E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non-Small Cell Lung Cancer |
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E.1.1.1 | Medical condition in easily understood language |
Non-Small Cell Lung Cancer |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061873 |
E.1.2 | Term | Non-small cell lung cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- To evaluate FG001 for the detection of NSCLC |
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E.2.2 | Secondary objectives of the trial |
- To evaluate the pharmacokinetics profile of single dose FG001 - To evaluate safety and tolerability
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients are eligible to enter into this trial only if they meet all of the following criteria: 1. Biopsy-verified NSCLC (adenocarcinoma or squamous-cell carcinoma) and scheduled for surgery (VATS). Note that biopsy-verified NSCLC refers to the biopsy upon which the patient was diagnosed with NSCLC 2. Peripheral location of the tumor (based on CT/MRI/PET scan no later than 8 weeks old from screening date or a scan must be taken at baseline visit) 3. Tumor size ≥ 1.5 cm 4. No suspicion of metastatic disease 5. Patients aged 18 years or older 6. Capable of understanding and giving written informed consent 7. Patient must not previously have received the trial drug (FG001) 8. Male patients must commit to use barrier contraception (e.g., condom) during the trial and for 30 days after the end-of-trial visit and avoid sperm donation during this period 9. Women of childbearing potential must agree to use an adequate method of contraception during the trial and for 30 days after the end-of-trial visit. Adequate methods of contraception include intrauterine device or hormonal contraception (oral contraceptive pill, depot injections or implant, transdermal depot patch or vaginal ring). To be considered sterilised or infertile, females must have undergone surgical sterilisation (bilateral tubectomy, hysterectomy or bilateral ovariectomy) or be post-menopausal (defined as at least 12 months amenorrhoea; may be confirmed with follicle-stimulating hormone [FSH] test if there is doubt)
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E.4 | Principal exclusion criteria |
Patients are eligible to enter into this trial only if they do NOT meet any of the following criteria: 1. Any known allergy or hypersensitivity to indocyanine green (ICG) or any other component of the drug product 2. Female patients who are pregnant or breast-feeding (pregnancy test positive prior to inclusion) 3. Overall performance status or co-morbidity deeming the patient unfitted for participation in the trial as judged by the Investigator 4. Pre-existing hepatic and/or renal insufficiency - INR > 1,7 - Estimated GFR (eGFR) >45 ml/min/1,73m2 5. Unwilling or unable to follow the protocol requirements
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E.5 End points |
E.5.1 | Primary end point(s) |
- Sensitivity for detection of NSCLC |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The efficacy of FG001 (as a tumor imaging agent) is examined by the sensitivity, which is verified via the intensity of fluorescence from the biopsies. TBR will be calculated as the fluorescence of the tumor relative to background tissue, as measured by near-infrared (NIR) imaging. This is imaged in situ during resection. |
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E.5.2 | Secondary end point(s) |
a. Efficacy For cohort 1:
PK profile determined by non-compartmental analysis: - Peak plasma concentration (Cmax) - Time of peak plasme concentration (tmax) - Area under the plasma concentration-time curve from time-zero extrapolated to infinity (AUC0-inf) - Area under the plasma concentration-time curve from time-zero to last quantifiable concentration (AUC0-t) - Terminal half-life (t½)
For cohort 2 and onwards: - Demonstrate exposure of FG001 after 1 hour and prior to surgery
b. Safety and tolerability - Adverse Events - Laboratory parameters - 12 - lead ECG parameters - Vital Signs
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
For cohort 1: Samples will be used to evaluate the PKs of FG001 and will be taken at the following timepoints from the administration of FG001: +1 Hour (± 15 mins), +13 hours (±2 hours), +24 hours (± 4 hours), +36 hours (± 4 hours), and +44 hours (± 6 hours). Safety and tolerability will be evaluated throughout the trial.
For cohort 2 and onwards: Samples will be used to evaluate the PKs of FG001 and will be drawn at the following timepoints from administration of FG001: Day 1 (+1 hour (± 15 mins), and Day 3 in the morning prior to surgery (between 7 and 9 am). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The completion of the entire trial (the end of the trial), will be the date of the last visit of the last patient undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |