Immunotherapy plus chemo shows promise in tough lung cancer

NCT ID NCT04334759

Disease control Sponsor: PrECOG, LLC. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding the immunotherapy drug durvalumab to standard chemotherapy helps people with advanced pleural mesothelioma live longer. The trial included 214 adults whose cancer could not be removed by surgery. Participants received either the combination or a standard treatment chosen by their doctor. The goal was to see if the new approach improves overall survival.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

214 people

The number who actually took part.

Started

Feb 2021

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults (18 years or over) with a histological diagnosis of epithelioid pleural mesothelioma that is not amenable to curative surgical resection. Histological diagnosis requires tumour tissue from an open biopsy, or a core biopsy with a needle of 19 gauge or wider. * Measurable disease as per modified RECIST 1.1 (mRECIST 1.1) criteria for assessment of response in pleural mesothelioma, without prior radiotherapy to these sites. * Body weight \>30 kg, * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Tumour tissue (Formalin-Fixed Paraffin-Embedded \[FFPE\]) available from standard of care diagnostic biopsy for PD-L1 testing and other correlative biomarker testing at a central laboratory. * Life expectancy of at least 12 weeks. * 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. * Haemoglobin ≥ 9.0 g/L * Absolute neutrophil count ≥ 1.5 x 10\^9/L * Platelets ≥ 100 x 10\^9/L * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (except participants with Gilbert's Syndrome, who are eligible with bilirubin ≤ 2.5 ULN) * Alanine transaminase ≤ 2.5 x upper limit of normal (ULN), unless liver metastases or invasion are present, in which case it must be ≤ 5 x ULN * Aspartate aminotransferase ≤ 2.5 x ULN, unless liver metastases or invasion are present, in which case it must be ≤ 5 x ULN * Creatinine clearance (CrCl) ≥ 45 mL/min (Cockcroft-Gault formula). NOTE: Carboplatin AUC 5 must be the initial platinum agent of choice in patients with creatinine Cl \<60 mL/min but ≥ 45 mL/min, or those with clinically reported hearing loss. * Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient or legal representative must sign a consent form prior to enrolment in the trial to document their willingness to participate. * Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments. * Women of childbearing potential must use a reliable means of contraception during treatment and for at least 90 days thereafter. Breastfeeding is not permissible during or for at least 90 days after the final study treatment. Men must have been surgically sterilised or use a barrier method of contraception if they are sexually active with a woman of child bearing potential. * Evidence of post-menopausal status or negative serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. Exclusion Criteria: * Non-epithelioid histology (biphasic or sarcomatoid). * Prior chemotherapy or other systemic anti-cancer or immunotherapy for PM. * Diagnosis based only on cytology or aspiration biopsy with a needle narrower than 19 gauge. * Active or prior documented autoimmune 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: 1. Patients with vitiligo or alopecia 2. Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement 3. Any chronic skin condition that does not require systemic therapy 4. Patients without active disease in the last 5 years may be included 5. Patients with celiac disease controlled by diet alone * Any condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone or equivalent dose of an alternative corticosteroid) or other immunosuppressive medications within 28 days of durvalumab or ipilimumab or nivolumab administration. Intranasal, inhaled or topical steroids or local steroid injections (e.g. intra-articular injection) are permitted in the absence of active autoimmune disease. Standard steroid premedication given prior to chemotherapy or as prophylaxis for imaging contrast allergy should not be counted for this criterion. * Participants with symptomatic or uncontrolled brain metastases or leptomeningeal disease are excluded. * Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways. * Current treatment or treatment within the last 12 months with any investigational anti-cancer products. * Concurrent enrolment in another clinical study testing an anticancer treatment. * Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 msec in screening ECG measured using standard institutional method or history of familial long QT syndrome. * Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of study treatment on protocol. Note: Local surgery of isolated lesions for palliative intent is acceptable. Limited pleural biopsy procedures do not apply. * No other malignancy that requires active treatment. Participants with a past history of adequately treated carcinoma in situ, non-melanoma skin cancer or lentigo maligna without evidence of disease or superficial transitional cell carcinoma of the bladder are eligible. * Hearing loss or peripheral neuropathy considered by the investigators to contraindicate administration of either cisplatin, carboplatin or pemetrexed. * History of allergy or hypersensitivity to investigational product, cisplatin, carboplatin, pemetrexed, ipilimumab, nivolumab or any excipient. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive cardiac failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, active peptic ulcer disease or gastritis, serious chronic gastrointestinal conditions associated with diarrhoea, active bleeding diatheses. * Hepatitis B, hepatitis C or human immunodeficiency virus (HIV). Exceptions include past or resolved Hepatitis B (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) and patients positive for hepatitis C (HCV) antibody if polymerase chain reaction is negative for HCV RNA. HIV testing is not required in absence of clinical suspicion of HIV. * Known history of primary immunodeficiency, allogeneic organ transplant, pneumonitis or active tuberculosis. * Receipt of live attenuated vaccination within 30 days prior to enrolment or within 30 days of receiving durvalumab, ipilimumab, nivolumab. * Specific comorbidities or conditions or concomitant medications which may interact with the investigational product(s). * Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results. * Serious medical or psychiatric conditions or social situation that might limit compliance with study requirements, substantially increase risk of incurring adverse events or compromise the ability of the patient to give written informed consent.

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Conditions

The condition(s) this trial relates to.

malignant pleural mesothelioma mesothelioma Mesothelioma, Malignant pleural epithelioid mesothelioma pleural mesothelioma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Malignant pleural mesothelioma Mesothelioma Pleural mesothelioma

Contacts and locations

Locations

Abramson Cancer Cener at Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States
Allegheny Cancer Center

Pittsburgh, Pennsylvania, 15224, United States
Auckland City Hospital

Grafton, Auckland, 1023, New Zealand
Austin Hospital

Heidelberg, Victoria, 3084, Australia
Baylor College of Medicine

Houston, Texas, 77030, United States
Blacktown Hospital

Blacktown, New South Wales, 2148, Australia
Calvary Mater Newcastle

Waratah, New South Wales, 2298, Australia
Canberra Hospital

Garran, Australian Capital Territory, 2605, Australia
Chris O'Brien Lifehouse

Camperdown, New South Wales, 2050, Australia
Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States
Coffs Harbour Health Campus

Coffs Harbour, New South Wales, 2450, Australia
Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States
Emory University

Atlanta, Georgia, 30322, United States
Epworth HealthCare - Richmond

Richmond, Victoria, 3121, Australia
Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia
Gosford Hospital

Gosford, New South Wales, 2250, Australia
Goulburn Valley Health

Shepparton, Victoria, 3630, Australia
Icon Cancer Care Chermside

Chermside, Queensland, 4032, Australia
Icon Cancer Care South Brisbane

South Brisbane, Queensland, 4101, Australia
Icon Cancer Care Wesley

Auchenflower, Queensland, 4066, Australia
Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21287, United States
Launceston General Hospital

Launceston, Tasmania, 7250, Australia
Liverpool Hospital

Liverpool, New South Wales, 2170, Australia
MD Anderson Cancer Center

Houston, Texas, 77030, United States
Massaschusetts General Hospital

Boston, Massachusetts, 02114, United States
Memorial Sloan Kettering

New York, New York, 10065, United States
Metro Minnesota Community Oncology Research Consortium

Saint Louis Park, Minnesota, 55416, United States
Moffitt Cancer Center

Tampa, Florida, 18054, United States
Monash Health

Clayton, Victoria, 3168, Australia
Morristown Medical/Atlantic Health

Morristown, New Jersey, 07960, United States
Nepean Hospital

Kingswood, New South Wales, 2747, Australia
NorthShore University Health System/Kellogg Cancer Center

Evanston, Illinois, 60201, United States
Northern Cancer Institute (GenesisCare)

Saint Leonards, New South Wales, 2065, Australia
Orange Health Service

Orange, New South Wales, 2800, Australia
Peninsula & South Eastern Haematology and Oncology Group

Frankston, Victoria, 3199, Australia
Penn State Cancer Institute

Hershey, Pennsylvania, 17033, United States
Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia
Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia
Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia
Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States
Sir Charles Gairdner Hospital (SCGH)

Nedlands, Western Australia, 6009, Australia
Sunshine Coast University Hospital

Birtinya, Queensland, 4575, Australia
Sunshine Hospital (Western Health)

Saint Albans, Victoria, 3021, Australia
The Ohio State University

Columbus, Ohio, 43210, United States
The Prince Charles Hospital

Chermside, Queensland, 4032, Australia
The Queen Elizabeth Hospital

Woodville South, South Australia, 5011, Australia
Townsville University Hospital

Douglas, Queensland, 4814, Australia
University of California San Diego

La Jolla, California, 92093, United States
University of Chicago

Chicago, Illinois, 60637, United States
University of Cincinnati

Cincinnati, Ohio, 45267, United States
University of Miami

Miami, Florida, 33136, United States
University of Michigan

Ann Arbor, Michigan, 48109, United States
University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States
University of Virginia

Charlottesville, Virginia, 22903, United States
Westmead Hospital

Westmead, New South Wales, 2145, Australia
Wyong Hospital

Hamlyn Terrace, New South Wales, 2259, Australia

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