A phase 1b study of an autologous dendritic cell immunotherapy in combination with anti-programmed death-1 treatment in patients with metastatic non-small-cell lung cancer (DARE-LUNG)

2025-521577-13-00 Protocol DARE-LUNG Human pharmacology (Phase I) - First administration to humans Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 1 sites · Protocol DARE-LUNG

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - First administration to humans
Status Authorised, recruitment pending
Participants planned 64
Countries 1
Sites 1

metastatic non-small-cell lung cancer

To assess the overall safety of preparing and administering MIDRIX-LUNG-00x in combination with anti-PD-1 therapy in metastatic NSCLC patients.

Key facts

Sponsor
Universitair Ziekenhuis Gent
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Decision date (initial)
2025-08-25
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
FICO · Kom Op Tegen Kanker

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

To assess the overall safety of preparing and administering MIDRIX-LUNG-00x in combination with anti-PD-1 therapy in metastatic NSCLC patients.

Secondary objectives 4

  1. To assess the correlation between the observed antigen-specific immune responses and the CTAG expression profile in the patient’s tumor (provided enough tissue is available).
  2. To assess acute systemic inflammatory reactions to MIDRIX-LUNG-00x injection.
  3. To assess the molecular response of the tumor to MIDRIX-LUNG-00x injection.
  4. To investigate global peripheral blood immunoreactomes before, during and after the MIDRIX-LUNG-00x treatment phase.

Conditions and MedDRA coding

metastatic non-small-cell lung cancer

VersionLevelCodeTermSystem organ class
27.1 PT 10059515 Non-small cell lung cancer metastatic 100000004864

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 23

  1. Before patient screening, written informed consent must be given for the interventional study according to ICH/GCP and institutional practice.
  2. Male or female participants age ≥ 18 years at screening.
  3. For female participants with child-bearing potential, the willingness to follow contraceptive guidance and pregnancy testing during the projected duration of the trial (see Appendix B for Contraceptive Guidance and Pregnancy Testing). Female participants must have a negative serum pregnancy test at screening.
  4. For male participants having a partner with child-bearing potential: agreement to use contraception during the projected duration of the trial, starting with the screening visit through 90 days after the last dose of trial treatment. Sperm donation must have been performed before anti-cancer treatment as per standard practice.
  5. Histologically or cytologically proven diagnosis of NSCLC, newly diagnosed or recurrent stage IV, or stage IIIB-C not amenable to radical chemoradiotherapy (per AJCC 9th Edition).
  6. Substudy I: non-squamous histology: Cohort 1: metastatic or locally advanced NSCLC that will start on an anti-PD-1 therapy-containing regimen. Cohort 1A: pembrolizumab or cemiplimab monotherapy (PD-L1 TPS ≥ 50%).
  7. Substudy I: non-squamous histology: Cohort 1: metastatic or locally advanced NSCLC that will start on an anti-PD-1 therapy-containing regimen. Cohort 1B: cisplatin/carboplatin-pemetrexed-pembrolizumab or cisplatin/carboplatin-pemetrexed-cemiplimab.
  8. Substudy I: non-squamous histology: Cohort 2: metastatic or locally advanced NSCLC not progressive after completion of induction with cisplatin/carboplatin-pemetrexed-pembrolizumab or cisplatin/carboplatin-pemetrexed-cemiplimab. Maintenance pemetrexed is allowed per investigator’s choice.
  9. Substudy I: non-squamous histology: Cohort 3: metastatic or locally advanced NSCLC progressive (including immune unconfirmed progressive disease) on anti-PD-1 monotherapy or in the maintenance phase of an anti-PD-1 therapy-containing regimen per SOC, and fulfilling the criteria of treatment beyond progression1. Patients must have had stable disease or a partial response as best response on prior anti-PD-1 therapy. Cohort 3A: progressing on anti-PD-1 monotherapy, e.g. pembrolizumab or cemiplimab (PD-L1 TPS ≥ 50%, no previous platinum-based chemotherapy).
  10. Substudy I: non-squamous histology: Cohort 3: metastatic or locally advanced NSCLC progressive (including immune unconfirmed progressive disease) on anti-PD-1 monotherapy or in the maintenance phase of an anti-PD-1 therapy-containing regimen per SOC, and fulfilling the criteria of treatment beyond progression1. Patients must have had stable disease or a partial response as best response on prior anti-PD-1 therapy. Cohort 3B: progressing in the maintenance phase of an anti-PD-1 therapy-containing regimen, e.g. cisplatin/carboplatin-pemetrexed-pembrolizumab or cisplatin/carboplatin-pemetrexed-cemiplimab.
  11. Substudy I: non-squamous histology: Cohort 4: metastatic or locally advanced NSCLC previously treated with an anti-PD-1 therapy-containing regimen that was discontinued after a maximum duration per SOC and eligible for anti-PD-1 therapy.
  12. Substudy II: squamous histology: Cohort 1: metastatic NSCLC that will start on an anti-PD-1 therapy-containing regimen. Cohort 1A: pembrolizumab or cemiplimab monotherapy (PD-L1 TPS ≥ 50%).
  13. Substudy II: squamous histology: Cohort 1: metastatic NSCLC that will start on an anti-PD-1 therapy-containing regimen. Cohort 1B: carboplatin-paclitaxel-pembrolizumab or carboplatin-paclitaxel-cemiplimab.
  14. Substudy II: squamous histology: Cohort 2: metastatic NSCLC not progressive after completion of induction with carboplatin-paclitaxel-pembrolizumab or carboplatin-paclitaxel-cemiplimab.
  15. Substudy II: squamous histology: Cohort 3: metastatic or locally advanced NSCLC progressive (including immune unconfirmed progressive disease) on anti-PD-1 monotherapy or in the maintenance phase of an anti-PD-1 therapy-containing regimen per SOC, and fulfilling the criteria of treatment beyond progression1. Patients must have had stable disease or a partial response as best response on prior anti-PD-1 therapy. Cohort 3A: progressing on anti-PD-1 monotherapy, e.g. pembrolizumab or cemiplimab (PD-L1 TPS ≥ 50%, no previous platinum-based chemotherapy).
  16. Substudy II: squamous histology: Cohort 3: metastatic or locally advanced NSCLC progressive (including immune unconfirmed progressive disease) on anti-PD-1 monotherapy or in the maintenance phase of an anti-PD-1 therapy-containing regimen per SOC, and fulfilling the criteria of treatment beyond progression1. Patients must have had stable disease or a partial response as best response on prior anti-PD-1 therapy. Cohort 3B: progressing in the maintenance phase of an anti-PD-1 therapy-containing regimen, e.g. carboplatin-paclitaxel-pembrolizumab or carboplatin-paclitaxel-cemiplimab.
  17. Substudy II: squamous histology: Cohort 4: metastatic NSCLC previously treated with an anti-PD-1 therapy-containing regimen that was discontinued after a maximum duration per SOC and eligible for anti-PD-1 therapy.
  18. At least 1 measurable lesion per RECIST v1.1 at screening.
  19. ECOG performance status 0 to 1.
  20. Estimated life-expectancy > 12 weeks.
  21. Documented brain metastasis must be either asymptomatic or stabilized after adequate radiotherapeutic treatment as per institutional practice.
  22. Adequate organ function, including:1. Adequate bone marrow reserve: absolute neutrophil count > 1500/μL, platelet count > 100000/μL, and Hb > 9.0 g/dL. 2. For patients receiving chemotherapy, adequate renal function as defined by eGFR > 45 mL/min according to the Cockcroft-Gault formula. 3. Adequate hepatic function as defined by total bilirubin ≤ 1.5 x upper limit of normal (ULN) OR direct bilirubin within normal limits for participants with total bilirubin levels >1.5 x ULN; AST and ALT ≤ 3 x ULN or ≤ 5 x ULN if there is liver involvement by the tumor.
  23. For Leukapheresis: Having passed all tests defined in the institutional Leukapheresis Donor Fitness Screening, including:1. Adequate peripheral vein access to perform leukapheresis. 2. Adequate coagulation function defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless the participant is receiving anticoagulant therapy. In this case, these criteria are not applicable or cannot be evaluated. 3. Negative test results for HBs-antigen, anti-HBc-serology, anti-HCV serology, anti-HIV1-2 serology, anti-CMV IgM, anti-Syphilis (Treponema pallidum) serology. 4.Negative test results for Epstein-Barr virus (IgM) and for Toxoplasmosis (IgM). 5. For female participants: a negative serum beta-HCG test result within 28 days before the day of leukapheresis.

Exclusion criteria 24

  1. Presence of oncogenic driver genomic alterations (EGFR, ALK, ROS1, RET, BRAF V600, NTRK, MET, HER2), as determined by existing local test results, for which a targeted therapy is available. Patients with KRAS mutations, including KRAS G12C mutations, are eligible if no targeted therapy is available at the time of screening.
  2. For cohort 3: progressive disease as best response to anti-PD-1 therapy (primary resistance) or clinical or radiographic signs of hyperprogressive disease.
  3. Concomitant participation in another clinical interventional trial. Subjects who are participating in another interventional trial and have completed the progression-free survival follow-up are eligible.
  4. NSCLC with large-cell neuro-endocrine or sarcomatoid histology.
  5. Prior malignancy, except for adequately treated non-melanoma skin carcinoma, in situ cancer of the bladder or the cervix, localized prostate cancer, ductal breast carcinoma in situ, or any other cancer for which the patient has been disease-free for at least two years.
  6. Untreated brain metastases with neurological symptoms or brain metastasis requiring a daily intake of steroids of > 10 mg oral prednisolone or equivalent.
  7. Leptomeningeal disease.
  8. Persistent toxicities > CTCAE grade 2, including immune related adverse events (irAE), caused by a previous anticancer therapy.
  9. Disease requiring chronic treatment with systemic glucocorticosteroids with a daily dose > 10 mg oral prednisolone or equivalent. Inhaled corticosteroids and topical corticosteroids on skin sites are allowed.
  10. Autoimmune disease requiring treatment with immunosuppressive medication at the time of the study. 1.Patients with a history of auto-immune hypothyroidism on a stable dose of thyroid hormone replacement may be eligible. 2. Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible. 3. Patients with eczema, psoriasis, lichen simplex, or vitiligo with dermatologic manifestations only may be eligible provided the disease is well controlled at screening and only requires low potency topical steroids.
  11. Any chronic or active concomitant infection (bacterial, viral, fungal) that is uncontrolled or requires systemic therapy.
  12. Known infection with hepatitis B (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection.
  13. Active tuberculosis.
  14. Prior allogeneic stem cell or solid organ transplantation.
  15. Interstitial lung disease.
  16. Known hypersensitivity or allergy to one of the vaccine substances.
  17. Chronic comorbidity (such as asthma, COPD, heart failure, renal failure, arterial hypertension or diabetes mellitus) that is uncontrolled or not stabilized under medication at the time of study enrolment, or stable yet severe enough to constitute an unwarranted high risk for the investigational cellular therapy.
  18. For female participants: pregnancy or lactation or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 90 days after the last dose of trial treatment.
  19. Any organic brain syndrome or other significant psychiatric abnormality which would comprise the ability to give informed consent and preclude participation in the full protocol and follow-up.
  20. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before enrolment in the trial.
  21. Prior treatment with autologous or allogeneic dendritic cell-based vaccines.
  22. Prior treatment with anti-CTLA-4 therapy or anti-PD-L1 therapy for metastatic NSCLC.
  23. Receipt of a live attenuated vaccine within 30 days prior to the first dose of study intervention. Note: participants, if enrolled, should not receive a live attenuated vaccine while receiving study intervention and up to 30 days after the last dose of study intervention.
  24. Participants who have received more than one line of prior anti-PD-(L)1 therapy, either alone or in any combination, are excluded except with the following exception: Patients who completed treatment with an anti-PD-(L)1 therapy for locally advanced NSCLC after chemoradiotherapy or as a (neo-)adjuvant therapy for resectable NSCLC, and are subsequently treated with an anti-PD-1 therapy for metastatic disease, may be included.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Toxicity as defined by the Common Toxicity Criteria for Adverse Events version 5.0 (CTCAE v.5.0). Toxicity will be assessed during the interventional treatment phase of the trial from leukapheresis until three months after the last vaccine dose.

Secondary endpoints 4

  1. Overall response rate (ORR%) based on investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; duration of response; median progression-free survival (mPFS, months); 1-year PFS (%) based on investigator assessment per RECIST 1.1; median overall survival (mOS, months); 1-year OS (%).
  2. Vaccine-induced immune responses as measured by in vitro immunomonitoring tests (antigen-specific T-cell reactivity). Immune responses will be measured after each DC vaccination and at prespecified timepoints during the follow-up period.
  3. Success rate (%) of manufacturing sufficient DCs for vaccination, which is defined as the production of DC aliquots for ≥ 3 vaccination rounds.
  4. Health-related quality of life by means of the EORTC QLQ-C30 and EORTC QLQ-LC29 questionnaires, measured before and during the interventional treatment phase of the trial.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 39

Pemetrexed Accord 500 mg powder for concentrate for solution for infusion.

PRD3642990 · Product

Active substance
Pemetrexed
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
500 mg/m2 milligram(s)/square meter
Max total dose
52000 mg/m2 milligram(s)/square meter
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01BA04 — -
Marketing authorisation
EU/1/15/1071/002
MA holder
ACCORD HEALTHCARE S.L.U.
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pemetrexed Accord 1000 mg powder for concentrate for solution for infusion.

PRD3642991 · Product

Active substance
Pemetrexed
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
500 mg/m2 milligram(s)/square meter
Max total dose
52000 mg/m2 milligram(s)/square meter
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01BA04 — -
Marketing authorisation
EU/1/15/1071/003
MA holder
ACCORD HEALTHCARE S.L.U.
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pemetrexed Accord 100 mg powder for concentrate for solution for infusion.

PRD3642989 · Product

Active substance
Pemetrexed
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
500 mg/m2 milligram(s)/square meter
Max total dose
52000 mg/m2 milligram(s)/square meter
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01BA04 — -
Marketing authorisation
EU/1/15/1071/001
MA holder
ACCORD HEALTHCARE S.L.U.
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pemetrexed Accord 1000 mg powder for concentrate for solution for infusion.

PRD3642985 · Product

Active substance
Pemetrexed
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
500 mg/m2 milligram(s)/square meter
Max total dose
52000 mg/m2 milligram(s)/square meter
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01BA04 — -
Marketing authorisation
EU/1/15/1071/003
MA holder
ACCORD HEALTHCARE S.L.U.
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pemetrexed Accord 1000 mg powder for concentrate for solution for infusion.

PRD3636608 · Product

Active substance
Pemetrexed
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
500 mg/m2 milligram(s)/square meter
Max total dose
52000 mg/m2 milligram(s)/square meter
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01BA04 — -
Marketing authorisation
EU/1/15/1071/003
MA holder
ACCORD HEALTHCARE S.L.U.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pemetrexed Accord 500 mg powder for concentrate for solution for infusion.

PRD3642984 · Product

Active substance
Pemetrexed
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
500 mg/m2 milligram(s)/square meter
Max total dose
52000 mg/m2 milligram(s)/square meter
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01BA04 — -
Marketing authorisation
EU/1/15/1071/002
MA holder
ACCORD HEALTHCARE S.L.U.
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pemetrexed Accord 1000 mg powder for concentrate for solution for infusion.

PRD3642988 · Product

Active substance
Pemetrexed
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
500 mg/m2 milligram(s)/square meter
Max total dose
52000 mg/m2 milligram(s)/square meter
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01BA04 — -
Marketing authorisation
EU/1/15/1071/003
MA holder
ACCORD HEALTHCARE S.L.U.
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pemetrexed Accord 100 mg powder for concentrate for solution for infusion.

PRD3636606 · Product

Active substance
Pemetrexed
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
500 mg/m2 milligram(s)/square meter
Max total dose
52000 mg/m2 milligram(s)/square meter
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01BA04 — -
Marketing authorisation
EU/1/15/1071/001
MA holder
ACCORD HEALTHCARE S.L.U.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pemetrexed Accord 500 mg powder for concentrate for solution for infusion.

PRD3636607 · Product

Active substance
Pemetrexed
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
500 mg/m2 milligram(s)/square meter
Max total dose
52000 mg/m2 milligram(s)/square meter
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01BA04 — -
Marketing authorisation
EU/1/15/1071/002
MA holder
ACCORD HEALTHCARE S.L.U.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pemetrexed Accord 100 mg powder for concentrate for solution for infusion.

PRD3642983 · Product

Active substance
Pemetrexed
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
500 mg/m2 milligram(s)/square meter
Max total dose
52000 mg/m2 milligram(s)/square meter
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01BA04 — -
Marketing authorisation
EU/1/15/1071/001
MA holder
ACCORD HEALTHCARE S.L.U.
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pemetrexed Accord 100 mg powder for concentrate for solution for infusion.

PRD3642986 · Product

Active substance
Pemetrexed
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
500 mg/m2 milligram(s)/square meter
Max total dose
52000 mg/m2 milligram(s)/square meter
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01BA04 — -
Marketing authorisation
EU/1/15/1071/001
MA holder
ACCORD HEALTHCARE S.L.U.
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

KEYTRUDA 25 mg/mL concentrate for solution for infusion

PRD4323105 · Product

Active substance
Pembrolizumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
200 mg milligram(s)
Max total dose
20800 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01FF02 — -
Marketing authorisation
EU/1/15/1024/002
MA holder
MERCK SHARP & DOHME B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

KEYTRUDA 25 mg/mL concentrate for solution for infusion

PRD4323784 · Product

Active substance
Pembrolizumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
200 mg milligram(s)
Max total dose
20800 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01FF02 — -
Marketing authorisation
EU/1/15/1024/002
MA holder
MERCK SHARP & DOHME B.V.
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

KEYTRUDA 25 mg/mL concentrate for solution for infusion

PRD4323785 · Product

Active substance
Pembrolizumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
200 mg milligram(s)
Max total dose
20800 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01FF02 — -
Marketing authorisation
EU/1/15/1024/002
MA holder
MERCK SHARP & DOHME B.V.
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

KEYTRUDA 25 mg/mL concentrate for solution for infusion

PRD4323786 · Product

Active substance
Pembrolizumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
200 mg milligram(s)
Max total dose
20800 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01FF02 — -
Marketing authorisation
EU/1/15/1024/002
MA holder
MERCK SHARP & DOHME B.V.
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Paclitaxel Fresenius Kabi 6 mg/ml concentraat voor oplossing voor infusie

PRD11870207 · Product

Active substance
Paclitaxel
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
175 mg/m2 milligram(s)/square meter
Max total dose
700 mg/m2 milligram(s)/square meter
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
L01CD01 — PACLITAXEL
Marketing authorisation
RVG101863
MA holder
FRESENIUS KABI NEDERLAND B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Paclitaxel Fresenius Kabi 6 mg/ml concentraat voor oplossing voor infusie

PRD409125 · Product

Active substance
Paclitaxel
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
175 mg/m2 milligram(s)/square meter
Max total dose
700 mg/m2 milligram(s)/square meter
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
L01CD01 — PACLITAXEL
Marketing authorisation
RVG101863
MA holder
FRESENIUS KABI NEDERLAND B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Paclitaxel Fresenius Kabi 6 mg/ml concentraat voor oplossing voor infusie

PRD11870205 · Product

Active substance
Paclitaxel
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
175 mg/m2 milligram(s)/square meter
Max total dose
700 mg/m2 milligram(s)/square meter
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
L01CD01 — PACLITAXEL
Marketing authorisation
RVG101863
MA holder
FRESENIUS KABI NEDERLAND B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Paclitaxel Fresenius Kabi 6 mg/ml concentraat voor oplossing voor infusie

PRD11870210 · Product

Active substance
Paclitaxel
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
175 mg/m2 milligram(s)/square meter
Max total dose
700 mg/m2 milligram(s)/square meter
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
L01CD01 — PACLITAXEL
Marketing authorisation
RVG101863
MA holder
FRESENIUS KABI NEDERLAND B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Paclitaxel Fresenius Kabi 6 mg/ml concentraat voor oplossing voor infusie

PRD11870211 · Product

Active substance
Paclitaxel
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
175 mg/m2 milligram(s)/square meter
Max total dose
700 mg/m2 milligram(s)/square meter
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
L01CD01 — PACLITAXEL
Marketing authorisation
RVG101863
MA holder
FRESENIUS KABI NEDERLAND B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Paclitaxel Fresenius Kabi 6 mg/ml concentraat voor oplossing voor infusie

PRD11870204 · Product

Active substance
Paclitaxel
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
175 mg/m2 milligram(s)/square meter
Max total dose
700 mg/m2 milligram(s)/square meter
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
L01CD01 — PACLITAXEL
Marketing authorisation
RVG101863
MA holder
FRESENIUS KABI NEDERLAND B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Paclitaxel Fresenius Kabi 6 mg/ml concentraat voor oplossing voor infusie

PRD11870209 · Product

Active substance
Paclitaxel
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
175 mg/m2 milligram(s)/square meter
Max total dose
700 mg/m2 milligram(s)/square meter
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
L01CD01 — PACLITAXEL
Marketing authorisation
RVG101863
MA holder
FRESENIUS KABI NEDERLAND B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Paclitaxel Fresenius Kabi 6 mg/ml concentraat voor oplossing voor infusie

PRD11870203 · Product

Active substance
Paclitaxel
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
175 mg/m2 milligram(s)/square meter
Max total dose
700 mg/m2 milligram(s)/square meter
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
L01CD01 — PACLITAXEL
Marketing authorisation
RVG101863
MA holder
FRESENIUS KABI NEDERLAND B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Paclitaxel Fresenius Kabi 6 mg/ml concentraat voor oplossing voor infusie

PRD11870208 · Product

Active substance
Paclitaxel
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
175 mg/m2 milligram(s)/square meter
Max total dose
700 mg/m2 milligram(s)/square meter
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
L01CD01 — PACLITAXEL
Marketing authorisation
RVG101863
MA holder
FRESENIUS KABI NEDERLAND B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Paclitaxel Fresenius Kabi 6 mg/ml concentraat voor oplossing voor infusie

PRD11870206 · Product

Active substance
Paclitaxel
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
175 mg/m2 milligram(s)/square meter
Max total dose
700 mg/m2 milligram(s)/square meter
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
L01CD01 — PACLITAXEL
Marketing authorisation
RVG101863
MA holder
FRESENIUS KABI NEDERLAND B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

MIDRIX-LUNG-002

PRD12544184 · Product

Active substance
MIDRIX-LUNG-002
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENUS USE
Max daily dose
45000000 Other
Max total dose
180000000 Other
Max treatment duration
14 Week(s)
Authorisation status
Not Authorised
MA holder
UNIVERSITAIR ZIEKENHUIS GENT
Paediatric formulation
No
Orphan designation
No

LIBTAYO 350 mg concentrate for solution for infusion.

PRD7478447 · Product

Active substance
Cemiplimab
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
350 mg milligram(s)
Max total dose
36400 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01FF06 — -
Marketing authorisation
EU/1/19/1376/001
MA holder
REGENERON IRELAND D.A.C.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

LIBTAYO 350 mg concentrate for solution for infusion.

PRD7514335 · Product

Active substance
Cemiplimab
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
350 mg milligram(s)
Max total dose
36400 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01FF06 — -
Marketing authorisation
EU/1/19/1376/001
MA holder
REGENERON IRELAND D.A.C.
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

LIBTAYO 350 mg concentrate for solution for infusion.

PRD7514333 · Product

Active substance
Cemiplimab
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
350 mg milligram(s)
Max total dose
36400 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01FF06 — -
Marketing authorisation
EU/1/19/1376/001
MA holder
REGENERON IRELAND D.A.C.
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

LIBTAYO 350 mg concentrate for solution for infusion.

PRD7514334 · Product

Active substance
Cemiplimab
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
350 mg milligram(s)
Max total dose
36400 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01FF06 — -
Marketing authorisation
EU/1/19/1376/001
MA holder
REGENERON IRELAND D.A.C.
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cisplatine Accord 1 mg/ml concentraat voor oplossing voor infusie

PRD1951586 · Product

Active substance
Cisplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
80 mg/m2 milligram(s)/square meter
Max total dose
320 mg/m2 milligram(s)/square meter
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
L01XA01 — CISPLATIN
Marketing authorisation
RVG 104068
MA holder
ACCORD HEALTHCARE B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cisplatine Accord 1 mg/ml concentraat voor oplossing voor infusie

PRD1951587 · Product

Active substance
Cisplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
80 mg/m2 milligram(s)/square meter
Max total dose
320 mg/m2 milligram(s)/square meter
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
L01XA01 — CISPLATIN
Marketing authorisation
RVG 104068
MA holder
ACCORD HEALTHCARE B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cisplatine Accord 1 mg/ml concentraat voor oplossing voor infusie

PRD1951585 · Product

Active substance
Cisplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
80 mg/m2 milligram(s)/square meter
Max total dose
320 mg/m2 milligram(s)/square meter
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
L01XA01 — CISPLATIN
Marketing authorisation
RVG 104068
MA holder
ACCORD HEALTHCARE B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cisplatine Accord 1 mg/ml concentraat voor oplossing voor infusie

PRD1951623 · Product

Active substance
Cisplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
80 mg/m2 milligram(s)/square meter
Max total dose
320 mg/m2 milligram(s)/square meter
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
L01XA01 — CISPLATIN
Marketing authorisation
RVG 104068
MA holder
ACCORD HEALTHCARE B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

MIDRIX-LUNG-001

PRD12542716 · Product

Active substance
MIDRIX-LUNG-001
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
45000000 Other
Max total dose
180000000 Other
Max treatment duration
14 Week(s)
Authorisation status
Not Authorised
MA holder
UNIVERSITAIR ZIEKENHUIS GENT
Paediatric formulation
No
Orphan designation
No

Carboplatin Accord 10 mg/ml concentraat voor oplossing voor infusie

PRD2005416 · Product

Active substance
Carboplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
120 mg/m2 milligram(s)/square meter
Max total dose
480 mg/m2 milligram(s)/square meter
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
L01XA02 — CARBOPLATIN
Marketing authorisation
RVG 100101
MA holder
ACCORD HEALTHCARE B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Carboplatin Accord 10 mg/ml, concentraat voor oplossing voor infusie

PRD415290 · Product

Active substance
Carboplatin
Pharmaceutical form
CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
120 mg/m2 milligram(s)/square meter
Max total dose
480 mg/m2 milligram(s)/square meter
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
L01XA02 — CARBOPLATIN
Marketing authorisation
RVG 100101
MA holder
ACCORD HEALTHCARE B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Carboplatin Accord 10 mg/ml, concentraat voor oplossing voor infusie

PRD2005415 · Product

Active substance
Carboplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
120 mg/m2 milligram(s)/square meter
Max total dose
480 mg/m2 milligram(s)/square meter
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
L01XA02 — CARBOPLATIN
Marketing authorisation
RVG 100101
MA holder
ACCORD HEALTHCARE B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Carboplatin Accord 10 mg/ml concentraat voor oplossing voor infusie

PRD2005417 · Product

Active substance
Carboplatin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
120 mg/m2 milligram(s)/square meter
Max total dose
480 mg/m2 milligram(s)/square meter
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
L01XA02 — CARBOPLATIN
Marketing authorisation
RVG 100101
MA holder
ACCORD HEALTHCARE B.V.
MA country
Netherlands
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitair Ziekenhuis Gent

21 Total trials 11 Recruiting 6 Ended
Academic / Non-commercial
Sponsor organisation
Universitair Ziekenhuis Gent
Address
Corneel Heymanslaan 10
City
Gent
Postcode
9000
Country
Belgium

Scientific contact point

Organisation
Universitair Ziekenhuis Gent
Contact name
Prof. Dr. Karim Vermaelen

Public contact point

Organisation
Universitair Ziekenhuis Gent
Contact name
Prof. Dr. Karim Vermaelen

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Authorised, recruitment pending 64 1
Rest of world — 0 —

Investigational sites

Belgium

1 site · Authorised, recruitment pending
Universitair Ziekenhuis Gent
Department of Respiratory Medicine, Corneel Heymanslaan 10, 9000, Gent

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 22 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol_2025-521577-13-00_for publication 1.1
Protocol (for publication) D3_Patient facing documents_ EORTC QLQ 29 and 30 Dutch_for publication 1.0
Protocol (for publication) D3_Patient facing documents_ EORTC QLQ 29 and 30 French_for publication 1.0
Protocol (for publication) D4_Patient facing documents_Subject card Dutch_for publication 1.0
Protocol (for publication) D4_Patient facing documents_Subject card French_for publication 1.0
Recruitment arrangements (for publication) K2_Recruitment material_information website_for publication 1.0
Recruitment arrangements (for publication) K3_Recruitment and informed consent procedure_for publication 1.0
Subject information and informed consent form (for publication) K3_Recruitment and informed consent procedure_for publication 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF Sponsor statement_for publication 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_FR_for publication 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_FR_track changes 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_NL_for publication 1.2
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Carboplatin NL 1.0
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Cisplatin NL 1.0
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Keytruda NL 1.0
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Libtayo NL 1.0
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Paclitaxel NL 1.0
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Pemetrexed accord NL 1.0
Synopsis of the protocol (for publication) D1_Protocol Synopsis_Dutch_2025-521577-13-00_for publication 1.0
Synopsis of the protocol (for publication) D1_Protocol Synopsis_ENG_2025-521577-13-00_for publication 1.0
Synopsis of the protocol (for publication) D1_Protocol Synopsis_French_2025-521577-13-00_for publication 1.0
Synopsis of the protocol (for publication) D1_Protocol Synopsis_German_2025-521577-13-00_for publication 1.0

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-06-24 Belgium Acceptable
2025-08-25
 2025-08-25
2 NON SUBSTANTIAL MODIFICATION NSM-1 2025-09-11 Belgium Acceptable
2025-08-25
 2025-09-11

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