AzTrials
AzTrials

NSCLC (Non-small Cell Lung Carcinoma)Phase 1NCT02298153

A Study of Atezolizumab in Combination With Epacadostat in Subjects With Previously Treated Stage IIIB or Stage IV Non-Small Cell Lung Cancer and Previously Treated Stage IV Urothelial Carcinoma

A Phase 1 study testing Epacadostat and Atezolizumab in people with NSCLC (Non-small Cell Lung Carcinoma) and UC (Urothelial Cancer), run by Incyte Corporation at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This study evaluated the safety and tolerability of epacadostat (INCB024360) administered in combination with atezolizumab (MPDL3280A) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that were previously treated with platinum-based chemotherapy and Stage IV urothelial carcinoma who… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Epacadostat and Atezolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
6 sitesUnited States
Study dates
27 Jan 2015to 8 Nov 2017
Phase
Phase 1
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

  • Male or female subjects, age 18 years or older
  • Histologically or cytologically confirmed NSCLC
  • Stage IIIB or Stage IV NSCLC who are not candidates for multimodality treatment and have received at least 1 line of standard platinum-based therapy:
  • Prior systemic regimens must include at least 2 cycles of a platinum-based therapy and may include platinum therapy used as a radiosensitizer. Maintenance chemotherapy is allowed.
  • Tumors with driver mutations (epidermal growth factor receptor mutation positive or anaplastic lymphoma kinase fusion oncogene positive) should have had disease progression or been intolerant to the standard tyrosine-kinase inhibitor (TKI), and should include a second line TKI where such therapy is available and indicated.
  • Subjects initially treated with a platinum regimen for Stage IIIB disease who later develop metastatic disease and are re-treated with a platinum regimen are allowed.
Show all 13Show fewer
  • Histologically or cytologically confirmed urothelial carcinoma.
  • Stage IV locally advanced or metastatic urothelial carcinoma with disease progression during or following platinum-containing chemotherapy or had disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
  • Presence of measurable disease per RECIST v1.1
  • Availability of an adequate archival tumor specimen or willingness to undergo a pretreatment tumor biopsy.
  • Subjects enrolled in Expansion Cohort 3 must be willing to have 2 on-treatment tumor biopsies.
  • For males and females of child-bearing potential, willingness to use adequate birth control through 90 days after the last dose of epacadostat or atezolizumab.

Who cannot join

  • Laboratory and medical history parameters not within protocol-defined range.
  • Current treatment with an investigational study drug or immunological-based agent for any reason, or receipt of anticancer medication within 21 days or 5 half-lives (whichever is longer) before first dose.
  • Prior treatment with immune checkpoint inhibitors (eg, anti-CTLA-4, anti-PD-1, anti-PD-L1, and any other antibody or drug specifically targeting T-cell co-stimulation) or an IDO inhibitor.
  • Prior monoclonal antibody within 4 weeks before study Day 1, or has not recovered from adverse events due to agents administered more than 4 weeks earlier.
  • Has an active or inactive autoimmune process.
  • Has a history of pneumonitis or idiopathic pulmonary fibrosis, or evidence of interstitial lung disease.
Show all 10Show fewer
  • Prior radiotherapy within 2 weeks of therapy; Must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
  • Untreated central nervous system (CNS) metastases or CNS metastases that have progressed after completion of radiotherapy.
  • Use of systemic corticosteroids ≤ 2 weeks before Cycle 1 Day 1.
  • Currently pregnant or breastfeeding.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Harvard-Mass General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Yale University

    New Haven, Connecticut, 06510

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Pinnacle Oncology Hematology

    Scottsdale, Arizona, 85258

  • University of Washington

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: A Phase 1 Study of Atezolizumab in Combination With Epacadostat in Subjects With Previously Treated Stage IIIB or Stage IV Non-Small Cell Lung Cancer and Previously Treated Stage IV Urothelial Carcinoma

This study evaluated the safety and tolerability of epacadostat (INCB024360) administered in combination with atezolizumab (MPDL3280A) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that were previously treated with platinum-based chemotherapy and Stage IV urothelial carcinoma who failed a platinum-based chemotherapy regimen. The study was conducted in two phases. The dose escalation phase did utilize a 3 + 3 design to identify the maximum tolerated dose (MTD) or a Pharmacologically Active Dose (PAD) of the combination. This was followed by a dose expansion phase, which was comprised of three cohorts. Expansion Cohorts 1 \& 2 will further evaluate the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics at the dose identified in phase one. Expansion Cohort 3 will evaluate the change in biomarker expression following treatment with epacadostat as monotherapy followed by epacadostat and atezolizumab administered in combination.

Being tested
Epacadostat, Atezolizumab
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.

  • EpacadostatDrug

    Also called INCB024360

    Epacadostat tablets

  • AtezolizumabDrug

    Also called MPDL3280A

    Atezolizumab intravenously

Study groups in NCT02298153
Study groupRoleWhat they receive
Epacadostat 25 mg+Atezolizumab 1200 mgExperimentalEpacadostat 25 mg tablet orally twice daily (BID) starting on Cycle 1 Day 1 in combination with atezolizumab 1200 mg administered intravenously every 3 weeks starting on Cycle 1 Day 1.
Receives: Drug: Epacadostat; Drug: Atezolizumab
Epacadostat 50 mg+Atezolizumab 1200 mgExperimentalEpacadostat 50 mg tablet orally BID starting on Cycle 1 Day 1 in combination with atezolizumab 1200 mg administered intravenously every 3 weeks starting on Cycle 1 Day 1.
Receives: Drug: Epacadostat; Drug: Atezolizumab
Epacadostat 75 mg+Atezolizumab 1200 mgExperimentalEpacadostat 75 mg tablet orally BID starting on Cycle 1 Day 1 in combination with atezolizumab 1200 mg administered intravenously every 3 weeks starting on Cycle 1 Day 1.
Receives: Drug: Epacadostat; Drug: Atezolizumab
Epacadostat 100 mg+Atezolizumab 1200 mgExperimentalEpacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with atezolizumab 1200 mg administered intravenously every 3 weeks starting on Cycle 1 Day 1.
Receives: Drug: Epacadostat; Drug: Atezolizumab
Epacadostat 200 mg+Atezolizumab 1200 mgExperimentalEpacadostat 200 mg tablet orally BID starting on Cycle 1 Day 1 in combination with atezolizumab 1200 mg administered intravenously every 3 weeks starting on Cycle 1 Day 1.
Receives: Drug: Epacadostat; Drug: Atezolizumab
Epacadostat 300 mg+Atezolizumab 1200 mgExperimentalEpacadostat 300 mg tablet orally BID starting on Cycle 1 Day 1 in combination with atezolizumab 1200 mg administered intravenously every 3 weeks starting on Cycle 1 Day 1.
Receives: Drug: Epacadostat; Drug: Atezolizumab

What is being measured

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

  1. Incidence of adverse events (AEs)

    Measured: Continuously for duration of study participation and up to 42 days after the last dose [approximately 8 months

  2. Incidence of dose-limiting toxicities (DLTs)

    Measured: 21 days following the first administration of atezolizumab and epacadostat

Secondary outcomes (4)

  1. Objective response rate (ORR)

    ORR determined by radiographic disease assessments per modified RECIST v1.1

    Measured: Measured every 6 weeks for duration of study participation [approximately 8 months]

  2. Durability of response

    Time from the earliest date of disease response until earliest date of disease progression based on modified RECIST v1.1

    Measured: Measured every 6 weeks for duration of study participation [approximately 8 months]

  3. Progression-free survival

    Time from date of enrollment until the earliest date of disease progression per modified RECIST v1.1 or death due to any cause, whichever is earlier.

    Measured: Measured every 6 weeks for duration of study participation [approximately 8 months]

  4. Duration of disease control

    Time from first dose until report of disease progression for subjects who reported stable disease or better based on modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Measured: Measured every 6 weeks for duration of study participation [approximately 8 months]

Timeline

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

  1. First posted21 Nov 2014 (estimated)
  2. Study start27 Jan 2015
  3. Primary completion8 Nov 2017
  4. Study completion8 Nov 2017

Why it stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.

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
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02298153
Sponsor's protocol ID
INCB 24360-110
Other IDs
ECHO-110
Status last verified
Apr 2026
First submitted
31 Oct 2014
Last updated
20 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Epacadostat and Atezolizumab in people with NSCLC (Non-small Cell Lung Carcinoma) and UC (Urothelial Cancer), run by Incyte Corporation at 6 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 13 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 20 Apr 2026. 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 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 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?

The study was stopped early (reason given: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.). 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?

Incidence of adverse events (AEs) (time frame: Continuously for duration of study participation and up to 42 days after the last dose [approximately 8 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?

On the ClinicalTrials.gov record for NCT02298153.

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 20 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in