Non-Small Cell Lung CancerPhase 2NCT04758949
FL-101 in Surgically Resectable Non-Small Cell Lung Cancer
A Phase 2 study testing FL-101 and Nivolumab in people with Non-Small Cell Lung Cancer, run by Flame Biosciences.
Trial summary
Phase 2 trial to study FL-101 alone or in combination with nivolumab in patients who have surgically resectable Non-Small Cell Lung Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- FL-101 and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 25 Aug 2021to 22 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously untreated and pathologically confirmed, surgically resectable Stage IA3, IB, II, or IIIA NSCLC of squamous or non-squamous histology.
- ≥1 radiologically measurable tumor >2cm in diameter.
- Smoking history ≥10 pack years.
- Available tissue block for analysis from a core needle biopsy(or similar sample)
- High-sensitivity C-reactive protein (hsCRP) level ≥2 mg/L
Who cannot join
- Any prior exposure to chemotherapy, radiotherapy or systemic anti-cancer therapy (e.g., monoclonal antibody therapy) for lung cancer.
- 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
- Currently participating in, or has participated in, a trial of an investigational agent within 4 weeks prior to the first dose of study treatment or 5 half-lives, whichever is longer and with recovery of clinically significant toxicities from that therapy.
- Tumors known to express driver mutations of the EGFR or ALK pathways.
- Known severe hypersensitivity (Grade ≥3) to FL-101, its active substance, or any of its excipients
- Known history of human immunodeficiency virus or active Hepatitis B or Hepatitis C infection
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- Additional Exclusion Criteria for Patients with Stage II and III Disease
- Prior treatment with anti-PD-1, anti-CTLA-4, or anti-PD-L1 therapeutic antibody or pathway-targeting agents
- 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
- Known severe hypersensitivity (Grade ≥3) to nivolumab or chemotherapy agents or to any of their excipients.
About this study
Official title: A Two-cohort, Phase 2 Study of FL-101 as Neoadjuvant Therapy in Patients With Surgically Resectable Non-Small Cell Lung Cancer
Phase 2 trial to study FL-101 alone or in combination with nivolumab in patients who have surgically resectable Non-Small Cell Lung Cancer.
Read the detailed description
A 2-Cohort, Phase 2, multicenter, parallel-design trial that will study patients with surgically resectable, stages I-IIIA, non-small cell lung cancer (NSCLC) . The clinical study will focus on whether FL-101 has direct anti-tumor activity when given alone prior to surgery, and if FL-101 improves the anti-tumor response when given in combination with nivolumab prior to surgery.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- FL-101, Nivolumab, Placebo
- Keywords
- Surgically Resectable, NSCLC, Nivolumab, FL-101, Placebo
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FL-101Drug
200 mg administered intravenously every 2 weeks prior to surgery.
NivolumabDrug
240 mg administered intravenously every 2 weeks prior to surgery.
PlaceboDrug
200 mg administered intravenously every 2 weeks prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| FL-101 Monotherapy | Experimental | 30 patients will receive FL-101 prior to surgery. Receives: Drug: FL-101 |
| FL-101 + Nivolumab | Experimental | 30 patients will receive FL-101 and Nivolumab prior to surgery. Receives: Drug: FL-101; Drug: Nivolumab |
| Nivolumab + Placebo | Active comparator | 30 patients will receive Nivolumab and placebo prior to surgery. Receives: Drug: Nivolumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with treatment related adverse events as assessed by NCI CTCAE v.5.0
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.
Measured: From time of first dose to 3 months after surgery
Secondary outcomes (5)
Number of patients with treatment efficacy as assessed by pathological response (percentage of residual tumor) by independent pathology review.
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
Measured: At time of surgery (around 6-8 weeks)
Major Pathologic Response
To determine major pathologic response (MPR), defined as ≤10 percent viable tumor
Measured: At time of surgery (around 6-8 weeks after first dose)
Complete Pathologic Response
To estimate complete pathologic response (CPR), defined as the absence of residual invasive cancer in resected lung specimens and lymph nodes
Measured: At time of surgery (around 6-8 weeks after first dose)
Objective Response Rate (ORR)
To estimate objective response rate (ORR) by RECIST 1.1
Measured: At time of surgery (around 6-8 weeks after first dose)
MRD measurement by ctDNA
To describe the time course of minimal residual disease (MRD) response by ctDNA and recurrence in correlation with clinical response
Measured: From time of first dose to 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start25 Aug 2021
- Primary completion22 Dec 2021
- Study completion22 Dec 2021
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Flame Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cassandra Choe-Juliak, MD, Study director, Flame Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758949
- Sponsor's protocol ID
- FL-101-2001
- Status last verified
- Dec 2021
- First submitted
- 10 Feb 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-cohort, Phase 2 Study of FL-101 as Neoadjuvant Therapy in Patients With Surgically Resectable Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04758949
- Acronym / sponsor ID
- FL-101-2001
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Surgically Resectable, NSCLC, Nivolumab, FL-101, Placebo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Flame BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 22 Dec 2021 (actual)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 2 trial to study FL-101 alone or in combination with nivolumab in patients who have surgically resectable Non-Small Cell Lung Cancer.
Detailed description
A 2-Cohort, Phase 2, multicenter, parallel-design trial that will study patients with surgically resectable, stages I-IIIA, non-small cell lung cancer (NSCLC) . The clinical study will focus on whether FL-101 has direct anti-tumor activity when given alone prior to surgery, and if FL-101 improves the anti-tumor response when given in combination with nivolumab prior to surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FL-101 Monotherapy | Experimental | Drug: FL-10130 patients will receive FL-101 prior to surgery. |
| FL-101 + Nivolumab | Experimental | Drug: FL-101, Drug: Nivolumab30 patients will receive FL-101 and Nivolumab prior to surgery. |
| Nivolumab + Placebo | Active comparator | Drug: Nivolumab, Drug: Placebo30 patients will receive Nivolumab and placebo prior to surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Previously untreated and pathologically confirmed, surgically resectable Stage IA3, IB, II, or IIIA NSCLC of squamous or non-squamous histology.
- ≥1 radiologically measurable tumor >2cm in diameter.
- Smoking history ≥10 pack years.
- Available tissue block for analysis from a core needle biopsy(or similar sample)
- High-sensitivity C-reactive protein (hsCRP) level ≥2 mg/L
Key exclusion criteria (10 listed)
- Any prior exposure to chemotherapy, radiotherapy or systemic anti-cancer therapy (e.g., monoclonal antibody therapy) for lung cancer.
- 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
- Currently participating in, or has participated in, a trial of an investigational agent within 4 weeks prior to the first dose of study treatment or 5 half-lives, whichever is longer and with recovery of clinically significant toxicities from that therapy.
- Tumors known to express driver mutations of the EGFR or ALK pathways.
- Known severe hypersensitivity (Grade ≥3) to FL-101, its active substance, or any of its excipients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FL-101200 mg administered intravenously every 2 weeks prior to surgery. | Drug | FL-101 + Nivolumab, FL-101 Monotherapy |
| Nivolumab240 mg administered intravenously every 2 weeks prior to surgery. | Drug | FL-101 + Nivolumab, Nivolumab + Placebo |
| Placebo200 mg administered intravenously every 2 weeks prior to surgery. | Drug | Nivolumab + Placebo |
Primary outcome
Number of patients with treatment related adverse events as assessed by NCI CTCAE v.5.0
Time frame: From time of first dose to 3 months after surgery
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.
5 secondary outcomes
Number of patients with treatment efficacy as assessed by pathological response (percentage of residual tumor) by independent pathology review.
Time frame: At time of surgery (around 6-8 weeks)
Major Pathologic Response
Time frame: At time of surgery (around 6-8 weeks after first dose)
Complete Pathologic Response
Time frame: At time of surgery (around 6-8 weeks after first dose)
Objective Response Rate (ORR)
Time frame: At time of surgery (around 6-8 weeks after first dose)
MRD measurement by ctDNA
Time frame: From time of first dose to 3 months after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cassandra Choe-Juliak, MD study director
Flame Biosciences
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FL-101 and Nivolumab in people with Non-Small Cell Lung Cancer, run by Flame Biosciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with treatment related adverse events as assessed by NCI CTCAE v.5.0 (time frame: From time of first dose to 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.