Non Small Cell Lung Cancer MetastaticPhase 2FMT-LUMINATENCT04951583
Fecal Microbial Transplantation Non-Small Cell Lung Cancer and Melanoma
A Phase 2 study testing FMT + ICI in people with Non Small Cell Lung Cancer Metastatic and Advanced Melanoma, run by Centre hospitalier de l'Université de Montréal (CHUM) at 6 sites in Canada.
Trial summary
The aim of this study is to assess the anti-tumor activity of FMT administered in combination with ICI therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer Metastatic, Advanced Melanoma
- What is being tested?
- FMT + ICI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 6 sitesCanada
- Study dates
- 16 Nov 2021to 1 Sep 2025
- 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
- Signed, informed consent;
- Patients must be able to understand the infectious and non-infectious risks associated with FMT administration;
- Must understand that data regarding the long-term safety risks of FMT administration are lacking;
- Age 18 years or older;
- Confirmed histological diagnosis of either: unresectable or metastatic melanoma, unresectable or metastatic uveal melanoma, or unresectable or metastatic non-small cell lung cancer (NSCLC);
- Stage IV or unresectable disease;
Show all 15Show fewer
- No prior anti-PD1 treatment;
- For patients with newly diagnosed metastatic melanoma who relapsed after adjuvant immunotherapy, patients can be included in this study if they relapsed >6 months after their last dose of immunotherapy given in the adjuvant setting;
- For patients with NSCLC, tumor PD-L1 expression level 50%
- Evaluable disease as per iRECIST;
- ECOG performance status of 0-2;
- Ability to ingest capsules;
- Patients receiving systemic steroids at physiologic doses are permitted to enroll assuming steroid dose is not above the acceptable threshold (< 10 mg prednisone daily or equivalent permitted);
- Negative pregnancy test for women of child-bearing potential; and
- Highly effective contraception for both male and female subjects throughout the study and for at least 60 days after last treatment administration if the risk of conception exists
Who cannot join
- Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
- Current or recent [in the last 90 days] exposure to high dose oral or IV corticosteroids
- Patients who require intermittent use of bronchodilators or local steroid injections are not excluded from the study.
- Has a diagnosis of immunodeficiency (e.g. HIV, transplantation) or receiving systemic steroid therapy (>10mg prednisone daily or equivalent) or any other form of immunosuppressive therapy one year prior to trial treatment.
- Presence of a chronic debilitating intestinal disease (e.g. Malabsorption, colonic tumor)
- Use of probiotics during FMT. Probiotics must be discontinued a minimum of 24 hours before FMT administration and patients are not permitted to take probiotics during the course of immunotherapy treatment.
Show all 24Show fewer
- Use of antibiotics within 2 weeks of enrollment in the study.
- Presence of absolute contra-indications to FMT administration
- Toxic megacolon
- Severe dietary allergies (e.g. shellfish, nuts, seafood)
- Active inflammatory bowel disease
- Expected to require any other form of systemic or localized anti-neoplastic therapy while on study.
- Has a known history of a hematologic malignancy, primary brain tumor or sarcoma, or of another primary solid tumor, unless the patient has undergone potentially curative therapy with no evidence of that disease for two years.
- NOTE: This time requirement does not apply to patients who underwent successful definitive resection of basal or squamous cell carcinoma of the skin, superficial bladder cancer, in situ cancers including cervical cancer, breast cancer, melanoma, or other in situ cancers.
- Active untreated central nervous system (CNS) metastases and/or leptomeningeal involvement (leptomeningeal enhancement on MRI/CT imaging and/or positive CSF cytology).
- Has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents.
- Patients with vitiligo, type I diabetes, resolved childhood asthma/atopy are exceptions to this exclusion criteria.
- A history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- Has serious concomitant illnesses, such as: impaired cardiovascular function of clinically significant cardiovascular disease (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), active systemic infections, and active inflammatory bowel disorders.
- This includes HIV or AIDS-related illness, or active HBV and HCV.
- Has an active infection requiring systemic therapy.
- Patient has received a live vaccine within 4 weeks prior to the first dose of treatment
- Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
London Health Sciences Centre
London, Ontario, N6A 5W9
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4
McGill University Health Center
Montreal, Quebec, H4A 3J1
DRCC Lakeridge Health
Oshawa, Ontario, L1G 8A2
CHU de Québec, Centre intégré en cancérologie (CIC), Hôpital de L'Enfant-Jésus
Québec, Quebec, G1J 1Z4
Sunnybrook Health Sciences Centre/Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5
About this study
Official title: Phase II Trial of Fecal Microbial Transplantation in Patients With Advanced Non-Small Cell Lung Cancer and Melanoma Treated With Immune Checkpoint Inhibitors.
The aim of this study is to assess the anti-tumor activity of FMT administered in combination with ICI therapy.
Read the detailed description
Immune-checkpoint inhibitors (ICI) now represent the backbone therapy for patients with advanced or unresectable non-small cell lung cancer (NSCLC) and melanoma. With the use of anti-PD-1 (Pembrolizumab), overall survival (OS) is now 45% at two years for patients with metastatic NSCLC with a PD-L1 expression level above 50%. The OS for patients with metastatic melanoma is now 52% at five years with combination therapy of anti-CLTA-4 (Ipilimumab) and anti-PD-1 (Nivolumab).
However, only a minority of patients obtain durable responses and current biomarkers are unable to consistently and accurately predict response to ICI. Addressing these unmet needs, the gut microbiome has emerged as a potential biomarker of response to ICI. Modulating the gut microbiome to improve response to ICI is an active area of study. One way to modify the gut microbiome composition is through fecal microbial transplantation (FMT) and pre-clinical studies showed improved effectiveness of ICI when mice received FMT from lung cancer patients responding to ICI. Recently, 2 phase I clinical studies published in Science consolidated these findings, and demonstrated the safety of FMT in patients with melanoma treated with ICI.
Building on phase I studies showing that FMT is safe in patients with cancer receiving ICI, and compelling data demonstrating the potential of FMT to reverse ICI resistance, there is a strong rationale to further study the role of FMT in improving ICI efficacy in patients with melanoma and NSCLC treated with ICI in the first-line setting in a phase II study.
Our primary objective is to assess the impact of FMT on ICI response and survival. Other goals of this trial are to study the changes in the patient's gut microbiome composition and tumor microenvironment contexture following the combination treatment of ICI and FMT. Efficacy of FMT in terms of response rate and overall survival in patients with metastatic melanoma and uveal melanoma will be studies as part of an exploratory endpoint.
- Being tested
- FMT + ICI
- Keywords
- FMT, ICI, Advanced NSCLC, advanced melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMT + ICICombination product
This study will include 3 cohorts of patients: (1) Patients with advanced or unresectable NSCLC, (2) patients with advanced or unresectable melanoma, and (3) patients with unresectable or advanced uveal melanoma. Patients with NSCLC, melanoma, uveal melanoma and will be analyzed in three separate subgroups given their differing clinical outcomes.
Each group will be treated with ICI as per their respective first line options, in combination with investigational FMT capsules.
| Study group | Role | What they receive |
|---|---|---|
| Immune checkpoint inhibitor (ICI) therapy in combination with fecal microbial transplantation (FMT). | Experimental | Metastatic or advanced NSCLC: Single-agent Pembrolizumab (2 mg/kg or 200 mg every 3 weeks) in combination with investigational FMT capsules as follows: Full FMT at least 7 days prior to first cycle of Pembrolizumab.
Metastatic melanoma and uveal melanoma: Combination therapy of Ipilimumab plus Nivolumab (Ipilimumab 3 mg/kg every 3 weeks and Nivolumab 1 mg/kg every 3 weeks x 4 doses, followed by Nivolumab 3 mg/kg or 240mg every 2 weeks or 6 mg/kg or 480mg every 4 weeks) in combination with investigational FMT capsules as follows: full FMT at least 7 days prior to first treatment with Ipilimumab plus Nivolumab, followed by supportive FMT within 7 days of the second cycle with combination Ipilimumab plus Nivolumab, followed by supportive FMT within 7 days of the third cycle of Ipilimumab plus Nivolumab. Receives: Combination Product: FMT + ICI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate in the NSCLC cohort by RECIST criteria.
Objective Response Rate (ORR) as defined by the proportion of patients with NSCLC whose Best Overall Response (BOR) is either a complete response (CR) or partial response (PR) as assessed by iRECIST, based on RECIST v1.1. BOR is defined as the best response designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy. CR or PR determinations included in the BOR assessment must be confirmed by a second scan performed no less than 4 weeks after the criteria for response are first met.
Measured: up to 2 years
Secondary outcomes (4)
Progression-free survival at 1 year in the NSCLC cohort by RECIST criteria.
Progression-free survival (PFS) at 1 year as assessed by iRECIST and RECIST. PFS is defined by the proportion of treated subjects remaining progression-free and surviving at 1 year, defined as the time from registration to disease progression or death from any cause. The proportion will be calculated by the Kaplan-Meier estimate, which takes into account censored data.
Measured: At 3 and 6 months, then at 12 months and up to 2 years
Overall survival at 1 year in the NSCLC cohort assessed by RECIST criteria.
Overall survival (OS) at 1 year as assessed by iRECIST and RECIST radiology, defined by OS will be defined as the time of patient registration to the time of death from any cause. The proportion will be calculated by the Kaplan-Meier estimate, which takes into account censored data.
Measured: At 3 and 6 months, then at 12 months and up to 2 years
Incidence of treatment-related adverse events (Safety and tolerability)
Safety of administration of FMT in combination with ICI in the Safety Analysis Dataset. The assessment of safety will be based on the incidence of AEs, SAEs, AEs leading to discontinuation, and deaths in the Safety Analysis dataset.
Treatment-related adverse events will be graded according to the NCI CTCAE v5.0.
Measured: Safety follow-up will be maintained up to 90 days following the administration of the last study-drug dose.
Incidence of treatment-related laboratory test abdnomarlities (Safety and tolerability)
Clinical laboratory test abnormalities will be examined. Laboratory values will be graded according to the NCI CTCAE v5.0.
Measured: Safety follow-up will be maintained up to 90 days following the administration of the last study-drug dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start16 Nov 2021
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a multi-center single-arm, open-label Simon two-stage, phase II trial in patients with metastatic or unresectable non-small cell lung cancer (NSCLC) and melanoma treated with immune checkpoint inhibition. Patients will receive standard-of-care immune checkpoint inhibitor (ICI) therapy in combination with fecal microbial transplantation (FMT).
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arielle Elkrief, MD, Principal investigator, CHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04951583
- Sponsor's protocol ID
- 21.173
- Acronym
- FMT-LUMINATE
- Status last verified
- Aug 2024
- First submitted
- 18 Jun 2021
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Duttagupta S, Messaoudene M, Hunter S, Desilets A, Jamal R, Mihalcioiu C, Belkaid W, Marcoux N, Fidelle M, Suissa D, Ponce M, Geiger M, Malo J, Piccinno G, Puncochar M, Filin A, Heidrich V, Rusu D, Mbaye B, Durand S, Ben Aissa I, Puller V, de Lahondes R, Blais N, Tehfe M, Owen S, Belanger K, Parvathy SN, Shieh B, Raphael J, Lenehan J, Breadner D, Rothenstein J, Rozza N, Maillou J, Nili S, Prifti DK, Pinto F, Armanini F, Kim-Schulze S, Marron TU, Kroemer G, Derosa L, Zitvogel L, Silverman M, Segata N, Maleki Vareki S, Routy B, Elkrief A. Fecal microbiota transplantation plus immunotherapy in non-small cell lung cancer and melanoma: the phase 2 FMT-LUMINate trial. Nat Med. 2026 Apr;32(4):1337-1350. doi: 10.1038/s41591-025-04186-5. Epub 2026 Jan 28.
PubMed 41606121
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Fecal Microbial Transplantation in Patients With Advanced Non-Small Cell Lung Cancer and Melanoma Treated With Immune Checkpoint Inhibitors.
- ClinicalTrials.gov ID
- NCT04951583
- Acronym / sponsor ID
- FMT-LUMINATE / 21.173
- Keywords
- FMT, ICI, Advanced NSCLC, advanced melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 7 Jul 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.
The aim of this study is to assess the anti-tumor activity of FMT administered in combination with ICI therapy.
Detailed description
Immune-checkpoint inhibitors (ICI) now represent the backbone therapy for patients with advanced or unresectable non-small cell lung cancer (NSCLC) and melanoma. With the use of anti-PD-1 (Pembrolizumab), overall survival (OS) is now 45% at two years for patients with metastatic NSCLC with a PD-L1 expression level above 50%. The OS for patients with metastatic melanoma is now 52% at five years with combination therapy of anti-CLTA-4 (Ipilimumab) and anti-PD-1 (Nivolumab).
However, only a minority of patients obtain durable responses and current biomarkers are unable to consistently and accurately predict response to ICI. Addressing these unmet needs, the gut microbiome has emerged as a potential biomarker of response to ICI. Modulating the gut microbiome to improve response to ICI is an active area of study. One way to modify the gut microbiome composition is through fecal microbial transplantation (FMT) and pre-clinical studies showed improved effectiveness of ICI when mice received FMT from lung cancer patients responding to ICI. Recently, 2 phase I clinical studies published in Science consolidated these findings, and demonstrated the safety of FMT in patients with melanoma treated with ICI.
Building on phase I studies showing that FMT is safe in patients with cancer receiving ICI, and compelling data demonstrating the potential of FMT to reverse ICI resistance, there is a strong rationale to further study the role of FMT in improving ICI efficacy in patients with melanoma and NSCLC treated with ICI in the first-line setting in a phase II study.
Our primary objective is to assess the impact of FMT on ICI response and survival. Other goals of this trial are to study the changes in the patient's gut microbiome composition and tumor microenvironment contexture following the combination treatment of ICI and FMT. Efficacy of FMT in terms of response rate and overall survival in patients with metastatic melanoma and uveal melanoma will be studies as part of an exploratory endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a multi-center single-arm, open-label Simon two-stage, phase II trial in patients with metastatic or unresectable non-small cell lung cancer (NSCLC) and melanoma treated with immune checkpoint inhibition. Patients will receive standard-of-care immune checkpoint inhibitor (ICI) therapy in combination with fecal microbial transplantation (FMT).
| Arm | Type | Receives |
|---|---|---|
| Immune checkpoint inhibitor (ICI) therapy in combination with fecal microbial transplantation (FMT). | Experimental | Combination Product: FMT + ICIMetastatic or advanced NSCLC: Single-agent Pembrolizumab (2 mg/kg or 200 mg every 3 weeks) in combination with investigational FMT capsules as follows: Full FMT at least 7 days prior to first cycle of Pembrolizumab. Metastatic melanoma and uveal melanoma: Combination therapy of Ipilimumab plus Nivolumab (Ipilimumab 3 mg/kg every 3 weeks and Nivolumab 1 mg/kg every 3 weeks x 4 doses, followed by Nivolumab 3 mg/kg or 240mg every 2 weeks or 6 mg/kg or 480mg every 4 weeks) in combination with investigational FMT capsules as follows: full FMT at least 7 days prior to first treatment with Ipilimumab plus Nivolumab, followed by supportive FMT within 7 days of the second cycle with combination Ipilimumab plus Nivolumab, followed by supportive FMT within 7 days of the third cycle of Ipilimumab plus Nivolumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Signed, informed consent;
- Patients must be able to understand the infectious and non-infectious risks associated with FMT administration;
- Must understand that data regarding the long-term safety risks of FMT administration are lacking;
- Age 18 years or older;
- Confirmed histological diagnosis of either: unresectable or metastatic melanoma, unresectable or metastatic uveal melanoma, or unresectable or metastatic non-small cell lung cancer (NSCLC);
Key exclusion criteria (24 listed)
- Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
- Current or recent [in the last 90 days] exposure to high dose oral or IV corticosteroids
- Has a diagnosis of immunodeficiency (e.g. HIV, transplantation) or receiving systemic steroid therapy (>10mg prednisone daily or equivalent) or any other form of immunosuppressive therapy one year prior to trial treatment.
- Presence of a chronic debilitating intestinal disease (e.g. Malabsorption, colonic tumor)
- Use of antibiotics within 2 weeks of enrollment in the study.
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 |
|---|---|---|
| FMT + ICIThis study will include 3 cohorts of patients: (1) Patients with advanced or unresectable NSCLC, (2) patients with advanced or unresectable melanoma, and (3) patients with unresectable or advanced uveal melanoma. Patients with NSCLC, melanoma, uveal melanoma and will be analyzed in three separate subgroups given their differing clinical outcomes. Each group will be treated with ICI as per their respective first line options, in combination with investigational FMT capsules. | Combination product | Immune checkpoint inhibitor (ICI) therapy in combination with fecal microbial transplantation (FMT). |
Primary outcome
Objective response rate in the NSCLC cohort by RECIST criteria.
Time frame: up to 2 years
Objective Response Rate (ORR) as defined by the proportion of patients with NSCLC whose Best Overall Response (BOR) is either a complete response (CR) or partial response (PR) as assessed by iRECIST, based on RECIST v1.1. BOR is defined as the best response designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy. CR or PR determinations included in the BOR assessment must be confirmed by a second scan performed no less than 4 weeks after the criteria for response are first met.
4 secondary outcomes
Progression-free survival at 1 year in the NSCLC cohort by RECIST criteria.
Time frame: At 3 and 6 months, then at 12 months and up to 2 years
Overall survival at 1 year in the NSCLC cohort assessed by RECIST criteria.
Time frame: At 3 and 6 months, then at 12 months and up to 2 years
Incidence of treatment-related adverse events (Safety and tolerability)
Time frame: Safety follow-up will be maintained up to 90 days following the administration of the last study-drug dose.
Incidence of treatment-related laboratory test abdnomarlities (Safety and tolerability)
Time frame: Safety follow-up will be maintained up to 90 days following the administration of the last study-drug dose.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Derived from this study: PubMed 41606121Duttagupta S, Messaoudene M, Hunter S, Desilets A, Jamal R, Mihalcioiu C, Belkaid W, Marcoux N, Fidelle M, Suissa D, Ponce M, Geiger M, Malo J, Piccinno G, Puncochar M, Filin A, Heidrich V, Rusu D, Mbaye B, Durand S, Ben Aissa I, Puller V, de Lahondes R, Blais N, Tehfe M, Owen S, Belanger K, Parvathy SN, Shieh B, Raphael J, Lenehan J, Breadner D, Rothenstein J, Rozza N, Maillou J, Nili S, Prifti DK, Pinto F, Armanini F, Kim-Schulze S, Marron TU, Kroemer G, Derosa L, Zitvogel L, Silverman M, Segata N, Maleki Vareki S, Routy B, Elkrief A. Fecal microbiota transplantation plus immunotherapy in non-small cell lung cancer and melanoma: the phase 2 FMT-LUMINate trial. Nat Med. 2026 Apr;32(4):1337-1350. doi: 10.1038/s41591-025-04186-5. Epub 2026 Jan 28.
Related trials for Non Small Cell Lung Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 3
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
NSCLC (Non-small Cell Lung Cancer), Non-Small Cell Lung Cancer
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.
Arielle Elkrief, MD principal investigator
CHUM
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FMT + ICI in people with Non Small Cell Lung Cancer Metastatic and Advanced Melanoma, run by Centre hospitalier de l'Université de Montréal (CHUM) at 6 sites in Canada.
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 15 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in 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 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?
Results are not available in the source record.
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?
Objective response rate in the NSCLC cohort by RECIST criteria. (time frame: up to 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 NCT04951583, which also lists 1 linked publication.
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 7 Aug 2024.