Carcinoma, Non-Small-Cell LungPhase 2NCT02343952
Consolidation Pembrolizumab Following Chemoradiation in Patients With Inoperable/Unresectable Stage III NSCLC
A Phase 2 study testing Pembrolizumab in people with Carcinoma, Non-Small-Cell Lung, run by Nasser Hanna, M.D. at 15 sites in United States.
Trial summary
This is an open label, multi-institutional, single arm phase II trial of consolidation therapy with pembrolizumab, following initial treatment with concurrent chemoradiation in patients with inoperable or unresectable stage IIIA or IIIB NSCLC. No randomization or blinding is involved. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 15 sitesUnited States
- Study dates
- 9 Mar 2015to 1 Jan 2021
- Phase
- Phase 2
- 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
- Histological or cytological evidence of NSCLC
- Must have unresectable or inoperable stage IIIA or IIIB disease. Patients are considered unresectable or inoperable based on the judgment of the treating physician
- Must have completed concurrent chemoradiation with a standard chemotherapy regimen (either cisplatin/etoposide or carboplatin/paclitaxel) and a dose of radiation ranging from 59.4-66.6Gy
- Must have stable disease or disease response as evidenced on CT evaluation a minimum of 28 days and a maximum of 56 days following the completion of chemoradiation
- Women of childbearing potential must be willing to use two methods of contraception or abstain from heterosexual activity from the point of registration through 120 days after the last dose of study drug
- Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of the study drug through 120 days after the last dose of the study drug
- Age ≥ 18 years at the time of consent
- Written informed consent and HIPAA authorization for release of personal health information
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
- Active central nervous system (CNS) metastases. Subjects must undergo a head computed tomography (CT) scan or brain MRI within 28 days prior to registration for protocol therapy to exclude brain metastases if symptomatic or without prior brain imaging
- Treatment with any investigational agent within 28 days prior to registration for protocol therapy
- Prior chemotherapy, adjuvant therapy, or radiotherapy for lung cancer, other than standard concurrent chemoradiation as described above
- Prior therapy with a PD-1, PD-L1, or CTLA-4 inhibitor or a lung cancer-specific vaccine therapy
- Presence of metastatic disease (stage IV NSCLC) is not allowed. Subjects must be evaluated with a PET scan within 28 days prior to registration for protocol therapy to exclude metastatic disease
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- No active second cancers
- Evidence of active autoimmune disease requiring systemic treatment within the past 90 days or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study
- Interstitial lung disease or history of pneumonitis requiring treatment with corticosteroids
- Diagnosis of immunodeficiency or is receiving chronic systemic corticosteroid therapy or other immunosuppressive therapy (excludes inhaled corticosteroids) within 7 days of first dose of study drug
- History of psychiatric illness or social situations that would limit compliance with study requirements
- Clinically active infection as judged by the treating investigator (≥ Grade 2 by CTCAE v4) including known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
University of Virginia Health System
Charlottesville, Virginia, 22908
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Fort Wayne Oncology & Hematology, Inc.
Fort Wayne, Indiana, 46845
IU Health Goshen Hospital
Goshen, Indiana, 46527
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
IU Health Central Indiana Cancer Centers
Indianapolis, Indiana, 46219
Community Regional Cancer Care
Indianapolis, Indiana, 49256
IU Health Arnett Cancer Center
Lafayette, Indiana, 47904
Horizon Oncology Research, Inc.
Lafayette, Indiana, 47905
University of Louisville, James Graham Brown Cancer Center
Louisville, Kentucky, 40202
IU Health at Ball Memorial Hospital
Muncie, Indiana, 47303
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Oncology Hematology Associates of SW Indiana
Newburgh, Indiana, 47630
Nebraska Cancer Specialists
Omaha, Nebraska, 68114
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601
About this study
Official title: A Phase II Trial of Concurrent Chemoradiation With Consolidation Pembrolizumab for the Treatment of Inoperable or Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC): HCRN LUN14-179
This is an open label, multi-institutional, single arm phase II trial of consolidation therapy with pembrolizumab, following initial treatment with concurrent chemoradiation in patients with inoperable or unresectable stage IIIA or IIIB NSCLC. No randomization or blinding is involved.
Read the detailed description
OUTLINE: This is a multi-center study.
Eligible patients must have completed concurrent chemoradiation with a standard chemotherapy regimen (either cisplatin/etoposide or carboplatin/paclitaxel) and a dose of radiation ranging from 59.4-66.6Gy, with restaging completed 28 days to 56 days post-chemoradiation. Patients with progressive disease will not be eligible for investigational treatment. Patients with stable disease/response will be eligible to register for investigational treatment of consolidation therapy to begin a minimum of 28 days and a maximum of 56 days from completion of chemoradiotherapy.
INVESTIGATIONAL TREATMENT:
Pembrolizumab, 200 mg IV every 3 weeks (until progressive disease (PD), unacceptable toxicity, or after 12 months (52 weeks) of therapy with pembrolizumab.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Hematopoietic:
- Absolute neutrophil count (ANC) ≥1,500/mcL
- Platelets ≥100,000/mcL
- Hemoglobin ≥9 g/dL or ≥5.6 mmol/L
Renal:
- Serum creatinine OR measured or calculated creatinine clearance ≤1.5 X institutional upper limit of normal (ULN) OR ≥60 mL/min for subject with creatinine levels > 1.5 X institutional ULN (glomerular filtration rate (GFR) can also be used in place of creatinine or CrCl)
Hepatic:
- Serum total bilirubin ≤ 1.5 X institutional ULN OR direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 institutional ULN
- Aspartate transaminase (AST), serum glutamic oxaloacetic transaminase (SGOT), alanine transaminase (ALT), serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 X institutional ULN
Coagulation:
- International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X institutional ULN unless subject is receiving anticoagulant therapy as long as PT/INR/PTT is within therapeutic range of intended use of anticoagulants.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Pembrolizumab
- Keywords
- Pembrolizumab, MK-3475
- 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.
PembrolizumabDrug
Also called MK-3475
Pembrolizumab, 200 mg IV every 3 weeks (until PD, unacceptable toxicity, or after 12 months of therapy with pembrolizumab.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Pembrolizumab -200 mg IV 3 weeks Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Death or Distant Metastasis
Time to Death or Distant Metastasis is defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis. Distant metastasis is defined as any new lesion that was outside of the radiation field according to RECIST 1.1 or proven by biopsy. The Primary objective in the study was to determine if consolidation therapy with pembrolizumab following concurrent chemoradiation improves time to death or distant metastatic disease, depending on which occurs first, in subjects with inoperable or unresectable stage IIIA or IIIB NSCLC.
Measured: From start of treatment until death or distant metastasis (estimate 18 months) up to a maximum of 47 months.
Secondary outcomes (3)
Progression Free Survival
Progression Free Survival is defined as the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression). Progression is defined using RECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. One of the secondary objectives in the study is to determine if consolidation therapy with pembrolizumab following concurrent chemoradiation improves progression free survival in subjects with inoperable or unresectable stage IIA or IIIB non-small cell lung cancer(NSCLC). PFS has been estimated by Kaplan-Meier method.
Measured: From start of treatment until Progression based on RECIST 1.1 or death up to a maximum value of 47 months
Overall Survival
Overall Survival is defined as the time from the date of randomization until death due to any cause. One of the secondary objectives in the study is to determine if consolidation therapy with pembrolizumab following concurrent chemoradiation improves Overall Survival in subjects with inoperable or unresectable stage IIA or IIIB non-small cell lung cancer(NSCLC). OS has been estimated by Kaplan-Meier method.
Measured: From the date of randomization up to a maximum value of 47 months or death.
Number of Participants Experiencing Grade 3-4 AE With Adverse Events as a Measure of Safety and Tolerability
One of the secondary objective in this study is to assess toxicity and tolerability of pembrolizumab consolidation therapy following concurrent chemoradiation in subjects with stage IIIA or IIIB NSCLC.
Measured: From the time of consent until 30 days after last dose of pembrolizumab up to a maximumof 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2015 (estimated)
- Study start9 Mar 2015
- Primary completion10 Aug 2020
- Study completion1 Jan 2021
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 Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nasser Hanna, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Hoosier Cancer Research Network
- Responsible party
- Sponsor-investigator, Nasser Hanna, M.D., Hoosier Cancer Research Network
- Investigators
- Nasser Hanna, M.D., Study chair, Hoosier Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02343952
- Sponsor's protocol ID
- HCRN LUN14-179
- Status last verified
- Aug 2023
- First submitted
- 6 Jan 2015
- Last updated
- 13 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Concurrent Chemoradiation With Consolidation Pembrolizumab for the Treatment of Inoperable or Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC): HCRN LUN14-179
- ClinicalTrials.gov ID
- NCT02343952
- Acronym / sponsor ID
- HCRN LUN14-179
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Pembrolizumab, MK-3475
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Nasser Hanna, M.D.University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Hoosier Cancer Research Network
- Study start
- 9 Mar 2015 (actual)
- Primary completion
- 10 Aug 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 22 Jan 2015 (estimated)
- Results
- Posted 6 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label, multi-institutional, single arm phase II trial of consolidation therapy with pembrolizumab, following initial treatment with concurrent chemoradiation in patients with inoperable or unresectable stage IIIA or IIIB NSCLC. No randomization or blinding is involved.
Detailed description
OUTLINE: This is a multi-center study.
Eligible patients must have completed concurrent chemoradiation with a standard chemotherapy regimen (either cisplatin/etoposide or carboplatin/paclitaxel) and a dose of radiation ranging from 59.4-66.6Gy, with restaging completed 28 days to 56 days post-chemoradiation. Patients with progressive disease will not be eligible for investigational treatment. Patients with stable disease/response will be eligible to register for investigational treatment of consolidation therapy to begin a minimum of 28 days and a maximum of 56 days from completion of chemoradiotherapy.
INVESTIGATIONAL TREATMENT:
Pembrolizumab, 200 mg IV every 3 weeks (until progressive disease (PD), unacceptable toxicity, or after 12 months (52 weeks) of therapy with pembrolizumab.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Hematopoietic:
- Absolute neutrophil count (ANC) ≥1,500/mcL
- Platelets ≥100,000/mcL
- Hemoglobin ≥9 g/dL or ≥5.6 mmol/L
Renal:
- Serum creatinine OR measured or calculated creatinine clearance ≤1.5 X institutional upper limit of normal (ULN) OR ≥60 mL/min for subject with creatinine levels > 1.5 X institutional ULN (glomerular filtration rate (GFR) can also be used in place of creatinine or CrCl)
Hepatic:
- Serum total bilirubin ≤ 1.5 X institutional ULN OR direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 institutional ULN
- Aspartate transaminase (AST), serum glutamic oxaloacetic transaminase (SGOT), alanine transaminase (ALT), serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 X institutional ULN
Coagulation:
- International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X institutional ULN unless subject is receiving anticoagulant therapy as long as PT/INR/PTT is within therapeutic range of intended use of anticoagulants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: PembrolizumabPembrolizumab -200 mg IV 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histological or cytological evidence of NSCLC
- Must have unresectable or inoperable stage IIIA or IIIB disease. Patients are considered unresectable or inoperable based on the judgment of the treating physician
- Must have completed concurrent chemoradiation with a standard chemotherapy regimen (either cisplatin/etoposide or carboplatin/paclitaxel) and a dose of radiation ranging from 59.4-66.6Gy
- Must have stable disease or disease response as evidenced on CT evaluation a minimum of 28 days and a maximum of 56 days following the completion of chemoradiation
- Women of childbearing potential must be willing to use two methods of contraception or abstain from heterosexual activity from the point of registration through 120 days after the last dose of study drug
Key exclusion criteria (13 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
- Active central nervous system (CNS) metastases. Subjects must undergo a head computed tomography (CT) scan or brain MRI within 28 days prior to registration for protocol therapy to exclude brain metastases if symptomatic or without prior brain imaging
- Treatment with any investigational agent within 28 days prior to registration for protocol therapy
- Prior chemotherapy, adjuvant therapy, or radiotherapy for lung cancer, other than standard concurrent chemoradiation as described above
- Prior therapy with a PD-1, PD-L1, or CTLA-4 inhibitor or a lung cancer-specific vaccine therapy
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 |
|---|---|---|
| PembrolizumabAlso: MK-3475Pembrolizumab, 200 mg IV every 3 weeks (until PD, unacceptable toxicity, or after 12 months of therapy with pembrolizumab. | Drug | Experimental Arm |
Primary outcome
Time to Death or Distant Metastasis
Time frame: From start of treatment until death or distant metastasis (estimate 18 months) up to a maximum of 47 months.
Time to Death or Distant Metastasis is defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis. Distant metastasis is defined as any new lesion that was outside of the radiation field according to RECIST 1.1 or proven by biopsy. The Primary objective in the study was to determine if consolidation therapy with pembrolizumab following concurrent chemoradiation improves time to death or distant metastatic disease, depending on which occurs first, in subjects with inoperable or unresectable stage IIIA or IIIB NSCLC.
3 secondary outcomes
Progression Free Survival
Time frame: From start of treatment until Progression based on RECIST 1.1 or death up to a maximum value of 47 months
Overall Survival
Time frame: From the date of randomization up to a maximum value of 47 months or death.
Number of Participants Experiencing Grade 3-4 AE With Adverse Events as a Measure of Safety and Tolerability
Time frame: From the time of consent until 30 days after last dose of pembrolizumab up to a maximumof 18 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Hoosier Cancer Research Network WebsiteLink provided by the sponsor.
- 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.
Nasser Hanna, M.D. study chair
Hoosier Cancer Research Network
15 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 Pembrolizumab in people with Carcinoma, Non-Small-Cell Lung, run by Nasser Hanna, M.D. at 15 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 8 inclusion and 13 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: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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 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?
Yes. Results are posted in the registry (first posted 6 Jan 2022). 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?
Time to Death or Distant Metastasis (time frame: From start of treatment until death or distant metastasis (estimate 18 months) up to a maximum of 47 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 13 Sep 2023.