FG001 in patients with non-small cell lung cancer

Phase 1

• Conditions: on-Small Cell Lung Cancer; MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-004389-37-DK
• Lead Sponsor: FluoGuide A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-22
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 44

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)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified