BridgeMD
Trial assessing treatment in patients with advanced Lung Cancer and Interstitial Lung Disease
EU CTIS ID: 2025-522790-10-00
What this study is testing
1rst line : Efficacy of carboplatine and weekly paclitaxel +/- bevacizumab for advanced NSCLC patients with ILD. 2nd line : Assessment of respiratory toxicity of treatment in ARM A (best investigator choice chemotherapy) and in ARM B (i.e of pembrolizumab or nivolumab) as second-line treatment for advanced NSCLC patients with non-severe ILD.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
- 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 UNL except for patients with liver metastases (< 5x UNL); total bilirubin ≤ 1.5x UNL except for patients with proven Gilbert's syndrome (≤ 5x UNL) or patients with liver metastases (≤ 3.0 mg/dL).
- Life expectancy of at least 12 weeks.
- 1st line only: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.
- 1st line only: ILD criteria: any type of ILD and any level of severity are allowed
You likely can't join if
- Small cell cancer or tumor with mixed histology including a small cell component.
- 2nd line only : 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.
- 2nd line only : 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.
- 2nd line only: More than one line of treatment
- 2nd line only: any prior Immunotherapy
- 2nd line only: Patients who have had major surgery ≤ 3 weeks before randomization.
See the full eligibility criteria
Who can join
- 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.
- 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 UNL except for patients with liver metastases (< 5x UNL); total bilirubin ≤ 1.5x UNL except for patients with proven Gilbert's syndrome (≤ 5x UNL) or patients with liver metastases (≤ 3.0 mg/dL).
- Life expectancy of at least 12 weeks.
- 1st line only: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.
- 1st line only: ILD criteria: any type of ILD and any level of severity are allowed
- 2nd line only: 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.
- 2nd line only: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.
- 2nd line only: 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.
- 2nd line only: 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.
- 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
- 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-irradiable/non-irradiated or IV (8th TNM classification, UICC 2015). For other less advanced stages but rejected for any local treatment, possible inclusion discussion with the sponsor
What rules you out
- Small cell cancer or tumor with mixed histology including a small cell component.
- 2nd line only : 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.
- 2nd line only : 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.
- 2nd line only: More than one line of treatment
- 2nd line only: any prior Immunotherapy
- 2nd line only: Patients who have had major surgery ≤ 3 weeks before randomization.
- 2nd line only : Corticosteroid therapy > 10 mg daily oral prednisone or equivalent.
- 2nd line only : Immunosuppressive therapy within two weeks prior to randomization.
- Known EGFR activating mutation (deletion LREA in exon 19, mutation L858R or L861X in exon 21, mutation G719A/S in exon 18). Known rearrangement of ALK or ROS1 genes evaluated by immunohistochemistry, FISH or NGS sequencing.
- 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.
- 1rst line only : Previous systemic therapy (including but not limited to chemotherapy, targeted therapy, immunotherapy) except for adjuvant therapies given more than 5 years ago
- 2nd line only : 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.
- 2nd line only : Diagnosis of interstitial lung disease with manifestations of autoimmunity (IPAF) according to ATS/ERS criteria
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.