Clinical Trials Register

Summary
EudraCT Number:	2020-005602-26
Sponsor's Protocol Code Number:	FL-101-2001
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2021-06-22
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Netherlands - Competent Authority

A.2

EudraCT number

2020-005602-26

A.3

Full title of the trial

A Two-cohort, Phase 2 Study of FL-101 as Neoadjuvant Therapy in Patients with Surgically Resectable Non-Small Cell Lung Cancer

Een Twee-cohorten, Fase 2 Onderzoek naar FL-101 als neoadjuvante behandeling bij patiënten met chirurgisch reseceerbare niet-kleincellige longkanker

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Phase 2 study of FL-101 in non-small cell lung cancer

Fase 2 studie naar FL-101 in niet-kleincellige longkanker

A.3.2

Name or abbreviated title of the trial where available

Phase 2 Study of FL-101 in NSCLC

Fase 2 studie naar FL-101 in NSCLC

A.4.1

Sponsor's protocol code number

FL-101-2001

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Flame Biosciences
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Flame Biosciences
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Flame Biosciences
B.5.2	Functional name of contact point	Clinical Trial Information
B.5.3	Address:
B.5.3.1	Street Address	280 Union Square Drive
B.5.3.2	Town/ city	New Hope
B.5.3.3	Post code	18938
B.5.3.4	Country	United States
B.5.6	E-mail	clinicaltrials@flame.bio

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.2	Product code	FL-101
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Anti-IL-1β antibody, subclass IgG4
D.3.9.2	Current sponsor code	FL-101
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Opdivo
D.2.1.1.2	Name of the Marketing Authorisation holder	Bristol-Myers Squibb Pharma EEIG
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Nivolumab (Opdivo)
D.3.9.2	Current sponsor code	N/A
D.3.9.3	Other descriptive name	NIVOLUMAB
D.3.9.4	EV Substance Code	SUB122750
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	240
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Surgically resectable non-small cell lung cancer

E.1.1.1

Medical condition in easily understood language

Non-small cell lung cancer

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)

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	10029517
E.1.2	Term	Non-small cell lung cancer stage I
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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	10029518
E.1.2	Term	Non-small cell lung cancer stage II
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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	10029520
E.1.2	Term	Non-small cell lung cancer stage IIIA
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the safety and tolerability of FL-101 as monotherapy and in combination with nivolumab

E.2.2

Secondary objectives of the trial

Efficacy
Cohort 1: To evaluate the activity of FL-101 neoadjuvant monotherapy in patients with Stage IA3 or IB NSCLC
Cohort 2: To evaluate the effect of FL-101 in combination with nivolumab compared to nivolumab plus placebo in neoadjuvant therapy in patients with Stage II-IIIA NSCLC
To determine major pathologic response (MPR) rate
To determine complete pathologic response (CPR) rate
To estimate objective response rate (ORR) by RECIST 1.1 following neoadjuvant FL-101
To describe the time course of MRD response by ctDNA and recurrence in correlation with clinical response

Pharmacologic (PK/ PD)
To evaluate the PK of FL-101 in patients with NSCLC.
To evaluate the effect of FL-101 on PD biomarkers.

Safety
To evaluate possible immunogenicity, anti-drug antibodies

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

The Netherlands will only participate in Cohort 1 of the study

E.3

Principal inclusion criteria

Patients are eligible to be included in the study only if ALL the following criteria apply:
1. Male and female patients ≥18 years of age.
2. Previously untreated and pathologically confirmed, surgically resectable Stage IA3, IB, II, or IIIA NSCLC of squamous or non-squamous histology. Staging is based on the eighth edition of the AJCC/UICC staging system.
3. ≥1 radiologically measurable tumor >2 cm in diameter, as defined by RECIST v1.1 (Eisenhauer 2009).
4. Lung function capacity capable of tolerating the proposed lung surgery.
5. Smoking history ≥10 pack years.
6. High-sensitivity C-reactive protein (hsCRP) level ≥2 mg/L
7. Adequate organ function as defined by ALL of the following:
- Absolute neutrophil count (ANC) ≥1500/μL
- Platelets ≥100,000 /μL
- Hemoglobin ≥9 g/dL
- AST/ALT ≤2.5× upper limit of normal (ULN)
- Total serum bilirubin ≤1.5×ULN; patients with Gilbert’s disease: ≤3×ULN
- Alkaline phosphatase ≤2.5×ULN
- INR and aPTT ≤1.5×ULN unless the patient is on therapeutic anticoagulation
- Serum creatinine ≤1.5×ULN
OR
Creatinine clearance ≥30 mL/min/1.73 m2 by Cockcroft-Gault estimation. The patient’s estimated CrCl will be calculated by the local laboratory (for eligibility purposes) using screening/baseline height (m), actual weight (kg), and serum creatinine:
Males: CrCl = ((140 – age in years) × weight (kg))/72× serum creatinine (mg/dL)
Females: CrCl = ((140 – age in years) × weight (kg) ×0.85)/72× serum creatinine (mg/dL)
8. Available tissue block for analysis from a core needle biopsy (or similar sample).
-Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks are preferred) or at least 10 unstained slides, with an associated pathology report, for central testing.
-Acceptable samples include core-needle biopsies for deep tumor tissue (minimum of 3 cores) or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions.
9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix 2).
10. Men must agree to use contraception or practice abstinence as well as refrain from donating sperm during the treatment period and for ≥180 days after the last dose of study treatment. (Section 5.3).
11. Women may participate if not pregnant, not breastfeeding, and at least 1 of the following conditions apply:
- Not a woman of childbearing potential (WOCBP)
- WOCBP who agrees to follow contraceptive guidance (Section 5.3) during the treatment period and for at least 180 days after the last dose of study treatment.

Female patients will be considered of non-reproductive potential (not a WOCBP) if they are either:
(1) postmenopausal (defined as at least 12 months with no menses without an alternative medical cause. In women < 45 years of age, a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
OR
(2) have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 6 weeks prior to screening
OR
(3) have a congenital or acquired condition that prevents childbearing.
12. Able and willing to comply with protocol-specified requirements and to provide written informed consent.

E.4

Principal exclusion criteria

1. Any prior exposure to chemotherapy, radiotherapy, or systemic anti-cancer therapy for lung cancer
2. Malignancies other than NSCLC within 2 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai Stage 0, prostate cancer with Gleason score ≤6, and prostate specific antigen [PSA] ≤10 mg/mL, etc.)
3. Currently participating in, or has participated in, a trial of an investigational agent within 4 weeks prior to the first dose of trial treatment or 5 half-lives, whichever is longer, or without recovery of clinically significant toxicities from that therapy.
4. Any of the following tumor locations/types: a. NSCLC involving the superior sulcus. b. Large cell neuro-endocrine cancer. c. Sarcomatoid tumor.
5. Tumors known to express driver mutations of EGFR or ALK pathways. Patients whose driver mutation status is unknown may enroll in the study; tissue will be checked after enrollment. SAP will describe how patients found to have one of the 2 driver mutations will be handled.
6. History of non-infectious pneumonitis /interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease that requires steroids.
7. Had allogenic tissue/sold organ transplant.
8. Known severe hypersensitivity (Grade ≥3) to FL-101, its active substance, or any of its excipients.
9. Known history of human immunodeficiency virus (HIV) or active Hepatitis B or Hepatitis C infection.
10. Received radiotherapy within 2 weeks of start of study treatment.
11. Symptomatic herpes zoster within the past 30 days, a serious bacterial infection within the past 6 months or have had other recent or ongoing signs of infections
12. Received a live or attenuated vaccine within 30 days prior to the first dose of study treatment.
13. Clinically unstable disease in any organ system despite current therapy, including, but not limited to ongoing or active infection including tuberculosis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations.
14. Use of illicit drugs or excess intake of alcohol, based on the judgement of the investigator.

Additional Criteria for Patients with Stage II and III Disease
1. Prior treatment with anti-PD-1, anti-CTLA-4, or anti-PD-L1 therapeutic antibody or pathway-targeting agents
2. Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to Cycle 1, Day 1.
- Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a 1-time dose of dexamethasone for nausea) may be enrolled.
- The use of inhaled corticosteroids for asthma / COPD and mineralocorticoids (e.g., fludrocortisone) for orthostatic hypotension or adrenocortical insufficiency is allowed.
3. Known severe hypersensitivity (Grade ≥3) to nivolumab or any of the study chemotherapy agents or to any of their excipients.
4. Active autoimmune disease that has required systemic treatment in past 2 years. History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Bell’s palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, uveitis, or glomerulonephritis.
- Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible.
- Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen are eligible.
- Patients with eczema, psoriasis, lichen simplex chronicus or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted if they meet the following conditions:
a. Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations. b. Rash must cover <10% of body surface area (BSA). c. Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%). d. No acute exacerbations of an underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)

E.5 End points

E.5.1

Primary end point(s)

To evaluate the tolerability, incidence and severity of AEs and SAEs graded according to NCI CTCAE v5.0 of FL-101 as monotherapy and in combination with nivolumab.

E.5.1.1

Timepoint(s) of evaluation of this end point

From time of first dose to 3 months after surgery.

E.5.2

Secondary end point(s)

Efficacy:
Number of patients with treatment efficacy as assessed by pathological response (percentage of residual tumor) by independent pathology review

Pharmacologic (PK/ PD):
Estimates of the following FL-101 PK parameters: Cmax, Cmin, AUC0-t, AUC0-inf, CL, Vz, t½
Change from baseline in serum hsCRP, IL-6, and neutrophil / lymphocyte ratio.
Change from baseline in plasma IL-1β levels

Safety:
Prevalence and incidence of anti-FL-101 antibodies.

E.5.2.1

Timepoint(s) of evaluation of this end point

At time of surgery (around 6-8 weeks after first dose)

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Cohort 1 is single-arm, open-label. Cohort 2 is 2-arm, randomised and double-blind (NA for NLD)

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

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

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Canada

United States

France

Netherlands

E.8.7

Trial has a data monitoring committee

Yes

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

End of study is defined as the date of the last follow-up for patient safety.

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

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Patients will be followed for 3 months following surgery.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2021-11-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-11-15

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2021-11-23

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