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Non-Small Cell Lung CancerPhase 1NCT07910942

A Phase 1 Trial of KAN-001 With Pembrolizumab, With or Without Chemotherapy, in Participants With PD-L1-Positive Non-Small Cell Lung Cancer

A Phase 1 study testing KAN-001 and Pembrolizumab in people with Non-Small Cell Lung Cancer, run by Kanvas Biosciences at 2 sites in 2 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this Phase 1 clinical trial is to learn whether KAN-001, an investigational live biotherapeutic product, can be safely given with pembrolizumab, with or without chemotherapy, to adults with PD-L1-positive, inoperable or metastatic 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?
KAN-001 and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesin 2 countries
Study dates
Nov 2026to Dec 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • The participant is willing and able to provide written informed consent for the trial.
  • Histologically/cytologically confirmed diagnosis of NSCLC.
  • Have inoperable or metastatic disease that is measurable based on RECIST v1.1.
  • Not a candidate for any molecular / biomarker directed targeted therapy approved in the country where the participant is enrolled for the treatment of advanced NSCLC, including but not limited to therapies targeting epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), Proto-oncogene tyrosine-protein kinase ROS1 (ROS1), B-RAF-proto-oncogene, serine/threonine kinase, with a valine-to-glutamic acid substitution at amino acid position 600 (BRAF V600E), MET proto-oncogene, receptor tyrosine kinase, exon 14 (MET exon 14), RET proto-oncogene, receptor tyrosine kinase (RET), neurotrophic receptor tyrosine kinase (NTRK), human epidermal growth factor receptor 2 (HER2), Neuregulin 1 (NRG1), and KRAS proto-oncogene, GTPase, with a glycine-to-cysteine-substitution at amino acid position 12 (KRAS-G12C) alterations. Tumors must be negative for EGFR and ALK sensitizing mutations.
  • An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 during screening.
  • Able and willing to tolerate a polyethylene glycol (PEG)-electrolyte bowel preparation and provide stool samples.
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  • Meets the applicable cohort-specific requirements (1 of the following):
  • Cohort 1: Participants not receiving chemotherapy that have PD-L1 tumor proportion score (TPS) of at least 50% and with no prior systemic therapy for inoperable or metastatic disease.
  • Cohort 2: Participants receiving chemotherapy that are PD-L1 positive* with TPS of at least 1% with no prior systemic therapy for inoperable or metastatic disease.
  • Cohort 3: PD-L1 TPS of at least 1% disease progression after at least 4 cycles of immune checkpoint inhibitor therapy combined with chemotherapy; last immune checkpoint inhibitor dose within 60 days before baseline; and progressive disease confirmed by a second computed tomography scan performed at least 4 weeks after the first scan.

Who cannot join

  • Treatment with either a live biotherapeutic product and/or a fecal microbiota transplant therapy (within the past year).
  • Use or planned usage of any probiotic(s) (within 14 days), or use of antibiotics* (within 7 days) prior to KAN-001 administration.
  • Received a live vaccine* (within 30 days) prior to first dose of pembrolizumab.
  • Certain digestive conditions including: prior large bowel gastrointestinal (GI) surgery*, active GI disorders (uncontrolled vomiting, diarrhea, etc.), inflammatory bowel disease (Crohn's, ulcerative colitis) that has required treatment within six months prior to screening, or a known history of an active GI parasitic infection within three months prior to screening.
  • Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks of study treatment* (excluding continuation of ongoing ICI treatment regimen).
  • Has received major surgery within last 4 weeks, without adequate recovery from the toxicity and/or complications from the prior intervention before starting study treatment.
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  • Has received prior radiotherapy within 14 days of study enrollment.*
  • An unwillingness or inability to swallow size 0 capsules.
  • Screening blood test results outside the ranges required by the study, or certain positive tests for HIV, hepatitis B, or hepatitis C.*
  • Any past or current medical, psychiatric, or substance-use condition, therapy, or laboratory abnormality that, in the study doctor's opinion, could affect the study results, prevent full participation in the study, or make participation not in the participant's best interest.
  • Pregnant, breastfeeding, or unwillingness to use protocol-specified contraception.
  • A life expectancy of less than 4 months.
  • History of solid-organ transplantation.
  • Additional active malignancy that could interfere with interpretation of the study, except for certain adequately treated cancers.
  • Symptomatic or unstable brain metastases* or leptomeningeal disease.
  • Clinically significant or uncontrolled cardiovascular disease*.
  • Active interstitial lung disease or pneumonitis, or a history of interstitial lung disease or pneumonitis requiring systemic corticosteroids.
  • Active autoimmune disease that required systemic immunosuppressive treatment within 7 days of KAN-001 administration, or diagnosis of immunodeficiency*.
  • Prior Grade 3 or 4 immune-related adverse events that were symptomatic and required > 6 weeks of immunosuppression.
  • *Exceptions and full details will be discussed with participants by the study team.
  • Note: Additional criteria apply; the study team will confirm full eligibility at screening.

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

VP of Clinical Research contact

(925) 252 5178

kyle@kanvasbio.com

Chief Development Officer contact

lee@kanvasbio.com

2 sites in 2 countries

United States1 site

  • Taylor Cancer Research Center

    Maumee, Ohio, 43537

    Stephanie Ambrose, (567) 402-4502, sambrose@tcrcpt.org

    John J. Nemunaitis, MD

Other trials in United States

Canada1 site

  • Centre hospitalier de l'Université de Montréal (CHUM)

    Montreal, Quebec, H2X 0C1

    Adeline Hamon, Registered Nurse, (514) 890-8000 ext. 30737, parc.eligibilite.chum@ssss.gouv.qc.ca

    Arielle Elkrief, MD

Other trials in Canada

About this study

Official title: A Phase 1 Trial to Evaluate Safety, Tolerability, and Engraftment of KAN-001 in Combination With Pembrolizumab, With or Without Chemotherapy, in Participants With PD-L1-Positive Non-Small Cell Lung Cancer

The goal of this Phase 1 clinical trial is to learn whether KAN-001, an investigational live biotherapeutic product, can be safely given with pembrolizumab, with or without chemotherapy, to adults with PD-L1-positive, inoperable or metastatic non-small cell lung cancer. The main questions it aims to answer are:

  • What side effects occur when KAN-001 is given with pembrolizumab, with or without chemotherapy?
  • Can the microbial strains contained in KAN-001 be detected in participants' stool after treatment?
Read more

Participants will:

  • Complete a bowel preparation before receiving the first dose of KAN-001.
  • Take a loading dose of KAN-001, followed by maintenance doses every 3 weeks.
  • Receive pembrolizumab every 3 weeks. Some participants will also receive chemotherapy.
  • Provide blood, stool, and stool-wipe samples and complete a gastrointestinal symptom diary.
  • Undergo imaging scans and other study assessments to monitor their cancer, health, and safety.
Being tested
KAN-001, Pembrolizumab
Keywords
Non-Small Cell Lung Cancer, NSCLC, Pembrolizumab, Live Biotherapeutic Product, Microbiome, PD-L1 positive, ICI, Metastatic Lung Cancer, Lung Cancer, Keytruda, anti-PD-1, LBP, Immune Checkpoint Inhibitor, CPI, Immune Checkpoint Blockade, ICB, Fecal Microbiota Transplant, FMT, Chemotherapy, Immunotherapy, Checkpoint Inhibitor Resistance
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KAN-001Biological

    Each dose of KAN-001 contains a defined consortium of commensal bacterial strains for oral administration.

  • PembrolizumabBiological

    Each dose of pembrolizumab contains a monoclonal antibody that blocks the programmed cell death protein 1 (PD-1) pathway and is administered by intravenous infusion.

Study groups in NCT07910942
Study groupRoleWhat they receive
Cohort 1: ICI naïve (pembrolizumab)ExperimentalParticipants previously untreated with immune checkpoint inhibitor (ICI), receiving KAN-001 with pembrolizumab.
Receives: Biological: KAN-001
Cohort 2: ICI naïve (pembrolizumab and chemotherapy)ExperimentalParticipants previously untreated with ICI, receiving KAN-001 with pembrolizumab and chemotherapy.
Receives: Biological: KAN-001
Cohort 3: ICI refractory (pembrolizumab)ExperimentalParticipants who have progressed following treatment with ICI in combination with chemotherapy, receiving KAN-001 with pembrolizumab.
Receives: Biological: KAN-001; Biological: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment-Emergent Adverse Events

    Incidence of treatment-emergent adverse events, including clinically significant changes from baseline in clinical laboratory values, vital signs, and electrocardiograms, in participants receiving KAN-001 with pembrolizumab, with or without chemotherapy.

    Measured: From the first dose of KAN-001 through approximately 30 days after the last dose, which may be up to approximately 2 years

Secondary outcomes (1)

  1. Percentage of participants with KAN-001 Engraftment

    The proportion of participants with KAN-001 strains detected after treatment.

    Measured: From baseline (screening) through the end-of-treatment visit, which may be up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07910942
Sponsor's protocol ID
KAN-001-ONC-101
Status last verified
Oct 2026
First submitted
27 Oct 2026
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: The Sponsor does not currently plan to make individual participant data available. Aggregate study results may be published or otherwise publicly disclosed.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KAN-001 and Pembrolizumab in people with Non-Small Cell Lung Cancer, run by Kanvas Biosciences at 2 sites in 2 countries.

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 10 inclusion and 21 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact VP of Clinical Research ((925) 252 5178, kyle@kanvasbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Emergent Adverse Events (time frame: From the first dose of KAN-001 through approximately 30 days after the last dose, which may be up to approximately 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07910942.

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 2 Nov 2026.

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