Studies

Gelukkig staat de wetenschap niet stil en wordt er in de geneeskunde dagelijks vooruitgang geboekt. De dienst longziekten van AZ-Delta tracht ook hier een actieve rol te spelen oa. door deelname aan een waaier van klinische studies.

Dergelijke klinische studies lopen er momenteel in het domein van oa. astma, COPD en longkanker. Samen met uw huisarts en longarts wordt u de gelegenheid geboden om aan dergelijke studie deel te nemen. Uiteraard is uw deelname volledig vrijblijvend. Een besluit om al dan niet deel te nemen kan slechts worden genomen na voldoende te zijn geinformeerd. Uw longarts en studie-coördinator zullen antwoorden op al uw vragen. 

Aarzel niet om contact met ons op te nemen via 051 / 23 75 04 (Lore) of 051 / 23 72 07 (Melissa).

Klinische studies longkanker AZ Delta – februari 2023

SCLC - small cell lung cancer

Limited disease

KEYLINK-013

Phase 3 Study of Pembrolizumab with Concurrent Chemoradiation Therapy Followed by Pembrolizumab with or without Olaparib Compared to Placebo in newly diagnosed untreated LS-SCLC

Lees meer...
  • Has LS-SCLC, defined as Stage I-III (T any, N any, M0) that can be safely treated with twice-daily RT [45 Gy in 30 twice-daily fractions over 3 weeks], or once-daily RT [60 Gy to 66 Gy in 33 daily fractions over 6 weeks]). 
  • Has not received prior treatment (chemotherapy or radiotherapy or surgery resection)l for LS SCLC
  • Has adequate PFT defined as an FEV1 >50% of predicted normal volume and a DLCO >40% of predicted normal value. 
  • Clearance of 50ml/min
  • Submit pretreatment tumor tissue sample or cytologic sample

 

Extensive disease

20200469: Delphi 303

Phase 1b Study Evaluating the Safety and Efficacy of First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects with Extensive Stage Small Cell Lung

Lees meer...
  • histologically or cytologically confirmed ES-SCLC and no prior systemic treatment for ES-SCLC 
  • Subjects with prior treatment for limited-stage SCLC (LS-SCLC) are permitted 
  • Parts 1 to 4 and 7: Subject must have received 1 cycle of platinum chemotherapy, etoposide, and PD-L1 inhibitor.  
  • Parts 5, 6, 8, and 9: Subjects must have completed 4 cycles of first-line platinum chemotherapy, etoposide, and PD-L1 inhibitor and not have experienced disease progression. 

 

2021004: Delphi 304

A Randomized, Open-label, Phase 3 Study of Tarlatamab Compared With Standard of Care in Subjects with Relapsed Small Cell Lung Cancer After Platinum-based First Line Chemotherapy according to DLL3 expression

Lees meer...
  • progressieve SCLC ES/LS 
    • progression following or during 1line plat based systemic chemo for LS or ES
    • patients who received treatment for LS disease who recur are eligible
    • first line chemo+PDL1inh: patient should have failed on PDL1inh
  • central tissue evaluation (cyto/histo) 

NSCLC - non-small cell lung cancer

Stadium I

Momenteel geen studies open voor inclusie.

 

Stadium II-III

NeoCoast2

A phase 2, open-label, multicenter, randomized study of neoadjuvant and adjuvant treatment in subjects with resectable, early-stage NSCLC

Lees meer...
  • Patients should have resectable (Stage II to Stage IIIA disease.For subjects with N2 disease, only those with 1 single nodal station ≤ 3 cm are eligible) and be candidate for lobectomy, sleeve resection, or bilobectomy at the time of screening
  • No prior exposure to immune-mediated therapy
  • excl: Patients who require preoperative radiotherapy treatment as part of their care plan.
  • Testing for EGFR/ALK is mandatory for subjects with adenocarcinoma or never smokers with squamous histology
  • Availability of pretreatment tumor tissue biopsy 

 

Prediction 

Response and Toxicity Prediction by Microbiome analysis in locally advanced NSCLC treated with IO (durvalumab, MEDI4736) after Chemoradiotherapy

Lees meer...
  • Stages IIIA, IIIB and IIIC NSCLC (histologically or cytologically confirmed)
  • treated with durvalumab treatment after concurrent or sequential chemoradiotherapy 
  • Patients that received neoadjuvant/adjuvant chemotherapy for surgically treated stages I to III NSCLC are allowed as long as therapy was completed at least 6 months prior to the diagnosis of disease recurrence amenable for CRT 
  • resolution of all treatment related toxicity ≤ grade 1
  • No signs of disease progression after chemoradiotherapy 
  • Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of start of Durvalumab are not allowed
  • Active or history of autoimmune disease or immune deficiency is not allowed

 

Stadium IV - 1e lijn

 

INHALED CISPLATIN

A Phase I/IIa First-in-Human Single-arm Open-label Multicentre Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Ascending Doses of a Cisplatin-based Formulation Administered as Dry Powder for Inhalation in Combination with First Line Standard of Care in Patients with Stage IV Non-Small Cell Lung Cancer 

Lees meer...
  • The patient must have a pathologically or cytologically confirmed Stage IV NSCLC that could be treated with pembrolizumab alone or combined with carboplatin/pemetrexed or paclitaxel. 
  • The patient must be treatment naïve for stage IV NSCLC at the time of study enrolment. Patients having received, at least 6 months before D1, platinum derivatives adjuvant after (i) surgery or (ii) concomitant chemotherapy-radiotherapy for unresectable locally advanced NSCLC are eligible.
  • The patient must have a resting oxygen saturation of at least 90%, a FEV1 ≥50% of predicted values as determined by spirometry and a DLCO of at least 50%. 
  • Patients who have received prior radiotherapy within 4 weeks prior to the planned day for the first study treatment administration will be excluded (D1), except palliative radiotherapy (2 weeks). Patients must have recovered from all radiation-related toxicities, not require corticosteroids (see criterion 24) and not have had radiation pneumonitis >grade 2. 
  • Patients using oral corticosteroids within 4 weeks prior to the planned day for the first study treatment administration (D1) above daily dose of 10 mg or any single dose of 16 mg are not eligible. Patients receiving inhaled or topical corticosteroids are eligible. 

 

INHARTED

A Phase I/IIa Single-Arm Open-Label Multicentre Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of (i) Ascending Doses and (ii) Repeated Maximum Tolerated Dose of Cisplatin Administered as Dry Powder for Inhalation in combination with First Line Standard of Care in Patients with stage IV Non-Small Cell Lung Cancer

Lees meer...
  • pathologically or cytologically confirmed Stage IV NSCLC who could be treated with pembrolizumab alone or combined with carboplatin/pemetrexed or paclitaxel
  • patients having undergone pneumonectomy or bilobectomy (except if bilobectomy includes the right middle lobe) are excluded
  • The patient must have a resting oxygen saturation of at least 90%, a FEV1 ≥50% of predicted values as determined by spirometry and a DLCO of at least 50%.
  • Patients with a known history or current evidence of any chronic upper or lower respiratory conditions are excluded
  • Patients with previous history of malignancy provided that patient has been free of disease for at least 3 years may be included.
  • Patients with a known history of a thromboembolic event  within 3 months prior to n (D1). are excluded
  • Patients with a known history of any of the following conditions: presyncope or syncope of either unexplained or cardiovascular etiology, uncontrolled ventricular arrhythmia are excluded
  • creatinine clearance >60 mL/min

 

Long20-06

Development of a blood test for the prediction of response and toxicity to immunotherapy in lung cancer

Lees meer...
  • NSCLC starting with immunotherapy, no corticosteroid use above 8mg/d is allowed

 

TROPION LUNG4

A Phase 1b, Multicenter, 2-Part, Open-Label Study of Datopotamab Deruxtecan (Dato-DXd) in Combination with Immunotherapy with or without Carboplatin in Participants with Advanced or Metastatic Non-Small Cell Lung Cancer (Tropion-Lung04) (Phase 1b Study of Dato-DXd in Combination with Immunotherapy with or without Carboplatin in Advanced or Metastatic Non-Small Cell Lung Cancer)

Lees meer...
  • Histologically or cytologically documented NSCLC
  • stage IIIB or IIIC disease not amenable for surgical resection or defenitive chemoradiation, or Stage IV metastatic NSCLC disease 
  • no prior chemotherapy or other systemic therapy for first-line Stage IIIB, IIIC or IV NSCLC.
  •  Lacks sensitizing EGFR mutation (e.g., exon 19 deletion or exon 21 L858R, exon 21 L861Q, exon 18 G719X, or exon 20 S768I mutation), ALK and ROS1 rearrangement. Has no known genomic alterations in NTRK, BRAF, RET, MET or other actionable driver oncogenes with locally-approved therapies.
  • FFPE tumour sample collected ≤ 3 months prior to signing of informed consent, ie, the
  • start of screening.
  •  Tumour PD-L1 status defined as TC ≥ 50% as assessed prospectively by sponsor
  • designated central laboratory.
  • TROP2 biomarker status as determined prospectively by sponsor designated central
  • laboratory.

 

Stadium IV - 2+ lijn

LATIFY

AstraZeneca’s Phase III open-label randomised multicentre study of  Ceralasertib (ATR kinase inhibitor) plus Durvalumab  versus docetaxel in patients with advanced or metatstatic NSCLC without genomic alterations and whose disease has progressed on or after prior Anti -PDL1 therapy and platinum based chemotherapy

Lees meer...
  • Histologically or cytologically  NSCLC stage IIIB-IV
  • Documented tumour cell PD-L1 status as assessed by a central laboratory: 
  • Documented radiological PD whilst on or after receiving the most recent treatment regimen.
  • must have received an anti-PD-(L)1 therapy and a platinum doublet containing therapy for locally advanced or metastatic NSCLC either separately or in combination. Prior durvalumab is acceptable. 
  • Received a minimum of 8 weeks of an anti-PD-(L)1 and at least 2 cycles of platinum-doublet containing regimen for locally advanced or metastatic NSCLC (either separately or in combination).
  • Radiotherapy: ≥ 4 weeks 
  • Documented EGFR and ALK wild-type status as determined at a local laboratory (SQ and NSQ)

 

A2A-005

A randomized, double-blind, placebo-controlled, Phase 2 study evaluating efficacy and safety of inupadenant (A2A receptor antagonist) in combination with carboplatin and pemetrexed as a second-line therapy in adults with metastatic non-squamous non-small cell lung cancer

Lees meer...
  • Metastatic non-squamous NSCLC patients who have been treated with IO or IO/IO combination only (no chemotherapy) in the metastatic 1L setting and progressed on or after at least 12weeks of anti-PDL1 treatment OR Stage 3 non-squamous unresectable NSCLC patients post Chemoradiotherapy who have been treated with durvalumab and progressed after at least 6 months of treatment. 
  • Can provide existing biopsy taken within 2 years prior to entering trial 
     

 

TROPION LUNG4

A Phase 1b, Multicenter, 2-Part, Open-Label Study of Datopotamab Deruxtecan (Dato-DXd) in Combination with Immunotherapy with or without Carboplatin in Participants with Advanced or Metastatic Non-Small Cell Lung Cancer (Tropion-Lung04) (Phase 1b Study of Dato-DXd in Combination with Immunotherapy with or without Carboplatin in Advanced or Metastatic Non-Small Cell Lung Cancer)

Lees meer...
  • Histologically or cytologically documented NSCLC
  • stage IIIB or IIIC disease not amenable for surgical resection or defenitive chemoradiation, or Stage IV metastatic NSCLC disease 
  • no prior chemotherapy or other systemic therapy for first-line Stage IIIB, IIIC or IV NSCLC.
  •  Lacks sensitizing EGFR mutation (e.g., exon 19 deletion or exon 21 L858R, exon 21 L861Q, exon 18 G719X, or exon 20 S768I mutation), ALK and ROS1 rearrangement. Has no known genomic alterations in NTRK, BRAF, RET, MET or other actionable driver oncogenes with locally-approved therapies.
  • FFPE tumour sample collected ≤ 3 months prior to signing of informed consent, ie, the
  • start of screening.
  •  Tumour PD-L1 status defined as TC ≥ 50% as assessed prospectively by sponsor
  • designated central laboratory.
  • TROP2 biomarker status as determined prospectively by sponsor designated central
  • laboratory.

Mutations

EGFR common mutations

Lat-flosi

Local AblativeTherapy for oligoprogressive Non-Small-Cell lung cancer treated with First-line OSImertinib

Lees meer...
  • Established histological diagnosis of advanced NSCLC, not suitable for radical treatment, with an EGFR actionable mutation receiving first-line targeted TKI therapy with osimertinib
  • Initial radiologically confirmed response (at least stable disease) to osimertinib assessed 3 months post commencing osimertinib according to RECIST criteria v1.1.
  • Confirmed OPD defined as ≤ 3 intra- and extracranial sites of progressive disease. 
  • OP may be defined as progression of an individual metastasis according to RECIST or on 2 consecutive imaging studies at least 2 months apart with a minimum of 5mm increase in size from baseline or an unambiguous development of a new metastatic lesion with a grand total of 3 lesions. All sites must be visible, imaging defined targets, not previously treated with radiation or radiofrequency and suitable for treatment with LAT as determined by the local multi-disciplinary team (MDT).
  • Oligoprogressive metastases not amenable to LAT is not allowed
  • 3. Radiotherapy or radiofrequency ablation near the OP lesion prior to the inclusion in the LAT-FLOSI is not allowed

 

Sapphron

Phase III study in EGFR mutated, MET Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer who have Progressed Following Treatment with Osimertinib, 

Lees meer...
  • Must have at least one documented sensitising EGFR mutation: exon19 deletion, L858R mutation, and/or T790M.
  • EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on first- or second-line treatment with osimertinib as the most recent therapy
  • Participants must be chemotherapy and immunotherapy (i.e., PD-1 inhibitor, PD-L1 inhibitor, T-lymphocyte-associated protein 4 inhibitor) naïve in the metastatic setting
  • clearance ≥ 45 mL/min

 

Lat-flosi

Local ablative therapy of oligoprogressive non-small-cell lung cancer treated with first-line osimertinib

Lees meer...
  • Established histological diagnosis of advanced NSCLC, not suitable for radical treatment, + EGFR actionable mutation receiving first-line targeted TKI therapy with osimertinib
  • Initial radiologically confirmed response (at least stable disease) to osimertinib assessed 3 months post commencing osimertinib according to RECIST criteria v1.1.
  • Confirmed PD defined as ≤ 3 intra- and extracranial sites of progressive disease

 

BAY29727088/21607 

An open label, first-in-human study of BAY 2927088 in participants with advanced non-small cell lung cancer (NSCLC) harboring an EGFR and/or HER2 mutation

Lees meer...
  • NSCLC stage IIIB-IV+ HER mutation

 

HER2mutations

 

REZILIENT 

Randomized, Controlled, Open-label, Phase 3, Global Multi-Center Trial to Assess the Efficacy and Safety of Zipalertinib plus Chemotherapy versus Chemotherapy alone, in Patients with Previously Untreated, Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations.

Lees meer...
  • Stadium IV AdenoCA, niet voordien behandeld, met EGFR ex20ins mutatie

 

METexon14 skipping mutation

Moment

Disease registry on patients with advanced non-small cell lung cancer harboring METex14 skiping alterations

Lees meer...
  • NSCLC starting with immunotherapy, no corticosteroid use above 8mg/d is allowed

 

CMET

SWAT:Study M21‐404

Advanced Solid Tumors: ABBV‐400 as Monotherapy – A Global First‐in‐HumanStudy: A Phase 1 first in human study evaluating safety, pharmacokinetics and efficacy of ABBV-400 in adult subjects with advanced solid tumors

Lees meer...
  • availability of t umor tissue 
  • Part 1 only: NSCLC, who have progressed on standard of care therapy and are not amenable to surgical resection or other approved therapeutic options t
  • Part 2 only: Subjects with advanced c-Met overexpressing non-squamous or squamous NSCLC as assessed by a central laboratory
  • This includes subjects who have progressed after treatment with at least: 
  • Platinum-based chemotherapy and an immune checkpoint inhibitor or appropriate targeted therapy, 
  • Parts 2a: c-Met intermediate/high non-squamous wtEGFR NSCLC
  • 2b mutated EGFR-expression (mutEGFR NSCLC)
  • 2c: c-Met low non-squamous wtEGFR NSCLC
  • 2d: c-Met overexpressing squamous NSCLC
     

 

KRASG12C mutation

KontRASt-06

An open-label phase II trial evaluating the activity and safety of JDQ443 single-agent as first-line treatment for subjects with locally advanced or metastatic KRAS G12C mutant non-small cell lung cancer with PD-L1 expression

Lees meer...
  • Cohort A: subjects whose tumors harbor a KRAS G12C mutation and a low (<1%)PD-L1 expression.
  • Cohort B: subjects whose tumors harbor a KRAS G12C mutation, a positive (≥1%)PD-L1 expression and a STK11 co-mutation
  • histologically confirmed locally advanced (stage IIIb/IIIc ineligible for definitive chemoradiation or surgery) or metastatic (stage IV) NSCLC subjects without previous systemic treatment for metastatic disease. Prior treatment with (neo)adjuvant platinum-doublet chemotherapy and/or an immune checkpoint inhibitor administered before and/or after surgery or concomitantly/sequentially with radiation therapy with recurrence after 12 months of therapy completion is allowed. 
  • Presence of a KRAS G12C mutation determined by local testing ( or centrally at a Novartis designated laboratory prior to enrolment
  • Mandatory provision of a FFPE tumor tissue sample for central evaluation

 

Krascendo 

A phase IB/II, open-label, multicenter study evaluating the safety , activity and pharmacokinetics of GDC-6036 in combination with other anti-cancer therapies in patients with previously untreated advanced or metastatic non-small cell lung cancer with a KRAS G12C mutation

Lees meer...
  • Documented history of the KRAS G12C mutation
  • Documented history of PD-L1 tumor cell expression ≥1%
  • Pre-treatment tumor tissue along with an associated pathology report is required for all participants enrolled on study
  • No prior systemic treatment for advanced unresectable or metastatic NSCLC
  • Measurable disease, as defined by RECIST v1.1
  • History of leptomeningeal disease is excluded
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases are excluded

 

RET-fusion

Libretto-432/JZJX

A Placebo-controlled Double-Blinded Randomized Phase 3 Study of Adjuvant Selpercatinib following Definitive Locoregional Treatment in Participants with Stage IB-IIIA RET fusion-Positive NSCLC

Lees meer...
  • Must have histologically confirmed Stage IB, II, or IIIA NSCLC
  • Must have an activating RET gene fusion in tumor PCR or NGS
  • Must have received definitive locoregional therapy with curative intent (surgery or radiotherapy) for Stage IB, II, or IIIA NSCLC. Receipt of prior systemic anti anti-cancer therapy is allowed but not required.

IPF – idiopathische longfibrose

 

MOONSCAPE-studie

A TWO-COHORT, PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF VIXARELIMAB COMPARED WITH PLACEBO IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS AND IN PATIENTS WITH SYSTEMIC SCLEROSIS ASSOCIATED INTERSTITIAL LUNG DISEASE 

Lees meer...
  • 45 – 85 years
  • FVC ≥ 45%
  • DLCO ≥ 30% en ≤90% of predicted during screening (Hgb corrected)
  • 6MWT distance of 150 meters with maximum use of 6 l/min at sea level
  • Treatment naive patients for ≥4 months  or treatment with antifibrotics for at least ≥3 months with a stable dose for ≥4 weeks.

COPD

ALIENTO

A PHASE IIb, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ASTEGOLIMAB IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE 

Lees meer...
  • 40 – 90 years
  • COPD diagnosis for at least 12 months
    • FEV1 >20% and ≤ 80%
  • History of frequent exacerbations, defined as having had two or more moderate or severe exacerbations occurring within a 12-month period in the 24 months prior to screening 
  • Current smokers or former smokers
    • LABA/ICS or LABA/LAMA or LABA/LAMA/ICS
  • History of one of the following combinations of optimized, stable, standard-of-care COPD maintenance therapy for at least 4 weeks prior to screening, with no anticipated changes in therapy prior to initiation of study drug and throughout the study: 

 

MIRANDA

Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tozorakimab in Participants with Symptomatic Chronic Obstructive Pulmonary Disease (COPD) with a History of COPD Exacerbations (MIRANDA)

Lees meer...
  • > 40 years
  • ≥ 2 moderate or ≥ 1 severe COPD exacerbations within the last 12 months
  • Stable treatment (3 months) with ICS/LABA/LAMA or dual therapy
  • ≥ 10 pack years
  • CAT total score ≥ 10
  • 70% complaince with COPD maintenance therapy

 

ALNASA

A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF ASTEGOLIMAB IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE 

Lees meer...
  • Completion of the 52-week treatment period in the ALIENTO study 

ANDERE

 

TILIA

A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tozorakimab (MEDI3506) in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen (TILIA)

Lees meer...
  • Adult participants  18 years old at the time of signing the ICF.
  • Patients hospitalised with viral lung infection. Note: Suspected viral aetiology is
  • acceptable to meet this criterion.
  • Hypoxaemia requiring treatment with supplemental O2, consistent with WHO Clinical
  • Progression Scale for Disease Progression score of 5 and 6.
  • Note: Hypoxemia is defined as SpO2  94% on room air at screening, or documented
  • SpO2  94% prior to initiation of oxygen therapy. Patients receiving oxygen > 6 L/min
  • or non-invasive ventilation will be considered to have met this inclusion criterion
  • regardless of SpO2 levels.
  • 36 hours since admission to hospital.
  • 14 days since onset of respiratory viral infection symptoms.