Non-Small-Cell Lung CancerPhase 2NCT03083808
Phase II Trial of Continuation Therapy in Advanced NSCLC
A Phase 2 study testing Pembrolizumab in people with Non-Small-Cell Lung Cancer, run by Greg Durm, MD at 5 sites in United States.
Trial summary
This is a single-arm phase II study of continuation immunotherapy with pembrolizumab following initial benefit (CR, PR, or SD ≥ 3 months) with a PD-1 or PD-L1 inhibitor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small-Cell Lung Cancer
- 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
- 35 participants
- Where
- 5 sitesUnited States
- Study dates
- 20 Mar 2017to 3 Mar 2022
- 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
- Subjects must meet all of the following applicable inclusion criteria to participate in this study:
- Written informed consent and HIPAA authorization for release of protected health information.
- Age ≥ 18 years at the time of consent.
- Histological or cytological evidence of stage IV NSCLC (any histology)
- Subjects must have progressed on or after previous platinum-based chemotherapy. Chemotherapy may have previously been given with a PD-1 or PD-L1 inhibitor. Subjects must have also progressed on or after receiving any PD-1 or PD-L1 inhibitor (including pembrolizumab) as their most recent therapy and must have had at least a 3-month PFS on this therapy.
- Subjects must be enrolled on the trial within 6 weeks of their last infusion of PD-1 or PD-L1 inhibitor therapy.
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- Subjects whose tumors harbor a mutation in EGFR exon 19 or 21 or have gene rearrangements in ALK or ROS1 must have already been treated with standard targeted therapies. NOTE: Subjects must also have progressed on or after platinum-containing combination chemotherapy.
- ECOG Performance Status of 0 or 1 within 28 days prior to registration for protocol therapy.
- Must be fit enough to receive next-line chemotherapy (either gemcitabine, docetaxel, or pemetrexed [non-squamous only]) according to the discretion of the treating physician.
- Adequate laboratory values obtained within 28 days prior to registration for protocol therapy.
- Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test within 7 days prior to study registration and/or within 72 hours of first dose of study drugs. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- 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 capable of fathering a child 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.
Who cannot join
- Subjects meeting any of the criteria below may not participate in the study:
- 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. NOTE: Subjects who are symptomatic or have not undergone prior brain imaging must undergo a head computed tomography (CT) scan or brain MRI within 28 days prior to registration to exclude brain metastases.
- Treatment with any investigational agent within 28 days prior to registration for protocol therapy with the exception of PD-1 or PD-L1 inhibitors.
- No active second cancers with the exception of localized non-melanoma skin cancer, in-situ cervical or in-situ bladder cancer.
- 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.
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- History of (non-infectious) pneumonitis requiring treatment with corticosteroids, evidence of interstitial lung disease or active, non-infectious pneumonitis.
- History of an immune-related toxicity requiring treatment with corticosteroids during prior PD-1/ PD-L1 inhibitor treatment.
- Diagnosis of immunodeficiency or is receiving chronic systemic corticosteroid therapy or other immunosuppressive therapy (excludes inhaled corticosteroids) within 7 days of study registration.
- History of psychiatric illness or social situations that would limit compliance with study requirements.
- Clinically active infection (≥ Grade 2) as judged by the site investigator.
- Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C. NOTE: HIV, HBV or HCV testing is not required.
- 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 site investigator.
- Known history of active TB (Bacillus Tuberculosis).
- History of hypersensitivity to pembrolizumab, docetaxel, gemcitabine, pemetrexed or any of their excipients.
- Has received a live vaccine within 30 days prior to planned start of study therapy.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Illinois Cancer Center
Chicago, Illinois, 60612
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
University of Iowa Hospital Clinics
Iowa City, Iowa, 52242
University of Wisconsin
Madison, Wisconsin, 53705
University of Minnesota Medcical Center
Minneapolis, Minnesota, 55455
About this study
Official title: A Phase II Trial of Chemotherapy Plus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Previously Treated With PD-1 or PD-L1 Inhibitor: Big Ten Cancer Research Consortium BTCRC-LUN15-029
This is a single-arm phase II study of continuation immunotherapy with pembrolizumab following initial benefit (CR, PR, or SD ≥ 3 months) with a PD-1 or PD-L1 inhibitor.
Read the detailed description
OUTLINE: This is a multi-center study.
Patients who have been treated with a PD-1 or PD-L1 inhibitor and experienced a PFS of ≥3 months will be enrolled within 6 weeks of last dose of PD-1 or PD-L1 inhibitor. On Day 1 of each 3-week cycle, subjects will first receive pembrolizumab at a dose of 200mg IV every three weeks in combination with chemotherapy. Partner chemotherapy will be either gemcitabine 1000mg/m2 IV D1 and D8 every three weeks, docetaxel 75mg/m2 IV D1 every three weeks, or pemetrexed 500mg/m2 IV D1 every 3 weeks (pemetrexed for non-squamous histologies only). Subjects will continue to receive this combination until progression or intolerable toxicity.
Administration Sequence: First Sequence
- Pembrolizumab 200mg IV on Day 1 (cycle = 21 days)
Administration Sequence: Second Sequence
- Gemcitabine 1000mg/m^2 IV on Days 1,8 (cycle = 21 days)
- Docetaxel 75mg/^2 IV on Days 1,8 (cycle = 21 days)
- Pemetrexed 500mg/m^2 IV on Day 1 (cycle -= 21 days)
- Conditions
- Non-Small-Cell Lung Cancer
- Being tested
- Pembrolizumab
- Keywords
- PD-1, PD-L1 Inhibitor, Pembrolizumab, Docetaxel, Pemetrexed, Gemcitabine
- 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 Keytruda®, MK-3475
Pembrolizumab 200mg IV every 21 days
+
Physician's choice chemotherapy with one of the following every 21 days:
- Docetaxel 75mg/m2 IV
- Pemetrexed 500mg/m2 IV (non-squamous only)
- Gemcitabine 1000mg/m2 IV on days 1 and 8
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab 200mg IV every 21 days | Experimental | Patients who have been treated with a PD-1 or PD-L1 inhibitor and experienced a PFS of ≥3 months will be enrolled within 6 weeks of last dose of PD-1 or PD-L1 inhibitor. On Day 1 of each 3-week cycle, subjects will first receive pembrolizumab at a dose of 200mg IV every three weeks in combination with chemotherapy. Partner chemotherapy will be either gemcitabine 1000mg/m^2 IV D1 and D8 every three weeks, docetaxel 75mg/m^2 IV D1 every three weeks, or pemetrexed 500mg/m^2 IV D1 every 3 weeks (pemetrexed for non-squamous histologies only). Subjects will continue to receive this combination until progression or intolerable toxicity. Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter(LD) of target lesions; Progressive Disease (PD): >= 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
PFS was defined as time from starting treatment to disease progression met by RECIST 1.1, start of additional anticancer therapy before progression, or death from any cause.
Measured: Time of treatment start until the criteria for disease progression or death, up to a maximum of 28 months
Secondary outcomes (5)
Clinical Benefit Rate (CBR)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter(LD) of target lesions; Progressive Disease (PD) >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD.
Per Immune-Related RECIST (irRECIST): Complete Response(irCR), Disappearance of all measurable and non-measurable lesions; Partial Response (irPR) >=30% decrease in tumor burden relative to baseline; Progressive Disease (irPD), >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions confirmed by a consecutive assessment at least 4 week after first documentation; Stable Disease (irSD), not meeting criteria for irCR or irPR, in absence of irPD CBR is defined as any subject with SD for ≥ 3 months, PR or CR assessed via RECIST 1.1 and irRECIST.
Measured: Up to a maximum of 28 months
Objective Response Rate (ORR)
Per RECIST: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter(LD) of target lesions; Progressive Disease (PD) >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD.
Per irRECIST: Complete Response(irCR), Disappearance of all measurable and non-measurable lesions; Partial Response (irPR) >=30% decrease in tumor burden relative to baseline; Progressive Disease (irPD), >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions confirmed by a consecutive assessment at least 4 week after first documentation; Stable Disease (irSD), not meeting criteria for irCR or irPR, in absence of irPD ORR is defined as the proportion of all subjects with confirmed PR or CR according to RECIST 1.1 and irRECIST, from the start of treatment until disease progression/recurrence
Measured: Up to a maximum of 28 months
Overall Survival (OS)
Time from date of treatment start to date of death from any cause
Measured: Time of treatment start until death or up to a maximum of 40 months
Number of Participants With Adverse Events
Toxicity will be graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events version 4
Measured: Adverse events were recorded from time of registration until 30 days after discontinuation of study drug(s) up to a maximum of 25 months.
Progression Free Survival (PFS) by irRECIST
Per Immune-Related RECIST (irRECIST): Complete Response(irCR), Disappearance of all measurable and non-measurable lesions; Partial Reponse (irPR): >=30% decrease in in tumor burden relative to baseline; Progressive Disease (irPD), >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions confirmed by a consecutive assessment at least 4 week after first documentation; Stable Disease (irSD), not meeting criteria for irCR or irPR, in absence of irPD.
PFS is defined as time from the date of treatment start until the criteria for disease progression is met as defined by irRECIST or death occurs.
Measured: Time of treatment start until the criteria for disease progression or death, up to a maximum of 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study start20 Mar 2017
- Primary completion14 Dec 2021
- Study completion3 Mar 2022
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 Non-Small-Cell Lung CancerStudies 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Greg Durm, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Big Ten Cancer Research Consortium
- Responsible party
- Sponsor-investigator, Greg Durm, MD, Big Ten Cancer Research Consortium
- Investigators
- Greg Durm, M.D., Study chair, Big Ten Cancer Research Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083808
- Sponsor's protocol ID
- BTCRC-LUN15-029
- Status last verified
- Aug 2023
- First submitted
- 14 Mar 2017
- Last updated
- 24 Aug 2023
- 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 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Chemotherapy Plus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Previously Treated With PD-1 or PD-L1 Inhibitor: Big Ten Cancer Research Consortium BTCRC-LUN15-029
- ClinicalTrials.gov ID
- NCT03083808
- Acronym / sponsor ID
- BTCRC-LUN15-029
- Conditions
- Non-Small-Cell Lung Cancer
- Keywords
- PD-1, PD-L1 Inhibitor, Pembrolizumab, Docetaxel, Pemetrexed, Gemcitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Greg Durm, MDUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Big Ten Cancer Research Consortium
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 14 Dec 2021 (actual)
- Study completion
- 3 Mar 2022 (actual)
- First posted
- 20 Mar 2017 (actual)
- Results
- Posted 28 Jun 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 a single-arm phase II study of continuation immunotherapy with pembrolizumab following initial benefit (CR, PR, or SD ≥ 3 months) with a PD-1 or PD-L1 inhibitor.
Detailed description
OUTLINE: This is a multi-center study.
Patients who have been treated with a PD-1 or PD-L1 inhibitor and experienced a PFS of ≥3 months will be enrolled within 6 weeks of last dose of PD-1 or PD-L1 inhibitor. On Day 1 of each 3-week cycle, subjects will first receive pembrolizumab at a dose of 200mg IV every three weeks in combination with chemotherapy. Partner chemotherapy will be either gemcitabine 1000mg/m2 IV D1 and D8 every three weeks, docetaxel 75mg/m2 IV D1 every three weeks, or pemetrexed 500mg/m2 IV D1 every 3 weeks (pemetrexed for non-squamous histologies only). Subjects will continue to receive this combination until progression or intolerable toxicity.
Administration Sequence: First Sequence
- Pembrolizumab 200mg IV on Day 1 (cycle = 21 days)
Administration Sequence: Second Sequence
- Gemcitabine 1000mg/m^2 IV on Days 1,8 (cycle = 21 days)
- Docetaxel 75mg/^2 IV on Days 1,8 (cycle = 21 days)
- Pemetrexed 500mg/m^2 IV on Day 1 (cycle -= 21 days)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab 200mg IV every 21 days | Experimental | Drug: PembrolizumabPatients who have been treated with a PD-1 or PD-L1 inhibitor and experienced a PFS of ≥3 months will be enrolled within 6 weeks of last dose of PD-1 or PD-L1 inhibitor. On Day 1 of each 3-week cycle, subjects will first receive pembrolizumab at a dose of 200mg IV every three weeks in combination with chemotherapy. Partner chemotherapy will be either gemcitabine 1000mg/m^2 IV D1 and D8 every three weeks, docetaxel 75mg/m^2 IV D1 every three weeks, or pemetrexed 500mg/m^2 IV D1 every 3 weeks (pemetrexed for non-squamous histologies only). Subjects will continue to receive this combination until progression or intolerable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects must meet all of the following applicable inclusion criteria to participate in this study:
- Written informed consent and HIPAA authorization for release of protected health information.
- Age ≥ 18 years at the time of consent.
- Histological or cytological evidence of stage IV NSCLC (any histology)
- Subjects must have progressed on or after previous platinum-based chemotherapy. Chemotherapy may have previously been given with a PD-1 or PD-L1 inhibitor. Subjects must have also progressed on or after receiving any PD-1 or PD-L1 inhibitor (including pembrolizumab) as their most recent therapy and must have had at least a 3-month PFS on this therapy.
Key exclusion criteria (16 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. NOTE: Subjects who are symptomatic or have not undergone prior brain imaging must undergo a head computed tomography (CT) scan or brain MRI within 28 days prior to registration to exclude brain metastases.
- Treatment with any investigational agent within 28 days prior to registration for protocol therapy with the exception of PD-1 or PD-L1 inhibitors.
- No active second cancers with the exception of localized non-melanoma skin cancer, in-situ cervical or in-situ bladder cancer.
- 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.
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: Keytruda®, MK-3475Pembrolizumab 200mg IV every 21 days + Physician's choice chemotherapy with one of the following every 21 days: * Docetaxel 75mg/m2 IV * Pemetrexed 500mg/m2 IV (non-squamous only) * Gemcitabine 1000mg/m2 IV on days 1 and 8 | Drug | Pembrolizumab 200mg IV every 21 days |
Primary outcome
Progression Free Survival (PFS)
Time frame: Time of treatment start until the criteria for disease progression or death, up to a maximum of 28 months
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter(LD) of target lesions; Progressive Disease (PD): >= 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. PFS was defined as time from starting treatment to disease progression met by RECIST 1.1, start of additional anticancer therapy before progression, or death from any cause.
5 secondary outcomes
Clinical Benefit Rate (CBR)
Time frame: Up to a maximum of 28 months
Objective Response Rate (ORR)
Time frame: Up to a maximum of 28 months
Overall Survival (OS)
Time frame: Time of treatment start until death or up to a maximum of 40 months
Number of Participants With Adverse Events
Time frame: Adverse events were recorded from time of registration until 30 days after discontinuation of study drug(s) up to a maximum of 25 months.
Progression Free Survival (PFS) by irRECIST
Time frame: Time of treatment start until the criteria for disease progression or death, up to a maximum of 28 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Big Ten Cancer Research Consortium 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.
Greg Durm, M.D. study chair
Big Ten Cancer Research Consortium
5 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 Non-Small-Cell Lung Cancer, run by Greg Durm, MD at 5 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 16 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 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 28 Jun 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?
Progression Free Survival (PFS) (time frame: Time of treatment start until the criteria for disease progression or death, up to a maximum of 28 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 Aug 2023.