.

02

Conditions studied

  • Recurrent Lung Non-Small Cell Carcinoma
  • Stage III Lung Cancer AJCC v8
  • Stage IIIA Lung Cancer AJCC v8
  • Stage IIIB Lung Cancer AJCC v8
  • Stage IIIC Lung Cancer AJCC v8
  • Unresectable Lung Non-Small Cell Carcinoma
03

In context

Carcinoma, Non-Small-Cell Lung

7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.

This study's planned enrollment of 660 is above the median of 62 across 6,019 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.

Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.

Browse National Cancer Institute (NCI) studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

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.

Inclusion criteria

  • STEP 1 INCLUSION ELIGIBILITY CRITERIA - CONCURRENT THERAPY
  • Patient must be >= 18 years old

  • Patient must have one of the following:

    • Newly diagnosed stage IIIA/B/C non-small cell lung cancer (NSCLC) (per the American Joint Committee on Cancer [AJCC] 8th edition) that is unresectable and is and/or cytologically confirmed
    • Nodal recurrence after surgery for early stage NSCLC
  • Patient must have an (ECOG) performance status of 0 or 1
  • Patient must have a body weight > 30 kg
  • Patient must not have unintentional weight loss > 10% within 30 days prior to registration
  • Patient must have a baseline electrocardiography () obtained within 6 weeks prior to registration
  • Patient must have per (RECIST) version (v)1.1. Baseline imaging assessments and measurements used to evaluate all measurable or non-measurable sites of disease must be done within 4 weeks prior to registration
  • (ANC) >= 1500 cells/uL (obtained =\< 7 days prior to registration)
  • White blood cells (WBC) counts >= 2500/uL (obtained =\< 7 days prior to registration)
  • count >= 100,000/uL (obtained =\< 7 days prior to registration)
  • >= 9.0 g/dL (obtained =\< 7 days prior to registration)
  • Total =\< 1.5 x institutional (ULN) with the following exception: patients with known Gilbert disease who have serum bilirubin level =\< 3 x ULN may be enrolled (obtained =\< 7 days prior to registration)
  • (AST) and alanine transaminase (ALT) =\< 3.0 x institutional ULN (obtained =\< 7 days prior to registration)
  • Serum creatinine =\< 1.5 x institutional ULN or >= 45 mL/min on the basis of the Cockcroft-Gault estimation (obtained =\< 7 days prior to registration)
  • Patient must have pulmonary function tests (PFTs) with both (FEV1) and diffusion capacity of the lung for carbon monoxide (DLCO) >= 40% of predicted, obtained within 5 months prior to registration
  • Patient is expected to have lung volume (V)20 of =\< 35%, after radiation oncologist views pre-treatment work up

  • Patients with nodal recurrence after surgery for early-stage NSCLC are eligible if the following criteria are met:

    • No prior chemotherapy or radiation was ever administered for this lung cancer originally or for recurrence prior to entering this protocol
    • Prior curative-intent surgery was at least 90 days prior to the nodal recurrence
    • No prior radiation was administered to the region of study cancer that would cause overlap of treatment fields

  • Patients who are (HIV) positive may participate in the study IF they meet all of the following eligibility requirements:

    • They must be stable on their anti-retroviral regimen, and they must be healthy from an HIV perspective
    • They must have a of greater than 250 cells/mcL, obtained within 6 months prior to registration
    • They must not be receiving prophylactic therapy for an opportunistic infection
  • Patients with a prior or concurrent whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the regimen are eligible for this trial. Patients must not have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration
  • Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used
  • All patients of must have a negative blood test or urine study, with a minimum sensitivity 50 mlU/L or equivalent units of HCG, within 7 days prior to registration to rule out pregnancy. A patient of childbearing potential is anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

  • Patients must not expected to conceive or father children by using accepted and highly effective method(s) of during sexual intercourse for at least one week prior to the start of treatment, during protocol treatment, and continue for 90 days after the last dose of protocol treatment.

    • Highly effective methods of contraception include Etonogestrel-releasing implants (Implanon or Norplant), Intravaginal: Ethinylestradiol/etonogestrel-releasing intravaginal devices: e.g., NuvaRing, injection: Medroxyprogesterone injection: e.g., Depo-Provera, combined pill: Normal and low dose combined oral contraceptive pill, patch: Norelgestromin/ethinylestradiol-releasing transdermal system: e.g., Ortho Evra, Minipillc: Progesterone based oral contraceptive pill using desogestrel: Cerazette is currently the only highly effective progesterone based pill
    • Methods that are considered inadequate include male or female condom with or without spermicide; female cap, diaphragm, or sponge with or without spermicide; non-copper containing intrauterine device; progestogen-only oral hormonal contraceptive pills where inhibition of ovulation is not the primary mode of action [excluding Cerazette/desogestrel which is considered highly effective]; and triphasic combined oral contraceptive pills)
  • STEP 2 INCLUSION ELIGIBILITY CRITERIA - CONSOLIDATION
  • Patients with any > grade 2 non-hematologic or > grade 3 hematologic toxicities must recover to grade 2 (or less) within 45 days after the end of Step 1 concurrent chemo/radiation, with the exception of alopecia and vitiligo

Exclusion criteria

Exclusion Criteria:

  • STEP 1 EXCLUSION ELIGIBILITY CRITERIA - CONCURRENT THERAPY
  • Patient must not have any active, known or suspected disease and neuromuscular paraneoplastic syndromes including, but not limited to myasthenia gravis, Lambert-Eaton myasthenic syndrome, limbic encephalitis, myositis, Guillain-Barré, systemic lupus erythematosus, and systemic sclerosis. Patients with type I diabetes mellitus requiring insulin, 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 an external trigger are eligible
  • Patient must not have a history of active (chronic or acute) or infection. Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for hepatitis C virus ribonucleic acid (HCV RNA)
  • Patient must not have a known active tuberculosis infection
  • Patient must not have any severe infections within 4 weeks prior to registration including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
  • Patient must not have signs or symptoms of severe infection (sepsis) within 2 weeks prior registration
  • Patient must not have been treated with systemic immunostimulatory agents (including but not limited to interferon-a [IFN-a], interleukin [IL]-2) within 6 weeks or five half-lives of the drug (whichever is shorter) prior to registration; or treated with an agent within 4 weeks prior to registration (or within five half-lives of the investigational agent, whichever is longer)
  • Patient must not have a history of severe allergic, anaphylactic, or other reactions to chimeric or humanized antibodies or fusion proteins
  • Patient must not have been treated with systemic medications (equivalent to > 10 mg prednisone per day) or other immunosuppressive medications within 7 days prior to registration. Inhaled or topical and adrenal replacement steroid doses equivalent to > 10 mg prednisone per day are permitted in the absence of active autoimmune disease
  • Patient must not have had a prior bone marrow transplantation or prior solid organ transplantation
  • Patient must not have a history of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan within 4 weeks prior to registration
  • Patient must not have had any prior systemic treatment with an , anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways
  • Patient with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment and severity of cardiac symptoms. Symptoms should be stable over the past 3 months. Specifically, patient must not have coronary artery bypass grafting, myocardial infarction, acute coronary syndrome severe/unstable angina, stroke, , or heart failure hospitalization within 3 months prior to registration
  • Patient must not have an uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events (AEs) or compromise the ability of the patient to give written
  • Patient must not have received a live, attenuated vaccine within 4 weeks prior to registration
  • Patient must not have had past radiation to the current intended treatment site
  • Patient must not donate blood or sperm while on study treatment
  • STEP 2 EXCLUSION ELIGIBILITY CRITERIA - CONSOLIDATION
  • Patient must not receive any non-protocol anti-cancer therapy after the end of Step 1 chemo/radiation or during Step 2 consolidation
  • Patients with suspected cases of >= grade 2 pneumonitis (non-infectious) are not eligible for Step 2 consolidative MEDI4736 (durvalumab) and will proceed onto follow-up instead
  • Patient must not have disease progression on the first post-treatment (Step 1 for concurrent chemo/radiation) chest CT scan, which must be obtained within 14 days after the last dose of radiation therapy. If so, the patient is not eligible for Step 2 consolidative MEDI4736 (durvalumab) and will proceed onto follow-up instead
Terms in these criteria, in plain language(31)

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.

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.

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.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

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.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

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.

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.

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.

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).

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.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

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.

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.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

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.

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.

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.

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).

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.

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.

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.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

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.

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.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

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.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

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
660 participants (estimated)

Study arms

  • Experimental
    Arm A (durvalumab, chemotherapy, durvalumab)

    STEP 1 (CONCURRENT THERAPY): Patients receive durvalumab IV over 60 minutes on days 1 and 15 of cycle 1 and day 1 of cycle 2. Patients also receive 1 of 3 treatment regimens per investigator choice: 1) etoposide IV over 60 minutes on days 1-5 and cisplatin IV over 60 minutes on days 1 and 8 every 28 days for 2 cycles; 2) pemetrexed disodium IV over 60 minutes and cisplatin IV over 60-120 minutes on day 1 every 21 days for 2 cycles; or 3) paclitaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1 every 7 days for 6 cycles. Treatment continues in the absence of disease progression or unacceptable toxicity. Beginning on day 1 of chemotherapy, patients receive radiation therapy 5 days a week for 6 weeks. STEP 2 (CONSOLIDATION THERAPY): Within 14 days after the last dose of radiation (from Step 1), all patients then receive durvalumab IV over 60 minutes on day 1. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.

    Drug: Carboplatin · Drug: Cisplatin · Biological: Durvalumab · Drug: Etoposide · Drug: Paclitaxel · Drug: Pemetrexed Disodium

  • Active comparator
    Arm B (chemotherapy, durvalumab)

    STEP 1 (CONCURRENT THERAPY): Patients receive 1 of 3 investigator's choice treatment regimens and radiation therapy as in Arm A. STEP 2 (CONSOLIDATION THERAPY): Within 14 days after the last dose of radiation (from Step 1), all patients then receive durvalumab IV over 60 minutes on day 1. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.

    Drug: Carboplatin · Drug: Cisplatin · Biological: Durvalumab · Drug: Etoposide · Drug: Paclitaxel · Drug: Pemetrexed Disodium

Interventions

  • DrugCarboplatin

    Given IV

    Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, JM8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo

  • DrugCisplatin

    Given IV

    Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin

  • 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

  • DrugEtoposide

    Given IV

    Also known as: Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar, Vepesid, VP 16, VP 16-213, VP 16213, VP-16, VP-16-213, VP-16213, VP16, VP16213

  • DrugPaclitaxel

    Given IV

    Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

  • DrugPemetrexed Disodium

    Given IV

    Also known as: Alimta, Almita, LY231514, N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic Acid Disodium Salt

06

What researchers measure

Primary outcomes

  1. Overall survival (OS)

    Will be estimated using the Kaplan-Meier method, and Cox proportional hazards models will be used to estimate the treatment hazard ratios. The primary comparison of OS will use a logrank test stratified on the randomization stratification factors with a one-sided type I error rate of 2.5%.

    Time frame: From randomization to death from any cause, assessed up to 10 years

Secondary outcomes

  1. Progression-free survival (PFS)

    Will be estimated using the Kaplan-Meier method, and Cox proportional hazards models will be used to estimate the treatment hazard ratios.

    Time frame: From randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or death from any cause, whichever occurs first, assessed up to 10 years

  2. Best objective response

    Will be evaluated via RECIST1.1 criteria. will be compared using Fisher's exact tests with a one-sided type I error rate of 2.5%.

    Time frame: Up to 10 years

  3. Incidence of adverse events

    Toxicity will be determined using the Common Terminology Criteria for Adverse Events (CTCAE) criteria. will be compared using Fisher's exact tests with a one-sided type I error rate of 2.5%

    Time frame: Up to 10 years

  4. Local progression

    Will be defined as any progression confined to the ipsilateral lung or the N1-N3 nodal areas.

    Time frame: Up to 10 years

07

Study locations

830 sites

Showing the first 100 of 830 sites across 2 countries. Choose a country and city above to see the rest.

08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

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

Timeline

3 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2020 (actual). Primary completion is estimated for Dec 2028, 104 months after the start.

Of 109 non-industry phase 3 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 49 and three quarters within 129. This study's planned 104 months is above that.

Counting every sponsor, half of 423 studies reached it within 45 months; a quarter within 30 and three quarters within 69.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 16, 2019
First posted
Sep 17, 2019
StartActual
Apr 29, 2020
Primary completionEst.
Dec 31, 2028
CompletionEst.
Dec 31, 2028
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
3 sites added, 3 sites removed
Show 3 added (3 United States)
  • Vandalia Health/CAMC Institute for Academic Medicine · Charleston, United States
  • Saint Anne Hospital · Burien, United States
  • Trinity Health IHA Medical Group-Alice Gustafson Center · Pontiac, United States
Show 3 removed
  • West Virginia University Charleston Division · Charleston, United States
  • Highline Medical Center-Main Campus · Burien, United States
  • Newland Medical Associates-Pontiac · Pontiac, United States
across 3 updates, Oct 1, 2026 – Oct 26, 2026
Show all 3 updates
  1. Oct 26, 2026
    1 site added, 1 site removed
    Show site
    • Trinity Health IHA Medical Group-Alice Gustafson Center · Pontiac, United States
    Show 1 removed
    • Newland Medical Associates-Pontiac · Pontiac, United States
  2. Oct 22, 2026
    1 site added, 1 site removed
    Show site
    • Saint Anne Hospital · Burien, United States
    Show 1 removed
    • Highline Medical Center-Main Campus · Burien, United States
  3. Oct 1, 2026
    1 site added, 1 site removed
    Show site
    • Vandalia Health/CAMC Institute for Academic Medicine · Charleston, United States
    Show 1 removed
    • West Virginia University Charleston Division · Charleston, United States

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
NCT04092283
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Sep 17, 2019
Start date
Apr 29, 2020
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Oct 26, 2026

Study contacts

Nathan A Pennell
principal investigator · ECOG-ACRIN Cancer Research Group

Oversight

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

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Durvalumab

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