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New drug combo aims to stall rare lung cancer

NCT ID NCT07234058

Disease control Sponsor: Intergroupe Francophone de Cancerologie Thoracique Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times

Summary

This study tests whether adding an experimental immunotherapy (fianlimab) to standard treatment (cemiplimab plus chemotherapy) can better control pleural mesothelioma, a rare and aggressive cancer of the lung lining. About 126 people who have not yet been treated will receive one of two drug combinations. The goal is to see if the disease stays stable or shrinks for at least 6 months. This is not a cure; treatment continues as long as it works or up to 2 years.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

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

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 126 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Sep 2029

An estimate. End dates often move.

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 to 75 years

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: 1. Signed written Informed Consent. * Subjects must have signed and dated an IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care. * Subjects must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing. 2. Histological diagnosis (no cytology allowed, thoracoscopy biopsy recommended). 3. Non resectable PM as evaluated by a specialist MTB comprising a specialized thoracic surgeon. 4. Measurable disease by CT with iodure injection according to RECIST 1.1 modified criteria for mesothelioma (pleural thickness perpendicular to the chest wall or mediastinum of 7 mm or more, on 2 positions, at 3 separate levels on transverse cuts of CT-scan, at least 1 cm apart, the sum of 6 measurements defining a pleural unidimensional measure), or according to RECIST1.1 criteria for mediastinal nodes or metastatic lesion. 5. ECOG PS 0 and 1. 6. Weight loss \<10% within 3 months of study entry. 7. Chemo-naive and immuno-naive. 8. Age ≥18 years, \<76 years. 9. Life expectancy \>3 months. 10. Available pathological samples (at least 10 slides from the thoracoscopy pleural biopsy sample). 11. Adequate biological functions: creatinine clearance ≥45 mL/min (Cockroft or MDRD or CKD-epi); neutrophils ≥1500/mm3; platelets ≥100 000/mm3; haemoglobin ≥9g/dL; AST and ALT \<3 x ULN, total bilirubin \<2 x ULN (patients with hepatic metastases or Gilbert's syndrome must have AST and ALT ≤5 x ULN and a baseline total bilirubin ≤2 x ULN). 12. WOCBP\* must have a negative serum (beta-hCG) at screening. \*WOCBP are defined as women who are fertile following menarche until becoming postmenopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high FSH level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to determine the occurrence of a postmenopausal state. The above definitions are according to the CTFG guidance. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation. 13. Male study participants with WOCBP partners are required to use condoms during the study and until 6 months after the last dose of study treatment unless they are vasectomised or practice sexual abstinence. 14. Vasectomised partner or vasectomised study participant must have received medical assessment of the surgical success. NB: Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and LAM are not acceptable methods of contraception. Female condom and male condom should not be used together. 15. WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the entire trial and until 6 months after last treatment. 16. All men must agree not to donate sperm during the trial and for 6 months after receiving the last therapy dose. 17. As recommended in current French guidelines, a firm recommendation of radiation therapy for thoracocentesis tracts (3 x 7Gy) is made for patients with thoracocentesis or thoracoscopy within 2 months before accrual, with a firmly recommended interval between thoracoscopic procedure (removal of drains) and radiation of no more than 42 days. A 7-day interval between the end of radiotherapy and the initiation of treatment should be respected. Exclusion Criteria: 1. ECOG PS\>2. 2. Previous cancer treatment including chemotherapy or immunotherapy with anti-PD-1, anti-PD-L1, Anti-CTLA4 or any ICI antibody. 3. Pleural effusion as the only radiological abnormality without measurable pleural thickness or mediastinal node enlargement. 4. Peritoneal, pericardial or tunica vaginalis testis mesothelioma. 5. Previous diagnosis of adenocarcinoma from any anatomic site within the previous 5 years, with the exception of prostate adenocarcinoma history within the previous 5 years, in case of localized prostate cancer, with good prognostic factors according to d'Amico classification (\<T2a, score de Gleason ≤6 and PSA ≤10 ng/ml) provided they were treated in a curative way (surgery or radiotherapy, without any chemotherapy). Previous or active cancer within the previous 5 years (except for treated carcinoma in situ of the cervix, or basal cell skin cancer treated or not). 6. Uncontrolled pleural effusion requiring frequent thoracocentesis (needing thoracoscopic pleural pleurodesis before possible accrual). 7. Symptomatic untreated brain metastasis (without previous whole brain radiotherapy or stereotactic ablative brain radiotherapy or without surgical resection). At least 2 weeks delay between the end of radiotherapy and the beginning of immuno-chemotherapy treatment should be respected. Asymptomatic brain metastasis, not needing corticosteroids greater than 10 mg prednisone equivalent daily or mannitol infusions, are allowed. 8. Radiotherapy needed at initiation of tumour treatment, except bone palliative radiotherapy on a painful or compressive metastasis, or radiotherapy on thoracic drain or puncture routes. 9. History of previous primary immunodeficiency, organ transplantation needing an immunosuppressive treatment, any immunosuppressive drug within 28 days before randomisation date, or history of severe toxicity (grade 3/4) by immune mechanism linked to another immunotherapy treatment for any kind of disease. 10. Systemic treatment with corticosteroids with greater dose than 10 mg prednisone equivalent daily, within 14 days before initiation of the treatment. Inhaled, nasal or topic corticosteroids are allowed. 11. History of active autoimmune disease, needing systemic immunosuppressive drug, including but not limited to rheumatoid polyarthritis, myasthenia, autoimmune hepatitis, systemic Lupus, Wegener's granulomatosis, vascular thrombosis associated with anti-phospholipid syndrome, Sjogren's syndrome with interstitial pulmonary disease, recent Guillain-Barré syndrome within previous 15 years, multiple sclerosis, vasculitis, or glomerulonephritis. Patients with type I diabetes, or hypothyroidy, or immune cutaneous disease (vitiligo, psoriasis, alopecia) or benign rheumatoid polyarthritis not needing any immunosuppressive systemic treatment or over 10 mg daily oral steroids, or benign sicca syndrome (Sjogren) without interstitial pulmonary disease, or history of past Guillain-Barré syndrome beyond 15 previous years, totally reversible with no sequalae, no systemic immunosuppressive treatment during the last 20 years, can be included. Patients with Grave's disease or psoriasis not requiring systemic therapy within the last two years from randomisation can be included. 12. Active inflammatory intestinal disease (diverticulosis, Crohn disease, haemorrhagic recto-colitis, coeliac disease) requiring systemic treatment, or any serious chronic intestinal disease with uncontrolled diarrhoea. 13. History or current evidence of significant (CTCAE grade ≥2) local or systemic infection (e.g. cellulitis, pneumonia, septicaemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial medication. 14. Active uncontrolled infection requiring therapy including active tuberculosis. Past primary pulmonary tuberculosis in youth does not consist of a contra-indication. Past tuberculosis disease history does not consist of a contra-indication provided the patient was treated during at least 6 months by anti-tuberculosis antibiotic treatment. 15. Uncontrolled infection with HIV, HBV, or HCV infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection. Notes: 1. Patients with known HIV who have controlled infection (undetectable viral load and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are permitted. For patients with controlled HIV infection, monitoring will be performed per local standards. 2. Patients with known hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA per local standards and must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug. 3. Patients who are known hepatitis C virus antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted. 4. Patients with HIV or hepatitis must be reviewed by a qualified specialist (e.g. infectious disease or hepatologist) managing this disease prior to commencing and regularly throughout the duration of their participation in the trial. 16. Received a live vaccine within 30 days of planned start of study medication. Live or live attenuated vaccination with replicating potential. If a patient intends to receive a COVID-19 vaccine before the start of study drug, participation in the study should be delayed at least 1 week after any COVID-19 vaccination. During the treatment period, it is recommended to delay COVID-19 vaccination until patients are receiving and tolerating a steady dose of study drug. A vaccine dose should not be less than 48 hours before or after study drug dosing. mRNA and adenovirus vector anti-SARS-CoV2 vaccine are allowed. 17. General serious condition such as congestive uncontrolled cardiac failure, uncontrolled cardiac arrythmia, uncontrolled ischemic cardiac disease (unstable angina or history of myocardial infarction within the previous 6 months), history of stroke within the 6 previous months, history of myocarditis. Patients with a significant cardiac history, even if controlled, should have a LVEF \>45%. 18. TnT or troponin I TnI \> 2x institutional ULN at baseline. Patients with TnT or TnI levels between \>1 to 2xULN are permitted if repeat levels within 24 hours are ≤ 1x ULN. If TnT or TnI levels are \>1 to 2xULN within 24 hours, the subject may undergo a cardiac evaluation and be considered for treatment by the investigator based on cardiological medical judgement in the patient's best interest. 19. Known hypersensitivity to the active substances or to any of the excipients. 20. Pre-existing moderate or severe lung interstitial disease as assessed by the diagnosis CT-scan and decrease of TLCO higher than 35% from theoretical normal values linked to such interstitial disease. 21. Inability to comply with study or follow-up procedures as estimated by the referent investigator. 22. Pregnant or breastfeeding women. 23. Women of childbearing potential (WOCBP)\* who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose. Highly effective contraceptive measures include: 1. Stable use of combined (oestrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening; 2. Intrauterine device; intrauterine hormone-releasing system; 3. Bilateral tubal occlusion/ligation; 4. Vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the WOCBP study participant and that the vasectomized partner has obtained medical assessment of surgical success for the procedure); or 5. Sexual abstinence†. \*Pregnancy testing and contraception are required for WOCBP. †Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drugs. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject. 24. For patients receiving cisplatin: patients with hearing problems; creatinine clearance \<60 ml/min; patients concomitantly receiving phenytoin with prophylactic aim.

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Conditions

The condition(s) this trial relates to.

malignant pleural mesothelioma Mesothelioma, Malignant pleural mesothelioma

As listed by the trial registrant

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

Pleural mesotheliomas

How to take part

Only the study team decides who joins. These are the ways to reach them.

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

37 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Show contact details

Locations

Aix-Pertuis - CHI
NOT_YET_RECRUITING

Aix-en-Provence, France

Contact Email: •••••@•••••
Amiens - CHU
NOT_YET_RECRUITING

Amiens, France

Contact Email: •••••@•••••
Angers - CHU
NOT_YET_RECRUITING

Angers, France

Contact Email: •••••@•••••
Avignon - CH
NOT_YET_RECRUITING

Avignon, France

Contact Email: •••••@•••••
Besançon - CHU
NOT_YET_RECRUITING

Besançon, 75009, France

Contact Email: •••••@•••••
Bordeaux - CHU
NOT_YET_RECRUITING

Pessac, France

Contact Email: •••••@•••••
Bordeaux - Institut Bergonié
NOT_YET_RECRUITING

Bordeaux, France

Contact Email: •••••@•••••
Boulogne - APHP Ambroise Paré
RECRUITING

Boulogne-Billancourt, France

Contact Email: •••••@•••••
Caen - CHU
NOT_YET_RECRUITING

Caen, France

Contact Email: •••••@•••••
Clermont-Ferrand - CHU
NOT_YET_RECRUITING

Clermont-Ferrand, France

Contact Email: •••••@•••••
Clermont-Ferrand - Centre Jean Perrin
NOT_YET_RECRUITING

Clermont-Ferrand, France

Contact Email: •••••@•••••
Créteil - CHI
NOT_YET_RECRUITING

Créteil, France

Contact Email: •••••@•••••
Dijon - Centre Georges-François Leclerc
NOT_YET_RECRUITING

Dijon, France

Contact Email: •••••@•••••
Grenoble - CHU
NOT_YET_RECRUITING

Grenoble, France

Contact Email: •••••@•••••
La Roche-Sur-Yon - CHD Vendée
NOT_YET_RECRUITING

La Roche-sur-Yon, France

Contact Email: •••••@•••••
Le Mans - CHG
NOT_YET_RECRUITING

Le Mans, France

Contact Email: •••••@•••••
Lille - CHU
RECRUITING

Lille, France

Contact Email: •••••@•••••
Lyon - HCL
NOT_YET_RECRUITING

Pierre-Bénite, France

Contact Email: •••••@•••••
Marseille - APHM Nord
NOT_YET_RECRUITING

Marseille, France

Contact Email: •••••@•••••
Marseille - Hôpital Européen
NOT_YET_RECRUITING

Marseille, France

Contact Email: •••••@•••••
Montpellier - CHU
NOT_YET_RECRUITING

Montpellier, France

Contact Email: •••••@•••••
Mulhouse - GHRMSA
NOT_YET_RECRUITING

Mulhouse, France

Contact Email: •••••@•••••
Nantes - Hôpital Laennec
RECRUITING

Nantes, France

Contact Email: •••••@•••••
Nantes - Institut de Cancérologie de l'Ouest
NOT_YET_RECRUITING

Saint-Herblain, 75009, France

Contact Email: •••••@•••••
Paris - APHP Bichat
RECRUITING

Paris, France

Contact Email: •••••@•••••
Paris - APHP Cochin
NOT_YET_RECRUITING

Paris, France

Contact Email: •••••@•••••
Reims - Institut Godinot
RECRUITING

Reims, France

Contact Email: •••••@•••••
Rennes - CHU
NOT_YET_RECRUITING

Rennes, France

Contact Email: •••••@•••••
Saint-Nazaire - Clinique Mutualiste de l'Estuaire
NOT_YET_RECRUITING

Saint-Nazaire, France

Contact Email: •••••@•••••
Strasbourg - Nouvel Hôpital Civil
RECRUITING

Strasbourg, 75009, France

Contact Email: •••••@•••••
Toulon - CHI
RECRUITING

Toulon, France

Contact Email: •••••@•••••
Toulon - Sainte Anne HIA
NOT_YET_RECRUITING

Toulon, France

Contact Email: •••••@•••••
Toulouse - CHU
RECRUITING

Toulouse, France

Contact Email: •••••@•••••
Tours - CHU
RECRUITING

Tours, 75009, France

Contact Email: •••••@•••••
Vandoeuvre-lès-Nancy - Institut de Cancérologie de Lorraine
NOT_YET_RECRUITING

Vandœuvre-lès-Nancy, France

Contact Email: •••••@•••••
Villefranche sur Saône - CH
NOT_YET_RECRUITING

Villefranche-sur-Saône, France

Contact Email: •••••@•••••
Villejuif - Gustave Roussy
NOT_YET_RECRUITING

Villejuif, France

Contact Email: •••••@•••••

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