Lung CancerPhase 3NCT03348904
Nivolumab and Epacadostat With Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Non-Small Cell Lung Cancer
A Phase 3 study testing Nivolumab, Epacadostat and Carboplatin in people with Lung Cancer, run by Incyte Corporation at 2 sites in United States.
Trial summary
The purpose of this study was to evaluate the efficacy and safety of the combination of nivolumab plus epacadostat in combination with platinum chemotherapy compared with platinum chemotherapy alone, in participants with treatment-naïve Stage 4 or recurrent non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Nivolumab, Epacadostat and Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Dec 2017to 22 May 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologically confirmed stage IV or recurrent NSCLC of squamous or non-squamous histology that is not amenable to therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
- No prior treatment with systemic anti-cancer therapy for Stage IV disease.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to1.
- Measurable disease by computed tomography or magnetic resonance imaging per RECIST v1.1.
- Documentation of program death ligand-1 (PD-L1) status of 0 to 49% by IHC performed by the central laboratory prior to randomization.
- Other protocol inclusion criteria may apply
Who cannot join
- Known epidermal growth factor receptor (EGFR) mutations sensitive to available targeted inhibitor therapy.
- Known ALK or ROS1 rearrangements sensitive to available targeted inhibitor therapy.
- Untreated central nervous system (CNS) metastases.
- Unevaluable PD-L1 status or PD-L1 status of ≥ 50% by IHC performed by a central laboratory.
- Carcinomatous meningitis.
- Active, known or suspected autoimmune disease.
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- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, IDO1 targeted agent, or any other antibody or drug targeting T cell co-stimulation or checkpoint pathways.
- History of allergy or hypersensitivity to platinum-containing compounds or study drug components.
- Physical and laboratory test findings outside the protocol-defined range.
- Other protocol exclusion criteria may apply.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pacific Cancer Medical Center, Inc
Anaheim, California, 92801
Cancer Center of Kansas
Wichita, Kansas, 67214
About this study
Official title: A Phase 3, Randomized, Global Trial of Nivolumab and Epacadostat With Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in First-line Treatment of Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
The purpose of this study was to evaluate the efficacy and safety of the combination of nivolumab plus epacadostat in combination with platinum chemotherapy compared with platinum chemotherapy alone, in participants with treatment-naïve Stage 4 or recurrent non-small cell lung cancer (NSCLC).
- Conditions
- Lung Cancer
- Being tested
- Nivolumab, Epacadostat, Placebo, Carboplatin, Cisplatin
- Keywords
- Non-small cell lung cancer, programmed cell death protein 1 (PD-1) antibody, indoleamine 2,3-dioxygenase (IDO) inhibitor
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called BMS-936558
Nivolumab administered intravenously at the protocol-defined dose every 3 weeks.
EpacadostatDrug
Also called INCB024360
Epacadostat administered orally at the protocol-defined dose twice daily.
PlaceboDrug
Matching placebo for epacadostat administered orally twice daily.
CarboplatinDrug
Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
CisplatinDrug
Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
GemcitabineDrug
Gemcitabine administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
PaclitaxelDrug
Paclitaxel administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
PemetrexedDrug
Pemetrexed administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Optional continuation maintenance every 3 weeks, if eligible.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Nivolumab plus epacadostat in combination with platinum doublet Receives: Drug: Nivolumab; Drug: Epacadostat; Drug: Carboplatin; Drug: Cisplatin; Drug: Gemcitabine; Drug: Paclitaxel; Drug: Pemetrexed |
| Arm B | Active comparator | Platinum doublet chemotherapy Receives: Drug: Carboplatin; Drug: Cisplatin; Drug: Gemcitabine; Drug: Paclitaxel; Drug: Pemetrexed |
| Arm C | Experimental | Nivolumab plus placebo in combination with platinum doublet chemotherapy. Receives: Drug: Nivolumab; Drug: Placebo; Drug: Carboplatin; Drug: Cisplatin; Drug: Gemcitabine; Drug: Paclitaxel; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)
Defined as the time from randomization to the date of death from any cause.
Measured: Approximately 38 months
Progression-free Survival (PFS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)
Defined as the time between the date of randomization and the first date of documented progression assessed by blinded independent central review, or death due to any cause, whichever occurs first.
Measured: Approximately 25 months
Secondary outcomes (6)
Objective Response Rate (ORR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)
Defined as the proportion of participants who achieve a confirmed best response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by blinded independent central review.
Measured: Approximately 25 months
Duration of Response (DOR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)
Defined as the time between the date of first confirmed response and the date of the first documented tumor progression (per RECIST v1.1) assessed by blinded independent central review or death due to any cause, whichever occurs first.
Measured: Approximately 25 months
Estimate of OS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)
Defined as the time from randomization to the date of death from any cause.
Measured: Approximately 38 months
Estimate of PFS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)
Defined as the time between the date of randomization and the first date of documented progression assessed by blinded independent central review or death due to any cause, whichever occurs first.
Measured: Approximately 25 months
Estimate of ORR of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)
Defined as the proportion of participants who achieve a confirmed best response of CR or PR per RECIST v1.1 criteria as assessed by blinded independent central review.
Measured: Approximately 25 months
Estimate of DOR of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)
Defined as the time between the date of first confirmed response and the date of the first documented tumor progression (per RECIST v1.1) assessed by blinded independent central review or death due to any cause, whichever occurs first.
Measured: Approximately 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start27 Dec 2017
- Primary completion22 May 2018
- Study completion22 May 2018
Why it stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Sridhar K. Rabindran, PhD, Study director, Bristol-Myers Squibb Research and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348904
- Sponsor's protocol ID
- CA2099NC/ECHO-309
- Status last verified
- Jun 2019
- First submitted
- 16 Nov 2017
- Last updated
- 13 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Global Trial of Nivolumab and Epacadostat With Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in First-line Treatment of Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT03348904
- Acronym / sponsor ID
- CA2099NC/ECHO-309
- Conditions
- Lung Cancer
- Keywords
- Non-small cell lung cancer, programmed cell death protein 1 (PD-1) antibody, indoleamine 2,3-dioxygenase (IDO) inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- 27 Dec 2017 (actual)
- Primary completion
- 22 May 2018 (actual)
- Study completion
- 22 May 2018 (actual)
- First posted
- 21 Nov 2017 (actual)
- Results
- Posted 13 Jun 2019
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 was to evaluate the efficacy and safety of the combination of nivolumab plus epacadostat in combination with platinum chemotherapy compared with platinum chemotherapy alone, in participants with treatment-naïve Stage 4 or recurrent non-small cell lung cancer (NSCLC).
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 |
|---|---|---|
| Arm A | Experimental | Drug: Nivolumab, Drug: Epacadostat, Drug: Carboplatin, Drug: Cisplatin, Drug: Gemcitabine, Drug: Paclitaxel, Drug: PemetrexedNivolumab plus epacadostat in combination with platinum doublet |
| Arm B | Active comparator | Drug: Carboplatin, Drug: Cisplatin, Drug: Gemcitabine, Drug: Paclitaxel, Drug: PemetrexedPlatinum doublet chemotherapy |
| Arm C | Experimental | Drug: Nivolumab, Drug: Placebo, Drug: Carboplatin, Drug: Cisplatin, Drug: Gemcitabine, Drug: Paclitaxel, Drug: PemetrexedNivolumab plus placebo in combination with platinum doublet chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed stage IV or recurrent NSCLC of squamous or non-squamous histology that is not amenable to therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
- No prior treatment with systemic anti-cancer therapy for Stage IV disease.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to1.
- Measurable disease by computed tomography or magnetic resonance imaging per RECIST v1.1.
- Documentation of program death ligand-1 (PD-L1) status of 0 to 49% by IHC performed by the central laboratory prior to randomization.
Key exclusion criteria (10 listed)
- Known epidermal growth factor receptor (EGFR) mutations sensitive to available targeted inhibitor therapy.
- Known ALK or ROS1 rearrangements sensitive to available targeted inhibitor therapy.
- Untreated central nervous system (CNS) metastases.
- Unevaluable PD-L1 status or PD-L1 status of ≥ 50% by IHC performed by a central laboratory.
- Carcinomatous meningitis.
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 |
|---|---|---|
| NivolumabAlso: BMS-936558Nivolumab administered intravenously at the protocol-defined dose every 3 weeks. | Drug | Arm A, Arm C |
| EpacadostatAlso: INCB024360Epacadostat administered orally at the protocol-defined dose twice daily. | Drug | Arm A |
| PlaceboMatching placebo for epacadostat administered orally twice daily. | Drug | Arm C |
| CarboplatinCarboplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. | Drug | Arm A, Arm B, Arm C |
| CisplatinCisplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. | Drug | Arm A, Arm B, Arm C |
| GemcitabineGemcitabine administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. | Drug | Arm A, Arm B, Arm C |
| PaclitaxelPaclitaxel administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. | Drug | Arm A, Arm B, Arm C |
| PemetrexedPemetrexed administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Optional continuation maintenance every 3 weeks, if eligible. | Drug | Arm A, Arm B, Arm C |
Primary outcome
Overall Survival (OS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)
Time frame: Approximately 38 months
Defined as the time from randomization to the date of death from any cause.
Progression-free Survival (PFS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)
Time frame: Approximately 25 months
Defined as the time between the date of randomization and the first date of documented progression assessed by blinded independent central review, or death due to any cause, whichever occurs first.
6 secondary outcomes
Objective Response Rate (ORR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)
Time frame: Approximately 25 months
Duration of Response (DOR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)
Time frame: Approximately 25 months
Estimate of OS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)
Time frame: Approximately 38 months
Estimate of PFS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)
Time frame: Approximately 25 months
Estimate of ORR of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)
Time frame: Approximately 25 months
Estimate of DOR of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)
Time frame: Approximately 25 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Sridhar K. Rabindran, PhD study director
Bristol-Myers Squibb Research and Development
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nivolumab, Epacadostat and Carboplatin in people with Lung Cancer, run by Incyte Corporation at 2 sites in United States.
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 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: stopped early, as of the sponsor's last update on 13 Jun 2019. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Survival (OS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B) (time frame: Approximately 38 months). The study lists 2 primary outcomes in all. 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 13 Jun 2019.