Non-Small Cell Lung CancerPhase 2CheckMate 9TNNCT03770299
An Investigational Immuno-therapy Study of Nivolumab Given After Surgery in Non-Small Cell Lung Cancer (NSCLC) Participants With Minimal Residual Disease
A Phase 2 study testing Nivolumab, Vinorelbine and Gemcitabine in people with Non-Small Cell Lung Cancer and Non-Small-Cell Lung Carcinoma, run by Bristol-Myers Squibb.
Trial summary
The purpose of this study is to determine if nivolumab added to the standard of care therapy (SOC) given after surgery is more effective than SOC alone in prolonging disease free survival in NSCLC participants with minimal residual disease detected after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Non-Small-Cell Lung Carcinoma, Circulating Tumor DNA
- What is being tested?
- Nivolumab, Vinorelbine and Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2021to 14 Mar 2024
- 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
- Suspected or histologically confirmed Stage IIA to IIIB NSCLC with disease that is considered resectable
- Must be deemed eligible for complete resection and must agree to undergo standard of care surgery for complete resection of NSCLC
- Treatment naive (no previous systemic treatment)
- Must have undergone complete surgical resection of their Stage IIA to IIIB NSCLC
- Must have adequately recovered from surgery at the time of randomization
- Minimal residual disease (MRD) positive results as detected by ctDNA
Who cannot join
- Participants with known EGFR mutations which are sensitive to available targeted inhibitor therapy (Prior to treatment randomization in select sites)
- Active, known or suspected autoimmune disease
- Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization
- Must continue to meet Exclusion Criteria prior to Surgery
- Must have no evidence of metastatic disease after surgery
- Received a live/attenuated vaccine within 30 days of first treatment
- Other protocol defined inclusion/exclusion criteria apply
About this study
Official title: A Phase 2 Multi-Center Randomized Trial to Assess Early Intervention With Adjuvant Nivolumab in Non-Small Cell Lung Cancer Participants With ctDNA-detected Minimal Residual Disease After Surgical Resection
The purpose of this study is to determine if nivolumab added to the standard of care therapy (SOC) given after surgery is more effective than SOC alone in prolonging disease free survival in NSCLC participants with minimal residual disease detected after surgery.
- Being tested
- Nivolumab, Vinorelbine, Gemcitabine, Docetaxel, Pemetrexed
- 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.
NivolumabBiological
Specified dose on specified days
VinorelbineDrug
Specified dose on specified days
GemcitabineDrug
Specified dose on specified days
DocetaxelDrug
Specified dose on specified days
PemetrexedDrug
Specified dose on specified days
CisplatinDrug
Specified dose on specified days
CarboplatinDrug
Specified dose on specified days
PaclitaxelDrug
Specified dose on specified days
ObservationOther
Observation by the investigator
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Nivolumab + SOC (chemotherapy in eligible participants or observation) Receives: Biological: Nivolumab; Drug: Vinorelbine; Drug: Gemcitabine; Drug: Docetaxel; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel; Other: Observation |
| Arm B | Active comparator | SOC (chemotherapy in eligible participants or observation) Receives: Drug: Vinorelbine; Drug: Gemcitabine; Drug: Docetaxel; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel; Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS)
Measured: Approximately 24 months
Secondary outcomes (5)
Circulating tumor DNA (ctDNA) response rate
Measured: Approximately 36 months
ctDNA duration of response (DOR)
Measured: Approximately 36 months
ctDNA time to response (TTR)
Measured: Approximately 36 months
Incidence of adverse events (AEs)
Measured: Approximately 36 months
Incidence of serious adverse events (SAEs)
Measured: Approximately 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start15 Jan 2021 (estimated)
- Primary completion14 Mar 2023 (estimated)
- Study completion14 Mar 2024 (estimated)
Why it stopped: Business objectives have changed
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 Bristol-Myers SquibbThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770299
- Sponsor's protocol ID
- CA209-9TN
- Other IDs
- 2018-003719-23, 2018
- Acronym
- CheckMate 9TN
- Status last verified
- Mar 2022
- First submitted
- 7 Dec 2018
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient level data from this study may be shared with qualified researchers, upon request, following the timelines and process detailed on https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multi-Center Randomized Trial to Assess Early Intervention With Adjuvant Nivolumab in Non-Small Cell Lung Cancer Participants With ctDNA-detected Minimal Residual Disease After Surgical Resection
- ClinicalTrials.gov ID
- NCT03770299
- Acronym / sponsor ID
- CheckMate 9TN / CA209-9TN
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business objectives have changed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2021 (estimated)
- Primary completion
- 14 Mar 2023 (estimated)
- Study completion
- 14 Mar 2024 (estimated)
- First posted
- 10 Dec 2018 (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 purpose of this study is to determine if nivolumab added to the standard of care therapy (SOC) given after surgery is more effective than SOC alone in prolonging disease free survival in NSCLC participants with minimal residual disease detected after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Biological: Nivolumab, Drug: Vinorelbine, Drug: Gemcitabine, Drug: Docetaxel, Drug: Pemetrexed, Drug: Cisplatin, Drug: Carboplatin, Drug: Paclitaxel, Other: ObservationNivolumab + SOC (chemotherapy in eligible participants or observation) |
| Arm B | Active comparator | Drug: Vinorelbine, Drug: Gemcitabine, Drug: Docetaxel, Drug: Pemetrexed, Drug: Cisplatin, Drug: Carboplatin, Drug: Paclitaxel, Other: ObservationSOC (chemotherapy in eligible participants or observation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Suspected or histologically confirmed Stage IIA to IIIB NSCLC with disease that is considered resectable
- Must be deemed eligible for complete resection and must agree to undergo standard of care surgery for complete resection of NSCLC
- Treatment naive (no previous systemic treatment)
- Must have undergone complete surgical resection of their Stage IIA to IIIB NSCLC
- Must have adequately recovered from surgery at the time of randomization
Key exclusion criteria (7 listed)
- Participants with known EGFR mutations which are sensitive to available targeted inhibitor therapy (Prior to treatment randomization in select sites)
- Active, known or suspected autoimmune disease
- Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization
- Must continue to meet Exclusion Criteria prior to Surgery
- Must have no evidence of metastatic disease after surgery
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 |
|---|---|---|
| NivolumabSpecified dose on specified days | Biological | Arm A |
| VinorelbineSpecified dose on specified days | Drug | Arm A, Arm B |
| GemcitabineSpecified dose on specified days | Drug | Arm A, Arm B |
| DocetaxelSpecified dose on specified days | Drug | Arm A, Arm B |
| PemetrexedSpecified dose on specified days | Drug | Arm A, Arm B |
| CisplatinSpecified dose on specified days | Drug | Arm A, Arm B |
| CarboplatinSpecified dose on specified days | Drug | Arm A, Arm B |
| PaclitaxelSpecified dose on specified days | Drug | Arm A, Arm B |
| ObservationObservation by the investigator | Other | Arm A, Arm B |
Primary outcome
Disease-free survival (DFS)
Time frame: Approximately 24 months
5 secondary outcomes
Circulating tumor DNA (ctDNA) response rate
Time frame: Approximately 36 months
ctDNA duration of response (DOR)
Time frame: Approximately 36 months
ctDNA time to response (TTR)
Time frame: Approximately 36 months
Incidence of adverse events (AEs)
Time frame: Approximately 36 months
Incidence of serious adverse events (SAEs)
Time frame: Approximately 36 months
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 24 Mar 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual patient level data from this study may be shared with qualified researchers, upon request, following the timelines and process detailed on https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab, Vinorelbine and Gemcitabine in people with Non-Small Cell Lung Cancer and Non-Small-Cell Lung Carcinoma, run by Bristol-Myers Squibb.
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 6 inclusion and 7 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 24 Mar 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?
Disease-free survival (DFS) (time frame: Approximately 24 months). 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 24 Mar 2022.