Non Small Cell Lung CancerPhase 2LUNA-2NCT07890493
Immune Checkpoint Blockade and Chemotherapy With or Without Fecal Microbiota Transplant in Advanced Non-Small Cell Lung Cancer
A Phase 2 study testing LND101, Carboplatin (AUC 5 or 6) and pemetrexed in people with Non Small Cell Lung Cancer, run by Canadian Cancer Trials Group.
Trial summary
This study is being done to answer the following question: Can adding a treatment called Fecal Microbiota Transplant (FMT) to the usual treatment delay the growth or spread of cancer better than the usual treatment alone? FMT treatment changes the bacteria in the gut called the microbiome. 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?
- LND101, Carboplatin (AUC 5 or 6) and pemetrexed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2026to 30 Jun 2031
- Phase
- Phase 2
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
- Participants must have histologically and/or cytologically confirmed advanced or metastatic squamous or non-squamous NSCLC that has negative or low (0-49%) PD-L1 TPS, without a driver mutation with an actionable first-line targeted therapy, for whom ICB + chemotherapy combination is indicated.
- Prior chemotherapy or immunotherapy for non-metastatic disease (e.g. adjuvant and/or neoadjuvant therapy) is allowed if at least 6 months have elapsed prior to enrollment.
- Previous major surgery is permitted provided that surgery occurred at least 14 days prior to participant enrollment and that wound healing has occurred.
- Local therapy, e.g. palliative extra-cranial radiation, is allowed provided a minimum of 14 days have elapsed between the last dose of radiation and date of enrollment.
- Local therapy, e.g. palliative extra-cranial radiation, is allowed provided a minimum of 14 days have elapsed between the last dose of radiation and date of enrollment.
- Participants must have measurable disease as per RECIST 1.1 criteria.
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- Participants must be at least 18 years of age.
- ECOG performance status 0, 1 or 2.
- Participants must have adequate organ and marrow function measured within 28 days prior to enrollment.
- Participant must be able to ingest capsules.
- Participants must consent to provision of, and investigator must agree to submit, a representative archival formalin-fixed paraffin block of tumour tissue for correlative analyses when tumour tissue is available.
- Participants must consent to provision of samples of blood and stool for correlative marker analysis.
- Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French.
- Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements.
- Participants must be accessible for treatment and follow-up.
- Protocol ICB + chemotherapy is to begin within 14 calendar days after participant enrollment. For the experimental arm, FMT is to begin within 7 calendar days of participant enrollment.
- Participants of childbearing potential must have agreed to use a highly effective contraceptive method.
Who cannot join
- Large-cell neuroendocrine carcinoma (LCNEC), pulmonary carcinoid tumour or mixed small cell and non-small cell lung cancer are not eligible. Participants with adenosquamous carcinoma, large-cell carcinoma without a neuroendocrine component, and sarcomatoid carcinomas are eligible
- Participants with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
- Participants with concurrent treatment with other anti-cancer therapy, including experimental therapies.
- Participants with systemic prednisone use >10mg per day or equivalent dose (unless intranasal or inhaled).
- Participants that have received live attenuated vaccination administered within 28 days prior to randomization.
- Participants with absolute contraindications to FMT including: toxic megacolon; inflammatory bowel disease; severe dietary allergies (e.g. shellfish, nuts, seafood) and; total colon resection.
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- Participants with hypersensitivity to PegLyte® or generic equivalents.
- Participants with symptomatic central nervous system (CNS) metastases and/or CNS metastases requiring immunosuppressive doses of systemic corticosteroids (>10 mg/day prednisone equivalents). Participants with known central nervous system metastases who are asymptomatic and on a stable dose of corticosteroids ≤ 10 mg/day prednisone equivalents are eligible.
- Participants with leptomeningeal disease.
- Participants with any uncontrolled autoimmune disease that requires active immunosuppressive agents. Participants with vitiligo, type I diabetes, resolved childhood asthma/atopy are eligible.
- Participants who are solid organ transplantation recipients or likely to receive solid organ transplants in the future
- Participants with active infection may be eligible following recovery. Participants who have received antibiotics require a 14-day wash-out prior to enrollment. Participants should not receive prebiotics or probiotics while receiving protocol treatment and require at least a 3-day wash-out prior to enrollment.
- HIV-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- Participants with the following concomitant illnesses: impaired cardiovascular function (uncontrolled congestive heart failure requiring treatment (NYHA grade > 2), uncontrolled hypertension, acute myocardial cardiac ischemia or unstable angina <6 months prior to study entry, and severe cardiac arrhythmia).
- Participants that are pregnant, breastfeeding or expecting to conceive or father children within the projected duration of the trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase II Randomized Trial of LND101 for Fecal Microbiota Transplantation in Combination With Immune Checkpoint Blockade and Chemotherapy in Participants With Advanced Non-Small Cell Lung Cancer
This study is being done to answer the following question: Can adding a treatment called Fecal Microbiota Transplant (FMT) to the usual treatment delay the growth or spread of cancer better than the usual treatment alone? FMT treatment changes the bacteria in the gut called the microbiome.
Read the detailed description
This study is being done to find out if this approach (adding FMT treatment to the usual approach) is better or worse than the usual approach for advanced non-small cell lung cancer. The usual approach is defined as care most people get for non-small cell lung cancer.
The usual approach for patients who are not in a study is treatment with a type of immunotherapy drugs called immune checkpoint blockade (ICB) as well as chemotherapy drugs. ICB works by activating the immune system to target the cancer. ICB and chemotherapy may help to slow down the growth of cancer and may cause cancer cells to die.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- LND101, Carboplatin (AUC 5 or 6), pemetrexed, Paclitaxel, Pembrolizumab
- Keywords
- Fecal Microbiota Transplant, Immune checkpoint blockade, Chemotherapy
- 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.
LND101Biological
Assigned at enrollment
Carboplatin (AUC 5 or 6)Drug
Standard of care
pemetrexedDrug
Standard of care
PaclitaxelDrug
Standard of care
PembrolizumabDrug
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Standard of Care ICB + Chemotherapy | Active comparator | Not described Receives: Drug: Carboplatin (AUC 5 or 6); Drug: pemetrexed; Drug: Paclitaxel; Drug: Pembrolizumab |
| Arm 2: FMT + Standard of care ICB + Chemotherapy | Experimental | Not described Receives: Biological: LND101; Drug: Carboplatin (AUC 5 or 6); Drug: pemetrexed; Drug: Paclitaxel; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival based on RECIST 1.1 criteria
Measured: 4 years
Secondary outcomes (7)
Overall Survival
Measured: 4 years
Objective Response Rate based on RECIST 1.1 criteria.
Measured: 4 years
Duration of Response according to RECIST 1.1 or iRECIST
Measured: 4 years
Safety and tolerability using the NCI Common Terminology Criteria for Adverse Events Version 5.0
Measured: 4 years
Progression-Free Survival based on iRECIST criteria
Measured: 4 years
Quality of Life (QoL) using the EORTC core QoL questionnaire (QLQ-C30)
Measured: 4 years
Quality of Life (QoL) using the EORTC lung cancer module (QLQ-C13)
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start31 Dec 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion30 Jun 2031 (estimated)
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.
- More trials run by Canadian Cancer Trials GroupThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Cancer Trials Group
- Sponsor type
- Research network
- Collaborators
- Canadian Cancer Society (CCS), Weston Family Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890493
- Sponsor's protocol ID
- BR39
- Acronym
- LUNA-2
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No