Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruiting
Participants planned
225
Countries
6
Sites
42
Metastatic Non-Small-Cell Lung Cancer
To evaluate the efficacy of LN-145 measured by objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 assessed by the Independent Review Committee (IRC) for Cohorts 1 and 2 and by the Investigator for Cohorts 3 and 4 and the Retreatment Cohort
Key facts
- Sponsor
- Iovance Biotherapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 19 Dec 2025 → ongoing
- Decision date (initial)
- 2025-05-20
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Iovance Biotherapeutics Inc.
External identifiers
- EU CT number
- 2024-510778-26-00
- EudraCT number
- 2020-003629-45
- ClinicalTrials.gov
- NCT04614103
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy, Safety
To evaluate the efficacy of LN-145 measured by objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 assessed by the Independent Review Committee (IRC) for Cohorts 1 and 2 and by the Investigator for Cohorts 3 and 4 and the Retreatment Cohort
Secondary objectives 1
- • To evaluate the efficacy of LN-145 measured by ORR using RECIST v1.1 assessed by the Investigator for Cohorts 1 and 2 • To further evaluate the efficacy of LN-145 measured by complete response (CR) rate, duration of response (DOR), disease control rate (DCR), andprogression-free survival (PFS) using RECIST v1.1 assessed by the IRC (Cohorts 1 and 2) and the Investigator (allcohorts); and overall survival(OS) • To characterize the safety profile of LN-145 in patients with non-smallcell lung cancer (NSCLC) measured by the incidence of Grade ≥3 treatment emergent adverse events (TEAEs) • Cohort 3 only: To determine the feasibility of LN-145 production using tumor tissue obtained via image-guided core biopsy of tumor
Conditions and MedDRA coding
Metastatic Non-Small-Cell Lung Cancer
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2016-003447-11 | A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety Using Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Recurrent, Metastatic or Persistent Cervical Carcinoma, Estudio fase II, multicéntrico para evaluar la eficacia y la seguridad del uso de Linfocitos Autólogos Infiltrantes Tumorales (LN-145) en pacientes con Carcinoma de Cérvix recidivante, metastásico o persistente, Studio multicentrico di fase 2 per la valutazione dell’efficacia e della sicurezza mediante l’utilizzo di linfociti autologhi infiltranti il tumore (LN-145) in pazienti affette da carcinoma della cervice ricorrente, metastatico o persistente | |
| 2018-001608-12 | A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-144 or LN-145) in Patients with Solid Tumors, Étude de phase II, multicentrique évaluant l'utilisation de lymphocytes autologues infiltrant la tumeur (LN 144 ou LN-145) chez des patients atteints de tumeurs solides, Estudio en fase 2, multicéntrico, de linfocitos infiltrantes de tumores autólogos (LN-144 o LN-145) en pacientes con tumores sólidos. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 14
- 1. Provide written informed consent and written authorization for use and disclosure of protected health information.
- 2. Be 18 to 70 years of age at the time of signing of informed consent form. Patients who are >70 years of age may be allowed to enroll after discussion with the Medical Monitor and with consideration of factors including but not limited to performance status, life expectancy, and frailty of the patient.
- 3. Have histologically or pathologically confirmed diagnosis of metastatic Stage IV NSCLC (squamous, nonsquamous, adenocarcinoma, large cell,or mixed histologies) without EGFR, ALK, or ROSI genomic alterations.
- 4. Meet prior therapy criteria: -post-progression tumor harvest: Patient must have documented radiographic disease progression on or after the first-line therapy, inclusive of prior ICI and platinum-based chemotherapy ± bevacizumab or health authority approved targeted therapy. -pre-progression tumor harvest and TIL production: Patient must have residual resectable disease after completion of the platinum-based chemotherapy component of either concurrent or sequential ICI and platinum-based chemotherapy, meet all eligibility criteria except documented disease progression, and intend to receive TIL therapy after disease progression on current therapy
- 5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of >6 months, in the Investigator's opinion.
- 6. Cohorts 1, 2 and 4: Have at least 1 resectable lesion (or aggregate lesions) with an expected minimum 1.5 cm short axis diameter for TIL production. Cohort 3: Have a single, measurable lesion (RECIST v1.1) and/or are unable to undergo a surgical tumor resection, but able to undergo tumor harvest for TIL generation via image-guided core biopsy. Retreatment Cohort: Meet any tumor requirement listed above. All Cohorts: If the lesion considered for harvest is within a previously irradiated field, the lesion must have demonstratedradiographic progression prior to harvest, and the irradiation must have been completed at least 3 months prior to enrollment. Patients must have an adequate histopathology specimen for protocol-required testing.
- 7. Have at least 1 remaining measurable lesion as defined by RECIST v1.1 following tumor harvest for TIL manufacturing that is documented at Screening
- 8. Required hematologic parameters: •Absolute neutrophil count ≥1000/mm3. •Hemoglobin ≥8.0 g/dL. •Platelet count ≥100,000/mm3
- 9. Have adequate organ function with the following laboratory test values: •ALT and AST ≤3times the upper limit of normal (≤3 × ULN); for patients with liver metastases ≤5 × ULN. •Total bilirubin ≤2 mg/dL; patients with Gilbert's Syndrome ≤3mg/dL. •Estimated creatinine clearance ≥40 mL/min using the Cockcroft-Gault formula at Screening
- 10. Have a left ventricular ejection fraction (LVEF) >45% and be New York Heart Association (NYHA) Class 1.
- 11. Have adequate pulmonary function. All patients must perform a 6-minute walk test and must be able to walk a distance of at least 80% of predicted for age and sex with no evidence of hypoxia (ie, saturation of peripheral oxygen [SpO2] must remain ≥90% on room air).
- 12. Have completed/discontinued chemotherapy ≥21 days prior to tumor harvest.
- 13. Must have recovered from all prior anticancer treatment-related adverse events to Grade≤1 (per CTCAE v5.0). Patients with irreversible toxicity (eg, alopecia, vitiligo) after prior anticancer therapies that are not considered by the Investigator to be a likely safety risk may qualify for the study after discussion with the Medical Monitor
- 14. Patients of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method ofhighly effective birth control during treatment and for 12 months after receiving all protocol-related therapy.
Exclusion criteria 13
- 1.Have a history of allogeneic organ transplant or any form of cell therapy involving a prior nonmyeloablative or myeloablative chemotherapy regimen within the past 20 years. Patients being retreated with LN-145 are not excluded due to prior NMA-LD during this study.
- 2.Have known actionable EGFR, ALK, or ROSI driver mutations.
- 3.Have symptomatic untreated brain metastasis. Patients with brain metastases may be enrolled with the following considerations and only after discussion with the Medical Monitor:
- 4.Require systemic steroid therapy >10 mg/day prednisone or equivalent. Patients receiving steroids as replacement therapy for adrenocortical insufficiency at ≤10 mg/day prednisone or equivalent are not excluded.
- 5.Have evidence of any active viral, bacterial, or fungal infection requiring ongoing systemic treatment or as per required screening tests 6.Are pregnant or breastfeeding. Female patients of childbearing potential must have a negative beta-human chorionic gonadotropin (βHCG) test with minimum sensitivity of 25 IU/L β-HCG (or equivalent) at Screening.
- 6.Are pregnant or breastfeeding. Female patients of childbearing potential must have a negative beta-human chorionic gonadotropin (βHCG) test with minimum sensitivity of 25 IU/L β-HCG (or equivalent) at Screening.
- 7.Have an active medical illness(es) that in the opinion of the Investigator would pose increased risks for study participation, such as systemic infections, coagulation disorders, or other active major medical illnesses of the cardiovascular, respiratory, or immune systems.
- 8.Have received a live or attenuated vaccination within 28 days prior to the start of NMA-LD.
- 9.Have any form of primary immunodeficiency (eg, severe combined immunodeficiency disease [SCID] or acquired immune deficiency syndrome [AIDS]).
- 10.Have a history of hypersensitivity to any component of the study drugs. LN-145 should not be administered to patients with a known hypersensitivity to any component of the autologous TIL product formulation, including, but not limited to, any of the following: •NMA-LD (cyclophosphamide, mesna, and fludarabine) •Proleukin®, aldesleukin, IL-2 •Antibiotics of the aminoglycoside group (ie, streptomycin, gentamicin). These patients may be eligible if current hypersensitivity has been excluded. •Any component of the TIL product formulation, including dimethyl sulfoxide (DMSO), human serum albumin (HSA), IL-2, or dextran-40
- 11.Have had another primary malignancy within the previous 3 years (except for malignancies that do not require treatment or have been curatively treated >1 year ago, and in the judgment of the Investigator do not pose a significant risk of recurrence including, but not limited to: in situ carcinoma of the cervix; early stage skin cancer, including nonmelanoma skin cancer; ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) of the breast; prostate cancer with Gleason score ≤6; or superficial bladder cancer).
- 12.Participated in another clinical study with an investigational product within 21 days prior to enrollment with the exception of investigational programmed cell death-1 (PD-1)/PD-L1 inhibitors or tyrosine kinase inhibitors (TKIs), which may be continued until 7 days prior to initiation of NMA-LD
- 13.Have any condition or characteristic (eg, known psychiatric diagnosis/symptoms, alcohol abuse, or substance abuse) that, in the opinion of the Investigator, could interfere with the evaluation or interpretation of study treatment, patient safety, or study results
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- ORR is defined as the proportion of patients who have a confirmed CR or PR as assessed per RECIST v1.1 by the IRC (Cohorts 1 and 2) or by the Investigator (Cohorts 3, 4 and Retreatment Cohort) from the date of LN145 infusion until disease progression or start of a new anticancer therapy.
Secondary endpoints 5
- •ORR (Cohorts 1 and 2), CR rate, DOR, DCR, and PFS (all cohorts) as assessed by the Investigator per RECIST v1.1
- • CR rate, DOR, DCR, and PFS as assessed by IRC per RECIST v1.1 (Cohorts 1 and 2)
- • Overall survival (OS)
- • Incidence of Grade ≥3 TEAEs and SAEs per CTCAE v5.0 in all patients
- • Percentage of successful LN-145 product generated from core biopsies in Cohort 3
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10381998 · Product
- Active substance
- Autologous Tumour-Infiltrating Lymphocytes
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 100000000000 DF dosage form
- Max total dose
- 100000000000 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- IOVANCE BIOTHERAPEUTICS, INC.
- Paediatric formulation
- No
- Orphan designation
- No
Auxiliary 16
Fludarabinefosfaat – PCH 25 mg/ml, concentraat voor oplossing voor injectie/infusie
PRD732137 · Product
- Active substance
- Fludarabine Phosphate
- Substance synonyms
- FLUDARABINE 5'-MONOPHOSPHATE, FLUDARABINE MONOPHOSPHATE
- Pharmaceutical form
- INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 25 mg/m2 milligram(s)/sq. meter
- Max total dose
- 125 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BB05 — FLUDARABINE
- Marketing authorisation
- RVG 33255
- MA holder
- PHARMACHEMIE BV
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and study specific labeling. Labeling includes patient information, study information, sponsor information, as well as storage and safety warnings.
SUB07678MIG · Substance
- Active substance
- Fludarabine
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 25 mg/m2 milligram(s)/sq. meter
- Max total dose
- 125 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and study specific labeling. Labeling includes patient information, study information, sponsor information, as well as storage and safety warnings.
Флударабин Актавис 25 mg/ml концентрат за инжекционен или инфузионен разтвор
PRD930525 · Product
- Active substance
- Fludarabine Phosphate
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 50 ml millilitre(s)
- Max total dose
- 125 ml millilitre(s)
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BB05 — FLUDARABINE
- Marketing authorisation
- 20100674
- MA holder
- TEVA PHARMA EAD
- MA country
- Bulgaria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and study specific labeling. Labeling includes patient information, study information, sponsor information, as well as storage and safety warnings.
Fludarabine Accord 25 mg/ml koncentratas injekciniam ar infuziniam tirpalui
PRD1794902 · Product
- Active substance
- Fludarabine Phosphate
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 25 mg/m2 milligram(s)/sq. meter
- Max total dose
- 125 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BB05 — FLUDARABINE
- Marketing authorisation
- LT/1/14/3627/001
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Lithuania
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and study specific labeling. Labeling includes patient information, study information, sponsor information, as well as storage and safety warnings.
Fludarabine Phosphate 25 mg/ml Concentrate for Solution for Injection or Infusion
PRD786717 · Product
- Active substance
- Fludarabine Phosphate
- Substance synonyms
- FLUDARABINE 5'-MONOPHOSPHATE, FLUDARABINE MONOPHOSPHATE
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 25 mg/m2 milligram(s)/sq. meter
- Max total dose
- 125 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BB05 — FLUDARABINE
- Marketing authorisation
- PL 00289/0938
- MA holder
- TEVA UK LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fludarabina Teva 25 mg/ml concentrado para solución para perfusión o inyección EFG
PRD664775 · Product
- Active substance
- Fludarabine Phosphate
- Pharmaceutical form
- INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 25 mg/m2 milligram(s)/sq. meter
- Max total dose
- 125 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BB05 — FLUDARABINE
- Marketing authorisation
- 69052
- MA holder
- TEVA PHARMA S.L.U.,
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and study specific labeling. Labeling includes patient information, study information, sponsor information, as well as storage and safety warnings.
Fludarabine phosphate 25 mg/ml Concentrate for Solution for Injection or Infusion
PRD1794909 · Product
- Active substance
- Fludarabine Phosphate
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 25 mg/m2 milligram(s)/sq. meter
- Max total dose
- 125 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BB05 — FLUDARABINE
- Marketing authorisation
- PL 20075/0379
- MA holder
- ACCORD HEALTHCARE LIMITED
- MA country
- United Kingdom
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and study specific labeling. Labeling includes patient information, study information, sponsor information, as well as storage and safety warnings.
Fludarabine 50mg Powder For Solution For Injection Or Infusion
PRD7156994 · Product
- Active substance
- Fludarabine Phosphate
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 50 ml millilitre(s)
- Max total dose
- 125 ml millilitre(s)
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BB05 — FLUDARABINE
- Marketing authorisation
- PL 0142/1013
- MA holder
- ACTAVIS UK LIMITED
- MA country
- United Kingdom
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and study specific labeling. Labeling includes patient information, study information, sponsor information, as well as storage and safety warnings.
Fludarabine Teva 25 mg/ml solution à diluer pour injection ou perfusion
PRD3852415 · Product
- Active substance
- Fludarabine Phosphate
- Substance synonyms
- FLUDARABINE 5'-MONOPHOSPHATE, FLUDARABINE MONOPHOSPHATE
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 25 mg/m2 milligram(s)/sq. meter
- Max total dose
- 125 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BB05 — FLUDARABINE
- Marketing authorisation
- BE303721
- MA holder
- TEVA PHARMA BELGIUM N.V./S.A
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PROLEUKIN® 18 x 106 IU Powder for solution for injection or infusion
PRD11346174 · Product
- Active substance
- Aldesleukin
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 600000 IU/kg international unit(s)/kilogram
- Max total dose
- 3600000 IU/kg international unit(s)/kilogram
- Max treatment duration
- 4 Day(s)
- Authorisation status
- Authorised
- ATC code
- L03AC01 — ALDESLEUKIN
- Marketing authorisation
- PL 59077/0001
- MA holder
- IOVANCE BIOTHERAPEUTICS B.V
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Proleukin 18 x 106 IE Poeder voor oplossing voor injectie of infusie
PRD11294442 · Product
- Active substance
- Aldesleukin
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 600000 IU/Kg iu/kilogram
- Max total dose
- 3600000 IU/Kg iu/kilogram
- Max treatment duration
- 4 Day(s)
- Authorisation status
- Authorised
- ATC code
- L03AC01 — ALDESLEUKIN
- Marketing authorisation
- RVG 13354
- MA holder
- IOVANCE BIOTHERAPEUTICS B.V
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Proleukin 18 x 106 IE Poeder voor oplossing voor injectie of infusie
PRD7353031 · Product
- Active substance
- Aldesleukin
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 600000 IU/Kg iu/kilogram
- Max total dose
- 3600000 IU/Kg iu/kilogram
- Max treatment duration
- 4 Day(s)
- Authorisation status
- Authorised
- ATC code
- L03AC01 — ALDESLEUKIN
- Marketing authorisation
- RVG 13354
- MA holder
- CLINIGEN HEALTHCARE B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and study specific labeling. Labeling includes patient information, study information, sponsor information, as well as storage and safety warnings.
Endoxan 1000 mg milteliai injekciniam tirpalui
PRD349512 · Product
- Active substance
- Cyclophosphamide Monohydrate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 60 mg/kg milligram(s)/kilogram
- Max total dose
- 120 mg/kg milligram(s)/kilogram
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01AA01 — CYCLOPHOSPHAMIDE
- Marketing authorisation
- LT/1/97/3087/004
- MA holder
- UAB “BAXTER LITHUANIA”
- MA country
- Lithuania
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cyclophosphamide 1000 mg Powder for Solution for Injection or Infusion
PRD1649381 · Product
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 60 mg/kg milligram(s)/kilogram
- Max total dose
- 120 mg/kg milligram(s)/kilogram
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01AA01 — CYCLOPHOSPHAMIDE
- Marketing authorisation
- PL 04416/1394
- MA holder
- SANDOZ LTD
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD11980406 · Product
- Active substance
- Cyclophosphamide Monohydrate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 60 mg/kg milligram(s)/kilogram
- Max total dose
- 120 mg/kg milligram(s)/kilogram
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01AA01 — CYCLOPHOSPHAMIDE
- Marketing authorisation
- 6035903.00.00
- MA holder
- BAXTER DEUTSCHLAND GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cyclophosphamide Injection 1 g.
PRD347230 · Product
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 60 mg/Kg milligram(s)/kilogram
- Max total dose
- 60 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01AA01 — CYCLOPHOSPHAMIDE
- Marketing authorisation
- PL 00116/0388
- MA holder
- BAXTER HEALTHCARE LTD.
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary packaging and study specific labeling. Labeling includes patient information, study information, sponsor information, as well as storage and safety warnings.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Iovance Biotherapeutics Inc.
- Sponsor organisation
- Iovance Biotherapeutics Inc.
- Address
- 825 Industrial Road Fl 4
- City
- San Carlos
- Postcode
- 94070-3312
- Country
- United States
Scientific contact point
- Organisation
- Iovance Biotherapeutics Inc.
- Contact name
- Guy Ruble
Public contact point
- Organisation
- Iovance Biotherapeutics Inc.
- Contact name
- Iovance
Third parties 6
| Organisation | City, country | Duties |
|---|---|---|
| Mlm Medical Labs GmbH ORG-100043721
|
Mönchengladbach, Germany | Laboratory analysis |
| Theradex (Europe) Limited ORG-100008668
|
Crawley, United Kingdom | Data management, E-data capture |
| PPD Development LP ORG-100011560
|
Wilmington, United States | On site monitoring, Code 12, Other, Code 5 |
| Perceptive Informatics Inc. ORG-100013171
|
Billerica, United States | Other |
| Scout Clinical ORG-100042228
|
Dallas, United States | Other |
| Syneos Health UK Limited ORG-100008519
|
Farnborough, United Kingdom | Code 8 |
Locations
6 EU/EEA countries · 42 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 13 | 3 |
| France | Ongoing, recruiting | 12 | 9 |
| Germany | Ongoing, recruitment ended | 30 | 7 |
| Italy | Ongoing, recruitment ended | 10 | 7 |
| Netherlands | Ongoing, recruitment ended | 30 | 1 |
| Spain | Ongoing, recruitment ended | 20 | 15 |
| Rest of world
United Kingdom, Canada, United States
|
— | 110 | — |
Investigational sites
Centre hospitalier universitaire de Liege
Service d’Oncologie Médicale, Avenue De L'Hopital 1, 4000, Liege
UZ Brussel
Universitair Ziekenhuis Brussel Medische Oncologie, Laarbeeklaan 101, 1090, Jette
Universitair Ziekenhuis Antwerpen
Universitair Ziekenhuis Antwerpen Dienst Oncologie, Drie Eikenstraat 655, 2650, Edegem
University Hospital Of Clermont-Ferrand
Département d’oncologie médicale, 1 Place Lucie Et Raymond Aubrac, 63100, Clermont-Ferrand
Centre Hospitalier Universitaire De Poitiers
Départment d’oncologie médicale Pôle régional de Cancérologie, 2 Rue De La Miletrie, 86000, Poitiers
Institut Paoli Calmettes
N/A, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Hospitalier Universitaire De Nantes
Département d’Oncologie médicale – Unité d’oncologie thoracique, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Centre Hospitalier Universitaire Amiens Picardie
Département d’Oncologie Médicale, 30 Avenue De La Croix Jourdain, 80054, Amiens Cedex 1
Hospices Civils De Lyon
Service de Pneumologie, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
CHRU De Nancy
Département de Pneumologie, Co N°34, 29 Avenue Du Mal De Lattre De Tassigny, Nancy Cedex
Institut Gustave Roussy
Département d’Oncologie Médicalee, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Universitaire De Nice
Département de Pneumologie, Oncologie Thoracique et Soins Intensifs Respiratoires, 10 Rue Moliere, 06100, Nice
Klinikum der Universitaet Muenchen AöR
Med. Klinik V / Thorakale Onkologie, Ziemssenstrasse 1, Ludwigsvorstadt-Isarvorstadt, Munich
Universitaetsklinikum Bonn AöR
Medizinische Klinik und Poliklinik III, Innere Medizin mit den Schwerpunkten Onkologie, Hämatologie, Venusberg-Campus 1, Venusberg, Bonn
Universitat Heidelberg
Abteilung Personalisierte Onkologie mit Schwerpunkt Bronchialkarzinom, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Goethe University Frankfurt
Medizinische Klinik II, Hämatologie/Onkologie, Rheumatologie, Infektiologie, HIV, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Technische Universitaet Dresden
Medizinische Klinik und Poliklinik I / ECTU (Early Clinical Trial Unit), Haus 27, 4. Etage, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Charite Universitaetsmedizin Berlin KöR
ECTU Campus Benjamin Franklin Medizinische Klinik mit dem Schwerpunkt Hämatologie und Onkologie, Hindenburgdamm 30, Lichterfelde, Berlin
University Medical Center Hamburg-Eppendorf
II. med, Klinik Innere Medizin Onkologisches Zentrum, Martinistrasse 52, Eppendorf, Hamburg
Azienda Ospedaliero Universitaria Di Modena
Oncology and Hematology, Largo Del Pozzo 71, 41124, Modena
Ospedale San Raffaele S.r.l.
UOC Oncologia Medica, Via Olgettina 60, 20132, Milan
Fondazione IRCCS Istituto Nazionale Dei Tumori
S.C. Oncologia Medica 1, Via Giacomo Venezian 1, 20133, Milan
Azienda Ospedaliero Universitaria Careggi
SOD Radioterapia Oncologica, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Sanitaria Territoriale Di Pesaro E Urbino
UOC Oncologia, Via Lombroso S/N, 61122, Pesaro
Fondazione IRCCS Policlinico San Matteo
SC Oncologia, Viale Camillo Golgi 19, 27100, Pavia
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Oncology, Strada Provinciale 142 Orba Km 3,95, 10060, Candiolo
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Medical Oncology, Plesmanlaan 121, 1066 CX, Amsterdam
Hospital Universitario Reina Sofia
Servicio de Oncologia medica, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitario 12 De Octubre
Servicio de Oncologia médica, Avenida De Cordoba Sn, 28041, Madrid
Clinica Universidad De Navarra
Servicio de Oncologia, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitario Ramon Y Cajal
Servicio de Oncologia medica, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario La Paz
Servicio de Oncologia médica, Paseo De La Castellana 261, 28046, Madrid
Clinica Universidad De Navarra
Servicio de Oncologia, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitario Regional De Malaga
Servicio de Oncologia medica, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital Universitario De Salamanca
Servicio de Oncologia médica, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Clinico Universitario De Valencia
Servicio de Oncologia médica, Avenida Blasco Ibanez 17, 46010, Valencia
Consorcio Hospital General Universitario De Valencia
Servicio de Oncologia médica, Provincial De Castellon, Avinguda Del Doctor Clara 19, Castello De La Plana
University Hospital Virgen Del Rocio S.L.
Servicio de Oncologia, Avenida De Manuel Siurot S/n, 41013, Sevilla
Complexo Hospitalario Universitario A Coruna
Servicio de Oncologia médica, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Universitario Hm Sanchinarro
Servicio de Oncologia médica, Calle Ona 10, 28050, Madrid
Instituto Oncologico Dr. Rosell S.L.
Servicio de Oncologia medica, Calle De Sabino Arana Num. 5, 08028, Barcelona
Hospital Clinic De Barcelona
Servicio de Oncologia, Calle Villarroel 170, 08036, Barcelona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2025-09-16 | 2026-01-02 | |||
| Germany | 2022-09-02 | 2022-09-05 | 2025-11-11 | ||
| Italy | 2025-07-03 | 2025-10-01 | 2025-11-11 | ||
| Netherlands | 2021-12-08 | 2022-02-01 | 2025-11-11 | ||
| Spain | 2025-07-02 | 2025-08-26 | 2025-11-11 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 5 · Art. 38 CTR
Temporary halt TH-108738
- Halt date
- 2025-11-11
- Planned restart
- 2025-12-19
- Member states concerned
- Spain
- Publication date
- 2025-11-28
- Reason
- Sponsor decision, Medicinal Product related, Study management related
- Explanation
- We are writing to notify you of scheduled routine annual maintenance activities at our iCTC manufacturing facility, which requested investigators to temporarily and briefly pause the identification and screening of new potential clinical trial patients. Importantly, the brief pause in the identification of new potential clinical trial patients is not due to safety or clinical observations in any of our clinical trials and will not impact the integrity of the trials. This notification is being provided should the brief scheduled routine maintenance activities at iCTC and resulting temporary pause in identification of new potential clinical trial patients effectuate any notification or reporting obligations pertaining to this trial.Clinical trials sites were notified of the upcoming temporary pausing of identification of new trial patients on November 11, 2025. Clinical trial participants who were consented and are currently in screening will all complete their screening activities and undergo tumor resection by December 4, 2025. Identification of new clinical trial participants will resume on December 19, 2025. All study procedures are continuing per protocol during the annual maintenance for all participants who have signed informed consents across all of our clinical trials.
Again, this temporary pause for identification of new clinical trial patients is not due to safety or clinical observations in any of our clinical trials and will not impact the integrity of the trials. This pause of identification of new clinical trial patients is solely to perform our routine planned annual maintenance for GMP compliance. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-108746
- Halt date
- 2025-11-11
- Planned restart
- 2025-12-19
- Member states concerned
- Germany
- Publication date
- 2025-11-28
- Reason
- Medicinal Product related, Study management related, Sponsor decision
- Explanation
- We are writing to notify you of scheduled routine annual maintenance activities at our iCTC manufacturing facility, which requested investigators to temporarily and briefly pause the identification and screening of new potential clinical trial patients. Importantly, the brief pause in the identification of new potential clinical trial patients is not due to safety or clinical observations in any of our clinical trials and will not impact the integrity of the trials. This notification is being provided should the brief scheduled routine maintenance activities at iCTC and resulting temporary pause in identification of new potential clinical trial patients effectuate any notification or reporting obligations pertaining to this trial.Clinical trials sites were notified of the upcoming temporary pausing of identification of new trial patients on November 11, 2025. Clinical trial participants who were consented and are currently in screening will all complete their screening activities and undergo tumor resection by December 4, 2025. Identification of new clinical trial participants will resume on December 19, 2025. All study procedures are continuing per protocol during the annual maintenance for all participants who have signed informed consents across all of our clinical trials.
Again, this temporary pause for identification of new clinical trial patients is not due to safety or clinical observations in any of our clinical trials and will not impact the integrity of the trials. This pause of identification of new clinical trial patients is solely to perform our routine planned annual maintenance for GMP compliance. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-108742
- Halt date
- 2025-11-11
- Planned restart
- 2025-12-19
- Member states concerned
- France
- Publication date
- 2025-11-28
- Reason
- Sponsor decision, Medicinal Product related, Study management related
- Explanation
- We are writing to notify you of scheduled routine annual maintenance activities at our iCTC manufacturing facility, which requested investigators to temporarily and briefly pause the identification and screening of new potential clinical trial patients. Importantly, the brief pause in the identification of new potential clinical trial patients is not due to safety or clinical observations in any of our clinical trials and will not impact the integrity of the trials. This notification is being provided should the brief scheduled routine maintenance activities at iCTC and resulting temporary pause in identification of new potential clinical trial patients effectuate any notification or reporting obligations pertaining to this trial.Clinical trials sites were notified of the upcoming temporary pausing of identification of new trial patients on November 11, 2025. Clinical trial participants who were consented and are currently in screening will all complete their screening activities and undergo tumor resection by December 4, 2025. Identification of new clinical trial participants will resume on December 19, 2025. All study procedures are continuing per protocol during the annual maintenance for all participants who have signed informed consents across all of our clinical trials.
Again, this temporary pause for identification of new clinical trial patients is not due to safety or clinical observations in any of our clinical trials and will not impact the integrity of the trials. This pause of identification of new clinical trial patients is solely to perform our routine planned annual maintenance for GMP compliance. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-108743
- Halt date
- 2025-11-11
- Planned restart
- 2025-12-19
- Member states concerned
- Netherlands
- Publication date
- 2025-11-28
- Reason
- Medicinal Product related, Sponsor decision, Study management related
- Explanation
- We are writing to notify you of scheduled routine annual maintenance activities at our iCTC manufacturing facility, which requested investigators to temporarily and briefly pause the identification and screening of new potential clinical trial patients. Importantly, the brief pause in the identification of new potential clinical trial patients is not due to safety or clinical observations in any of our clinical trials and will not impact the integrity of the trials. This notification is being provided should the brief scheduled routine maintenance activities at iCTC and resulting temporary pause in identification of new potential clinical trial patients effectuate any notification or reporting obligations pertaining to this trial.Clinical trials sites were notified of the upcoming temporary pausing of identification of new trial patients on November 11, 2025. Clinical trial participants who were consented and are currently in screening will all complete their screening activities and undergo tumor resection by December 4, 2025. Identification of new clinical trial participants will resume on December 19, 2025. All study procedures are continuing per protocol during the annual maintenance for all participants who have signed informed consents across all of our clinical trials.
Again, this temporary pause for identification of new clinical trial patients is not due to safety or clinical observations in any of our clinical trials and will not impact the integrity of the trials. This pause of identification of new clinical trial patients is solely to perform our routine planned annual maintenance for GMP compliance. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-108740
- Halt date
- 2025-11-11
- Planned restart
- 2025-12-19
- Member states concerned
- Italy
- Publication date
- 2025-11-28
- Reason
- Sponsor decision, Medicinal Product related, Study management related
- Explanation
- We are writing to notify you of scheduled routine annual maintenance activities at our iCTC manufacturing facility, which requested investigators to temporarily and briefly pause the identification and screening of new potential clinical trial patients. Importantly, the brief pause in the identification of new potential clinical trial patients is not due to safety or clinical observations in any of our clinical trials and will not impact the integrity of the trials. This notification is being provided should the brief scheduled routine maintenance activities at iCTC and resulting temporary pause in identification of new potential clinical trial patients effectuate any notification or reporting obligations pertaining to this trial.Clinical trials sites were notified of the upcoming temporary pausing of identification of new trial patients on November 11, 2025. Clinical trial participants who were consented and are currently in screening will all complete their screening activities and undergo tumor resection by December 4, 2025. Identification of new clinical trial participants will resume on December 19, 2025. All study procedures are continuing per protocol during the annual maintenance for all participants who have signed informed consents across all of our clinical trials.
Again, this temporary pause for identification of new clinical trial patients is not due to safety or clinical observations in any of our clinical trials and will not impact the integrity of the trials. This pause of identification of new clinical trial patients is solely to perform our routine planned annual maintenance for GMP compliance. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Unexpected events 1 · Art. 53 CTR
Note: SUSARs are reported via EudraVigilance, not CTIS — events shown here are CTIS-public notifications only.
Unexpected event UE-88797
- Event date
- 2025-06-06
- Date aware
- 2025-06-06
- Submission date
- 2025-07-03
- Member states affected
- Germany, Netherlands, France, Italy, Spain, Belgium
- Clinical procedures
- SOP-0351 Visual inspection of TIL Samples and Using the FACSLyric.
- Event description
- The administration of the product is necessary to avoid an immediate and significant hazard to the patient. Alternative options for the patient have been considered including the potential consequences of not receiving the product. The deviation(s) associated with the lot means that the lot’s specific ability or capacity to achieve the intended therapeutic effect may be impaired.
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 65 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Iovance_IOV-LUN-202_Protocol Clarification Letter_ 2024-510778-26-00_Public | n/a |
| Protocol (for publication) | D1_Iovance_IOV-LUN-202_Protocol Clarification letter_2024-510778-26-00_Public | n/a |
| Protocol (for publication) | D1_Iovance_IOV-LUN-202_Protocol Clarification letter_Public | n/a |
| Protocol (for publication) | D1_Iovance_IOV-LUN-202_Protocol SUSAR Memo_Public | n/a |
| Protocol (for publication) | D1_Iovance_IOV-LUN-202_Protocol_2024-510778-26-00_Public | 6.0 |
| Protocol (for publication) | D4_Iovance_IOV-LUN-202_Patient Questionnaires_BE_DEU_Public | 3.0 |
| Protocol (for publication) | D4_Iovance_IOV-LUN-202_Patient Questionnaires_BE_FRA_Public | 3.0 |
| Protocol (for publication) | D4_Iovance_IOV-LUN-202_Patient Questionnaires_BE_NLD_Public | 3.0 |
| Protocol (for publication) | D4_Iovance_IOV-LUN-202_Patient Questionnaires_DEU_Public | 3.0 |
| Protocol (for publication) | D4_Iovance_IOV-LUN-202_Patient Questionnaires_ENG_Public | 3.0 |
| Protocol (for publication) | D5_Iovance_IOV-LUN-202_Study Restart Letter_Public | n/a |
| Recruitment arrangements (for publication) | K1_IOV-LUN-202_Addendum-Recruitment-Arrangements_DE_Public | n/a |
| Recruitment arrangements (for publication) | K1_IOV-LUN-202_Recruitment Arrangements_BE | 1.0 |
| Recruitment arrangements (for publication) | K1_IOV-LUN-202_Recruitment_Arrangements_FR_French_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_IOV-LUN-202_Recruitment- Arrangements_ES_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_IOV-LUN-202_Recruitment-Arrangements_DE_Public | n/a |
| Recruitment arrangements (for publication) | K1_IOV-LUN-202_Recruitment-Arrangements_IT_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_IOV-LUN-202_Recruitment-Arrangements_NL_Public | n/a |
| Recruitment arrangements (for publication) | K2_IOV-LUN-202_GP_Letter_IT_Italian_Public | 4.0 |
| Recruitment arrangements (for publication) | K2_IOV-LUN-202_Refferal-EMail-Template_DE_German_Public | n/a |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_ Optional-Post-Progression-tumor-Biopsy- ICF_ESP_spa_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_ Optional-Post-Treatment-tumor-Biopsy-ICF_ESP_spa_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_Main ICF_FR_French_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_Main_ICF_DE_German_Public | 9.0 |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_Main_ICF_IT_Italian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_Main-ICF_BE_Dutch_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_Main-ICF_BE_English_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_Main-ICF_BE_French_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_Main-ICF_ES_Spanish_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_OOS_ICF_FR_French_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_OOS_ICF_IT_Italian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_Optional_Biopsies_ICF_DE_German_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_Optional_Genetic_ICF_IT_Italian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_Optional_Sub_Study_ICF_IT_Italian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_Optional-genetic-research-ICF_DE_German_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_optional-Genetic-research-sub-study-ICF_ESP_spa_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_Optional-Post-Progression-Tumor-Tissue-Biopsy-ICF_DE_German_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_Optional-Post-Treatment-Tumor-Tissue-Biopsy-ICF_DE_German_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_Out of Specification-ICF_ES_Spanish_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_Out-of-Specification-ICF_BE_Dutch_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_Out-of-Specification-ICF_BE_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_Out-of-Specification-ICF_BE_French_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_Out-of-Specification-ICF_DE_German_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_Pregnant Partner_ICF_FR_French_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_Pregnant Partner_ICF_IT_Italian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_Pregnant-Partner-and-Newborn-ICF_ES_Spanish_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_Pregnant-Partner-ICF_DE_German_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_Privacy_Addendum_ICF_IT_Italian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_SIS-and-ICF_Adults_NL_Dutch_Public | 9.0 |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_SIS-and-ICF_Pregnancy_NL_Dutch_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_SIS-and-ICF-Genetic_NL_Dutch_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_SIS-and-ICF-Out-Of-Specification_NL_Dutch_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_SIS-and-ICF-Tumor-Tissue-Biopsy_NL_Dutch_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_IOV-LUN-202_Sponsor-Statement-Main-ICF_BE_English | 1.0 |
| Subject information and informed consent form (for publication) | L1_lOV-LUN-202_Pregnant-Partner-ICF_BE_Dutch_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_lOV-LUN-202_Pregnant-Partner-ICF_BE_English_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_lOV-LUN-202_Pregnant-Partner-ICF_BE_French_Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_Iovance_IOV-LUN-202_Protocol Layperson Synopsis_2024-510778-26-00_BE_DEU_Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_Iovance_IOV-LUN-202_Protocol Layperson Synopsis_2024-510778-26-00_BE_FRA_Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_Iovance_IOV-LUN-202_Protocol Layperson Synopsis_2024-510778-26-00_BE_NLD_Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_Iovance_IOV-LUN-202_Protocol Layperson Synopsis_2024-510778-26-00_ENG_Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_Iovance_IOV-LUN-202_Protocol Layperson Synopsis_2024-510778-26-00_ESP_Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_Iovance_IOV-LUN-202_Protocol Layperson Synopsis_2024-510778-26-00_FRA_Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_Iovance_IOV-LUN-202_Protocol Layperson Synopsis_2024-510778-26-00_ITA_Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_Iovance_IOV-LUN-202_Protocol Layperson Synopsis_2024-510778-26-00_NLD_Public | 2.0 |
Application history
15 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-28 | Germany | Acceptable 2024-03-25
|
2024-03-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-04 | Germany | Acceptable 2024-09-09
|
2024-09-09 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-04 | Germany | Acceptable 2024-09-09
|
2024-10-04 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-30 | Germany | Acceptable 2025-02-03
|
2025-02-06 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-02-10 | Acceptable 2025-02-03
|
2025-02-10 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-12 | Germany | Acceptable | 2025-03-24 |
| 7 | SUBSEQUENT ADDITION OF MSC | APP-7 | 2025-03-21 | Acceptable 2025-02-03
|
2025-05-27 | |
| 8 | SUBSEQUENT ADDITION OF MSC | APP-8 | 2025-03-21 | Acceptable 2025-02-03
|
2025-06-13 | |
| 9 | SUBSEQUENT ADDITION OF MSC | APP-9 | 2025-03-21 | 2025-06-12 | ||
| 10 | SUBSEQUENT ADDITION OF MSC | APP-10 | 2025-03-21 | Acceptable 2024-03-25
|
2025-05-20 | |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-07-01 | Germany | Acceptable 2024-03-25
|
2025-07-01 |
| 12 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-07-30 | Germany | Acceptable 2025-11-03
|
2025-11-03 |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-11-26 | Germany | Acceptable 2025-11-03
|
2025-11-26 |
| 14 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-12-10 | Acceptable | 2026-03-09 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-02-27 | Acceptable | 2026-04-07 |