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New hope for lung cancer patients with lung scarring: trial tests safer treatments

NCT ID NCT07420439

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Summary

This study is for people with advanced non-small cell lung cancer who also have interstitial lung disease (ILD), a condition that causes lung scarring. Many doctors avoid treating these patients due to risks of worsening ILD. The trial will test a specific chemotherapy as first treatment and an immunotherapy drug as second treatment to see if they are safe and effective. About 108 participants will be enrolled to gather much-needed data for this group.

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 108 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Nov 2028

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 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 for both parts: * Informed, written and signed consent: Patients must have signed and dated the written informed consent form approved by the ethics committee in accordance with the legal and institutional framework. It must have been signed before protocol-related procedures that are not part of normal patient management are performed. Patients should be willing and able to adhere to the schedule of visits, treatment and laboratory tests. * Patients with radiological ILDs. All cases should be presented in a multidisciplinary board dedicated to ILD to confirm eligibility. In centres without a local multidisciplinary board dedicated to ILD, the national multidisciplinary board CAPID can be used. * NSCLC proven histologically. Cytological evidence is allowed if a cytoblock has been prepared. * Age ≥ 18 years old. * Performance status ≤ 2. * Stage IIIB or IIIC non-eligible to radiation therapy or IV (8th TNM classification, UICC 2015). For other less advanced stages but rejected for any local treatment, possible inclusion discussion with the sponsor. * Disease measurable according to RECIST criteria 1.1 per investigator assessment. * Adequate biological function: Creatinine clearance ≥ 45 mL/min (Cockroft or MDRD or CKD-epi); neutrophils ≥ 1500/mm3; platelets ≥ 100,000/mm3; Haemoglobin ≥ 9 g/dL; liver enzymes\< 3x ULN except for patients with liver metastases (\< 5x ULN); total bilirubin ≤ 1.5x ULN except for patients with proven Gilbert's syndrome (≤ 5x ULN) or patients with liver metastases (≤ 3.0 mg/dL). * Life expectancy of at least 12 weeks. * For female patients of childbearing potential and patients with a partner of childbearing potential, agreement (by the patient and/or partner) to use one or more highly effective contraceptives (failure rate \< 1% per year when used correctly and regularly) and to continue using it for 7 months after the last dose of treatment. Men should not donate their sperm for the duration of the study and for at least 7 months after the last dose of treatment. Oral contraception should always be combined with another method of contraception because of potential interactions with treatment. Patients should always use a condom. * Patient covered by national health insurance. * Protected adults may participate in the study if they can make decisions regarding their medical treatment in accordance with the guardianship judgment. Inclusion Criteria for first-line part: * Patient must be treatment naive for advanced or metastatic disease. Treatment for non-metastatic stage is not considered as a line if there is a time interval of at least 6 months between the last dose of treatment for non-metastatic stage and recurrent disease. * ILD criteria: any type of ILD and any level of severity are allowed Inclusion criteria specific to second-line part * Patients must have received one but no more than one platinum-based therapy for advanced or metastatic disease. Treatment for non-metastatic stage is not considered as a line if there is a time interval of at least 6 months between the last dose of treatment for non-metastatic stage and recurrent disease. * ILD severity criteria: Patients with ILDs with mild to moderate alteration of pulmonary function, defined by Forced Vital Capacity (FVC) ≥ 50% of the predicted value AND DLCO≥ 35% of the of the predicted value. All cases should be presented in a multidisciplinary board dedicated to ILD to confirm eligibility. In centers without a local multidisciplinary board dedicated to ILD, the national multidisciplinary board CAPID can be used. * ILD type criteria: Patient with idiopathic interstitial pneumonia (including IPF and NSIP) or secondary ILDs (including hypersensitivity pneumonia, pneumoconiosis, radiation pneumonitis) could be included. Will be excluded patients with ILDs secondary to connective tissue disease, vasculitis or granulomatosis (including but not limited to granulomatosis with polyangiitis, rheumatoid arthritis, Sjogren's syndrome, scleroderma, myositis/dermatomyositis, anti-synthetase syndrome). For sarcoidosis and for Interstitial pneumonia with autoimmune features (IPAF) inclusion could be confirmed based on a case-by-case discussion with the sponsor. * Available results for Immunoassay including antinuclear antibodies tested by immunofluorescence, rheumatoid factor, anti-CCP, Anti-dsDNA, Anti-Ro (SS-A), Anti-La (SS-B), Anti-ribonucleoprotein, Anti-Smith, Anti-topoisomerase (Scl-70), Anti-tRNA synthetase (Jo-1, PL-7, PL-12, Anti-PM-Scl, Anti-MDA-5), ANCA. Exclusion criteria for both parts * Small cell lung cancer or tumor with mixed histology including a small cell component. * Known EGFR activating mutation or ALK or ROS rearrangements. Inclusion of patients with any other oncogene addiction (excluding KRAS mutations) should be discussed with the sponsor on a case-by-case level. * History of cancer or cancer active within 3 years except those with a negligible risk of metastasis or death treated curatively (such as adequately treated cervical cancer in situ, basal or squamous cell skin cancer or ductal carcinoma in situ curatively treated. For other types of cancer, please contact the IFCT). Patients with a history of prostate cancer in the last 5 years may be included in cases of localized prostate cancer of good prognosis according to the Amico classification (≤ T2a and Gleason score ≤ 6 and PSA ≤ 10 ng/mL) and if they have been treated curatively (surgery or radiotherapy ± hormone therapy, without chemotherapy). * Acute exacerbation of interstitial lung disease less than 6 months ago. Exclusion criteria specific to first line part * Previous systemic therapy (including but not limited to chemotherapy, targeted therapy, immunotherapy). Treatment for non-metastatic stage is not considered as a line if there is a time interval of at least 6 months between the last dose of treatment for non-metastatic stage and recurrent disease. Exclusion criteria specific to second line part * History of severe allergy, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the pembrolizumab/nivolumab formulation. * Diagnosis of interstitial lung disease with manifestations of autoimmunity (IPAF) according to ATS/ERS criteria39 Inclusion may be considered on a case-by-case basis following discussion with the sponsor. * More than one line of treatment. * Any prior immunotherapy. * History of autoimmune disease, connective tissue disease, vasculitis or granulomatosis associated with but not limited to myasthenia gravis, myositis, autoimmune hepatitis, inflammatory bowel disease, vascular thrombosis associated with anti-phospholipid syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis or glomerulonephritis. * Diagnosis of ILDs due to connective tissue disease, vasculitis or granulomatosis including but not limited to granulomatosis with polyangiitis, rheumatoid arthritis, Sjogren's syndrome, scleroderma, myositis/dermatomyositis, anti-synthetase syndrome. For sarcoidosis and for Interstitial pneumonia with autoimmune features (IPAF) inclusion could be confirmed based on a case-by-case discussion with the sponsor. * Corticosteroid therapy \> 10 mg daily oral prednisone or equivalent. * Immunosuppressive therapy within two weeks prior to randomization. * Patients who have had major surgery ≤ 3 weeks before randomization.

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Conditions

The condition(s) this trial relates to.

interstitial lung disease non-small cell lung carcinoma

As listed by the trial registrant

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

Interstitial lung disease (ILD) Non small cell lung cancer metastatic

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    31 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Locations

  • Angers - CHU

    Angers, France

    Contact Email: •••••@•••••

  • Annecy - CH

    Pringy, France

    Contact Email: •••••@•••••

  • Besançon - CHU

    Besançon, France

    Contact Email: •••••@•••••

  • Bobigny - APHP - Hôpital Avicenne

    Bobigny, France

    Contact Email: •••••@•••••

  • Bordeaux - CHU

    Pessac, France

    Contact Email: •••••@•••••

  • Boulogne - APHP Ambroise Paré

    Boulogne-Billancourt, France

    Contact Email: •••••@•••••

  • Boulogne-Sur-Mer - CH

    Boulogne-sur-Mer, France

    Contact Email: •••••@•••••

  • Brest - CHU

    Brest, France

  • Caen - CHU Côte de Nacre

    Caen, 14000, France

  • Clermont-Ferrand - CHU

    Clermont-Ferrand, France

    Contact Email: •••••@•••••

  • Colmar - CH

    Colmar, 68000, France

  • Créteil - CHI

    Créteil, France

    Contact Email: •••••@•••••

  • Dijon - CHU Bocage

    Dijon, France

    Contact Email: •••••@•••••

  • Grenoble - CHU

    Grenoble, 38000, France

  • Lille - CHU

    Lille, France

    Contact Email: •••••@•••••

  • Lyon - HCL

    Lyon, France

    Contact Email: •••••@•••••

  • Marseille - AP-HM Hôpital Nord

    Marseille, France

    Contact Email: •••••@•••••

  • Marseille - Institut Paoli Calmette

    Marseille, France

    Contact Email: •••••@•••••

  • Metz - Hôpital Robert Schuman

    Metz, France

    Contact Email: •••••@•••••

  • Montpellier - CHU

    Montpellier, France

    Contact Email: •••••@•••••

  • Nantes - CHU Hôpital Laënnec

    Nantes, France

    Contact Email: •••••@•••••

  • Paris - APHP - Tenon

    Paris, 75020, France

    Contact Email: •••••@•••••

  • Paris - APHP Bichat

    Paris, France

    Contact Email: •••••@•••••

  • Paris - APHP Cochin

    Paris, France

    Contact Email: •••••@•••••

  • Paris - APHP Pitié-salpêtrière

    Paris, France

    Contact Email: •••••@•••••

  • Paris - Saint Joseph

    Paris, France

    Contact Email: •••••@•••••

  • Rennes - CHU

    Rennes, France

    Contact Email: •••••@•••••

  • Strasbourg - NHC

    Strasbourg, 63000, France

    Contact Email: •••••@•••••

  • Suresnes - Foch

    Suresnes, France

    Contact Email: •••••@•••••

  • Tours - CHU

    Tours, France

    Contact Email: •••••@•••••

  • Villefranche-Sur-Saône - Hôpital Nord-Ouest

    Villefranche-sur-Saône, France

    Contact Email: •••••@•••••

More trials for these conditions

Other studies related to the condition(s) this trial covers.