A Phase 3 interventional study of Durvalumab and Standard Chemotherapy in Mesothelioma, Pleural Mesothelioma and Malignant Pleural Mesothelioma, sponsored by PrECOG, LLC.. Completed at 57 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by PrECOG, LLC. · Phase 3, Interventional, and Treatment
Patients with pleural mesothelioma (PM) that cannot be surgically removed will receive standard chemotherapy (cisplatin or carboplatin and pemetrexed) given with durvalumab, a type of immunotherapy, or a treatment chosen by the study doctor, which is either standard chemotherapy or immunotherapy combination (ipilimumab and nivolumab).
Durvalumab is an antibody (a type of human protein) that works by blocking a body substance called Programmed Death-Ligand 1 (PD-L1). Blocking PD-L1 helps the body's immune system attack cancer cells. Research has shown that durvalumab can slow tumor growth and shrink tumors in some people with cancer. Previous studies of combining durvalumab and chemotherapy showed that this combination is active in advanced mesothelioma.
The purpose of this study is to see whether adding durvalumab to standard chemotherapy will improve overall survival (OS) in patients with PM.
Mesothelioma is a malignant tumor of the mesothelial surfaces primarily arising in the thoracic pleura. In the United Kingdom and USA the expected number of cases in the next few decades are 65,000 and 85,000, respectively. Once diagnosed, this disease is rarely cured with a median survival of less than a year.
This is an International, Open-Label, Multi-center, Phase III study. Patients will be randomized 1:1 to receive (a) chemotherapy given with durvalumab versus (b) physician's choice of either chemotherapy alone, or ipilimumab and nivolumab.
Experimental Arm:
- Durvalumab every 3 weeks + standard chemotherapy (cisplatin or carboplatin every 3 weeks + pemetrexed every 3 weeks) for 4 to 6 cycles, followed by durvalumab every 4 weeks until disease progression, unacceptable toxicity or patient withdrawal.
Control Arm: Physician Choice
Tumor assessments and Quality of Life (QOL) forms will be performed at baseline, then at weeks 6, 12, 18, 26, 34, 42, 50 and then every 12 weeks until disease progression. The QOL forms will also be repeated during the first visit after progression.
Mandatory pre-treatment tumor tissue sample (i.e., obtained during a previous procedure or biopsy) for research will also be required. Blood samples for research at 3 time points will be done.
The study is being led jointly by PrECOG as the US sponsor and University of Sydney as the international sponsor.
339 studies on the registry are indexed under Mesothelioma, Malignant; 64 are open to participants now.
This study's enrollment of 214 is above the median of 39 across 271 interventional studies indexed under Mesothelioma, Malignant.
Browse Mesothelioma, Malignant studies →PrECOG, LLC. is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 11 (100%) have results posted.
Compared within Mesothelioma, Malignant, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Mesothelioma. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Adequate blood tests (done within 14 days prior to randomisation) and with values within the ranges specified below. Blood transfusions are permissible if completed at least 7 days prior to treatment start.
Exclusion Criteria:
Active or prior documented or inflammatory disorders (including inflammatory bowel disease [e.g. colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion:
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 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 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.
Versions of RECIST adapted to particular cases. iRECIST is for immunotherapy, where a tumour can look bigger for a while before it shrinks, so growth has to be confirmed on a later scan. mRECIST usually means the version for liver cancer (hepatocellular carcinoma), which measures only the part of a tumour that still has a blood supply.
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.
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.
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 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).
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.
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.
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
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.
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.
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.
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.
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.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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 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.
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.
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.
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.
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.
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.
iRECIST and mRECIST
Versions of RECIST adapted to particular cases. iRECIST is for immunotherapy, where a tumour can look bigger for a while before it shrinks, so growth has to be confirmed on a later scan. mRECIST usually means the version for liver cancer (hepatocellular carcinoma), which measures only the part of a tumour that still has a blood supply.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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.
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.
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.
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.
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.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Durvalumab + Standard Chemotherapy for 4 to 6 cycles, followed by Maintenance with Durvalumab
Drug: Durvalumab
Standard Chemotherapy for 4 to 6 cycles, followed by Observation
Drug: Standard Chemotherapy
Ipilimumab every 6 weeks and Nivolumab every 2 or 3 weeks for up to 2 years.
Drug: Ipilimumab and Nivolumab
Durvalumab 1500 milligrams (mg) intravenous (IV) every 3 weeks + Cisplatin 75 mg/m² or Carboplatin AUC 5 IV every 3 weeks + Pemetrexed 500 mg/m² IV every 3 weeks for 4 to 6 cycles, followed by maintenance with Durvalumab 1500 mg IV every 4 weeks
Also known as: MEDI4736, Imfinzi
Cisplatin 75 mg/m² or Carboplatin AUC 5 IV every 3 weeks + Pemetrexed 500 mg/m² IV every 3 weeks) for 4 to 6 cycles, followed by Observation
Also known as: Cisplatin or Carboplatin and Pemetrexed
Ipilimumab 1 mg/kg every 6 weeks and Nivolumab 360 mg every 3 weeks or 3 mg/kg every 2 weeks for up to 2 years
Also known as: Yervoy, Opdivo
This study also gives Nivolumab, Ipilimumab. No intervention listed here names it: that was found by reading the record.
Median Overall Survival (OS)
OS based on the Kaplan-Meier method is defined as the duration from randomisation to the date of death due to any cause, or is censored at date last known alive.
Time frame: Minimum follow-up is 24 months after randomisation. Median follow-up for survival is of 33 months with range (3 months - 47 months).
Median Progression-Free Survival (PFS)
PFS based on the Kaplan-Meier method is defined as the duration between randomization and documented disease progression (PD) defined per modified RECIST 1.1 for PM and iRECIST, or death, or is censored at time of last disease assessment.
Time frame: Disease was evaluated at baseline, at weeks 6, 12, 18, 26, 34, 42, 50 and then every 12 weeks until disease progression (minimum follow-up is 24 months after randomisation). Median follow-up for survival is of 33 months with range (3 months - 47 months).
Objective Tumour Response Rate (OTRR)
Objective tumour response rate (OTRR) is defined as the proportion of participants with a documented complete response, partial response (CR + PR) based on iRECIST criteria.
Time frame: Disease was evaluated at baseline, then at weeks 6, 12, 18, 26, 34, 42, 50 and then every 12 weeks until disease progression (minimum follow-up is 24 months after randomisation). The treatment duration ranged from 0 to 36 months.
Grade 3-5 Worst Degree Toxicity Rate
Adverse events (AEs) were graded per CTCAEv5 and the worst grade experienced per participant was recorded. The Grade 3-5 toxicity rate is defined as the proportion of treated participants whose worst grade AE was Grade 3, 4, or 5 at any point during the observation period, regardless of treatment attribution.
Time frame: AEs were recorded from randomisation until 30 days after last chemotherapy dose or 90 days after last durvalumab, ipilimumab, or nivolumab dose, whichever was longer. The treatment duration ranged from 0 to 36 months.
Health-Related Quality of Life (QOL): LC29
EORTC Quality of Life Lung Cancer Module (QLQ-LC29), Importance of QOL issues assessed using a four-point scale (1 = not at all, 4 = very much) and transformed to a 0-100 score, where higher scores mean worse possible symptom burden or severe impact.
Time frame: Performed at baseline, then at weeks 6, 12, 18, 26, 34, 42, 50.
Health-Related QOL: EQ-5D-5L
Euro-Quality of Life (EuroQoL) 5 dimension 5 level (EQ-5D-5L) questionnaire, comprising of 5 questions with a score from 1 (no problem) to 5 (extreme problem) and a visual analog scale from 0 (worst) to 100 (best).
Time frame: Performed at baseline, then at weeks 6, 12, 18, 26, 34, 42, 50.
| Milestone | Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | Control Arm for Chemo Cohort: Chemotherapy, Then Observation | Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | Control Arm for IO Cohort: Ipilimumab and Nivolumab |
|---|---|---|---|---|
| Started | 114 | 60 | 17 | 23 |
| Completed | 0 | 38 | 0 | 0 |
| Not completed | 114 | 22 | 17 | 23 |
| Withdrew: Adverse event | 6 | 6 | 0 | 6 |
| Withdrew: Death | 1 | 5 | 1 | 0 |
| Withdrew: Physician decision | 8 | 3 | 2 | 1 |
| Withdrew: Withdrawal by subject | 3 | 2 | 1 | 1 |
| Withdrew: Disease progression | 87 | 1 | 11 | 13 |
| Withdrew: Not treated | 2 | 5 | 0 | 0 |
| Withdrew: Patient moved to off label supply of durvalumab following declaration of study closure by sponsor | 5 | 0 | 1 | 0 |
| Withdrew: Functional decline due to medical comorbidities | 1 | 0 | 0 | 0 |
| Withdrew: Required use of prohibited concomitant treatment | 1 | 0 | 0 | 0 |
| Withdrew: The patient is not dead. | 0 | 0 | 1 | 0 |
| Withdrew: Patient continuing with nivolumab treatment beyond declaration of study closure by sponsor | 0 | 0 | 0 | 2 |
OS based on the Kaplan-Meier method is defined as the duration from randomisation to the date of death due to any cause, or is censored at date last known alive.
| Months | Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | Control Arm for Chemo Cohort: Chemotherapy, Then Observation | Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | Control Arm for IO Cohort: Ipilimumab and Nivolumab |
|---|---|---|---|---|
| Median Overall Survival (OS) | 21 (18 to 27) | 18 (14 to 30) | 21 (9.2 to NA) | NA (NA to NA) |
PFS based on the Kaplan-Meier method is defined as the duration between randomization and documented disease progression (PD) defined per modified RECIST 1.1 for PM and iRECIST, or death, or is censored at time of last disease assessment.
| Months | Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | Control Arm for Chemo Cohort: Chemotherapy, Then Observation | Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | Control Arm for IO Cohort: Ipilimumab and Nivolumab |
|---|---|---|---|---|
| Median Progression-Free Survival (PFS) | 8.0 (7.8 to 9.8) | 7 (5.9 to 8) | 7.8 (6.5 to 11) | 7.7 (6.1 to NA) |
Objective tumour response rate (OTRR) is defined as the proportion of participants with a documented complete response, partial response (CR + PR) based on iRECIST criteria.
| proportion of participants | Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | Control Arm for Chemo Cohort: Chemotherapy, Then Observation | Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | Control Arm for IO Cohort: Ipilimumab and Nivolumab |
|---|---|---|---|---|
| Objective Tumour Response Rate (OTRR) | 0.566 (0.470 to 0.660) | 0.350 (0.231 to 0.484) | 0.529 (0.278 to 0.770) | 0.435 (0.232 to 0.655) |
Adverse events (AEs) were graded per CTCAEv5 and the worst grade experienced per participant was recorded. The Grade 3-5 toxicity rate is defined as the proportion of treated participants whose worst grade AE was Grade 3, 4, or 5 at any point during the observation period, regardless of treatment attribution.
| proportion of participants | Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | Control Arm for Chemo Cohort: Chemotherapy, Then Observation | Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | Control Arm for IO Cohort: Ipilimumab and Nivolumab |
|---|---|---|---|---|
| Grade 3-5 Worst Degree Toxicity Rate | 0.563 | 0.473 | 0.706 | 0.739 |
EORTC Quality of Life Lung Cancer Module (QLQ-LC29), Importance of QOL issues assessed using a four-point scale (1 = not at all, 4 = very much) and transformed to a 0-100 score, where higher scores mean worse possible symptom burden or severe impact.
| score on a scale | Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | Control Arm for Chemo Cohort: Chemotherapy, Then Observation | Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | Control Arm for IO Cohort: Ipilimumab and Nivolumab |
|---|---|---|---|---|
| At baseline | 67.9 ± 19.6 | 67.8 ± 19.6 | 66.9 ± 26.6 | 59.3 ± 18.1 |
| At week 6 | 64.2 ± 19.5 | 63.4 ± 23.4 | 63.3 ± 22.4 | 61.8 ± 18.9 |
| At week 12 | 64.6 ± 19.6 | 61.3 ± 22.8 | 56.4 ± 23.1 | 67.7 ± 14.2 |
| At week 18 | 61.8 ± 20.7 | 61.5 ± 21.6 | 70.4 ± 21.9 | 68.1 ± 14.6 |
| At week 26 | 65.1 ± 22.5 | 69 ± 21.3 | 76.9 ± 21.7 | 66.1 ± 18.9 |
| At week 34 | 72.6 ± 17.3 | 66.7 ± 22.4 | 72.4 ± 16.5 | 70.5 ± 13 |
| At week 42 | 67.3 ± 19.7 | 65 ± 23.2 | 77.8 ± 19.5 | 65.3 ± 17.1 |
| At week 50 | 72 ± 15.4 | 70.8 ± 18.6 | 72.2 ± 19.5 | 65.5 ± 17.1 |
Euro-Quality of Life (EuroQoL) 5 dimension 5 level (EQ-5D-5L) questionnaire, comprising of 5 questions with a score from 1 (no problem) to 5 (extreme problem) and a visual analog scale from 0 (worst) to 100 (best).
| score on a scale | Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | Control Arm for Chemo Cohort: Chemotherapy, Then Observation | Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | Control Arm for IO Cohort: Ipilimumab and Nivolumab |
|---|---|---|---|---|
| At baseline | 80.7 ± 12.7 | 72.5 ± 21.6 | 73.6 ± 15.5 | 71.4 ± 15.6 |
| At week 6 | 75.6 ± 16.6 | 76.3 ± 16.9 | 73.6 ± 17.5 | 74.7 ± 11.9 |
| At week 12 | 75.8 ± 14.8 | 77.4 ± 17 | 80 ± 12.2 | 72.4 ± 15.5 |
| At week 18 | 75.2 ± 16 | 73 ± 15.5 | 77.9 ± 13.5 | 77.1 ± 11.7 |
| At week 26 | 76 ± 18.2 | 73.4 ± 16.7 | 84 ± 16.4 | 73 ± 15.3 |
| At week 34 | 78.7 ± 14.6 | 68.9 ± 19.7 | 81.5 ± 15.6 | 73.8 ± 12.9 |
| At week 42 | 80.1 ± 11.3 | 69 ± 21.8 | 77.3 ± 15.5 | 75.7 ± 15.3 |
| At week 50 | 78 ± 10.6 | 77.4 ± 15.3 | 78.8 ± 21 | 71.3 ± 13.5 |
Collected over AEs will be recorded from randomisation until 30 days after the last dose of chemotherapy or until 90 days after the last dose of durvalumab, ipilimumab or nivolumab, whichever is longer. The median of the observation period for all-cause mortality is 33.9 months with range (3.1 months - 44.6 months).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 81/112 (72.3%) | 50/112 (44.6%) | 111/112 (99.1%) |
| Control Arm for Chemo Cohort: Chemotherapy, Then Observation | 41/55 (74.5%) | 20/55 (36.4%) | 52/55 (94.5%) |
| Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | 8/17 (47.1%) | 8/17 (47.1%) | 17/17 (100%) |
| Control Arm for IO Cohort: Ipilimumab and Nivolumab | 5/23 (21.7%) | 13/23 (56.5%) | 23/23 (100%) |
| Event | Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | Control Arm for Chemo Cohort: Chemotherapy, Then Observation | Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | Control Arm for IO Cohort: Ipilimumab and Nivolumab |
|---|---|---|---|---|
| Lung infectionInfections and infestations | 5/112 | 1/55 | 3/17 | 2/23 |
| Febrile neutropeniaBlood and lymphatic system disorders | 2/112 | 0/55 | 2/17 | 0/23 |
| PainGeneral disorders | 1/112 | 1/55 | 2/17 | 1/23 |
| FeverGeneral disorders | 8/112 | 1/55 | 0/17 | 1/23 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 7/112 | 1/55 | 1/17 | 0/23 |
| AnemiaBlood and lymphatic system disorders | 2/112 | 0/55 | 1/17 | 1/23 |
| Paroxysmal atrial tachycardiaCardiac disorders | 0/112 | 0/55 | 1/17 | 0/23 |
| Small intestinal obstructionGastrointestinal disorders | 1/112 | 1/55 | 1/17 | 1/23 |
| COVID-19Infections and infestations | 1/112 | 0/55 | 1/17 | 1/23 |
| SepsisInfections and infestations | 1/112 | 2/55 | 1/17 | 1/23 |
| Event | Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | Control Arm for Chemo Cohort: Chemotherapy, Then Observation | Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | Control Arm for IO Cohort: Ipilimumab and Nivolumab |
|---|---|---|---|---|
| FatigueGeneral disorders | 71/112 | 25/55 | 10/17 | 11/23 |
| ConstipationGastrointestinal disorders | 66/112 | 26/55 | 8/17 | 5/23 |
| NauseaGastrointestinal disorders | 63/112 | 29/55 | 8/17 | 4/23 |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 34/112 | 12/55 | 1/17 | 11/23 |
| AnemiaBlood and lymphatic system disorders | 43/112 | 13/55 | 8/17 | 1/23 |
| Neutrophil count decreasedInvestigations | 31/112 | 6/55 | 7/17 | 1/23 |
| AnorexiaMetabolism and nutrition disorders | 24/112 | 9/55 | 7/17 | 4/23 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 34/112 | 6/55 | 6/17 | 6/23 |
| DiarrheaGastrointestinal disorders | 33/112 | 7/55 | 5/17 | 7/23 |
| HypophosphatemiaMetabolism and nutrition disorders | 5/112 | 0/55 | 5/17 | 1/23 |
One patient in the experimental arm of the Chemo Cohort was excluded due to a randomization error, with no treatment or follow-up data available.
| Age, Customized(Participants) | Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | Control Arm: Chemotherapy, Then Observation | Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | Control Arm: Ipilimumab and Nivolumab | Total |
|---|---|---|---|---|---|
| 18-70 | 41 | 22 | 10 | 13 | 86 |
| Above 70 | 72 | 38 | 7 | 10 | 127 |
| Sex: Female, Male(Participants) | Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | Control Arm: Chemotherapy, Then Observation | Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | Control Arm: Ipilimumab and Nivolumab | Total |
|---|---|---|---|---|---|
| Female | 17 | 11 | 6 | 10 | 44 |
| Male | 96 | 49 | 11 | 13 | 169 |
| Race (NIH/OMB)(Participants) | Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | Control Arm: Chemotherapy, Then Observation | Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | Control Arm: Ipilimumab and Nivolumab | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 |
| White | 100 | 55 | 12 | 19 | 186 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 13 | 5 | 5 | 4 | 27 |
| Ethnicity (NIH/OMB)(Participants) | Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | Control Arm: Chemotherapy, Then Observation | Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | Control Arm: Ipilimumab and Nivolumab | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 2 | 2 | 1 | 0 | 5 |
| Not Hispanic or Latino | 109 | 57 | 15 | 22 | 203 |
| Unknown or Not Reported | 2 | 1 | 1 | 1 | 5 |
| Region of Enrollment(Participants) | Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | Control Arm: Chemotherapy, Then Observation | Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance | Control Arm: Ipilimumab and Nivolumab | Total |
|---|---|---|---|---|---|
| Australia | 75 | 43 | 7 | 21 | 146 |
| United States | 38 | 17 | 10 | 2 | 67 |
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Studies of the drug tested here: Durvalumab
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