Non Small Cell Lung CancerPhase 2NCT02684461
Phase II Trial of Sequential Consolidation With Pembrolizumab Followed by Nab-paclitaxel
A Phase 2 study testing Pembrolizumab in people with Non Small Cell Lung Cancer, run by UNC Lineberger Comprehensive Cancer Center at 5 sites in United States.
Trial summary
The purpose of this research study is to test the effectiveness of three treatment arms that are designed to improve survival in patients with non-small cell lung cancer. Eligible subjects could be randomized to four (4) cycles of chemotherapy followed by immunotherapy, or immunotherapy followed by chemotherapy, or… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 5 sitesUnited States
- Study dates
- 13 Sep 2016to 19 Nov 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be willing and able to provide written informed consent for this trial
- Be greater than or equal to 18 years of age on day of signing consent
- Eastern Cooperative Oncology Group Performance Status less than or equal to 1
- Histologically or cytologically confirmed confirmed stage IV (metastatic) non small cell lung cancer as defined by American Joint Committee on Cancer (AJCC). Recurrent but not metastatic disease is allowed if deemed incurable.
- Has completed or scheduled to begin 4-6 cycles of platinum based induction chemotherapy that does not include a taxane
- Induction may contain, but is not require to contain bevacizumab or cetuximab.
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- Induction with a platinum doublet plus another biologic agent will be allowed following review by the University of North Carolina principal investigator that thee is no additional risk to the subject
- NOTE: Evaluable disease is not required for study entry (patients with complete response or response sufficient to preclude measurable lesions are not excluded; such patients will be evaluated for progression free survival and overall survival, but not response)
- Demonstrate adequate organ function (defined in protocol). All screening labs should be performed within 14 days of treatment initiation.
- Recovered from all reversible toxicities related to their previous treatment (other than alopecia) less than or equal to grade 1 or baseline; exceptions to this criteria may be allowed at the discretion of the overall principal investigator for toxicities that are not expected to be exacerbated by pembrolizumab or nab paclitaxel
- Patients with brain metastases may participate if they have undergone appropriate treatment for the lesion)s), are at least two weeks post treatment without evidence for post-treatment progression, have no significant neurologic symptoms, and no longer require steroids for the reason of brain metastases
- Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for greater than 1 year. The two birth control methods can be two barrier methods or a barrier method plus a hormonal method to prevent pregnancy. Subjects should start using birth control from study Visit 1 throughout the study period up to 120 days after the last dose of study therapy.
- Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
Who cannot join
- Patients with epidermal growth factor receptor (EGFR) mutations expected to be sensitive to epidermal growth factor receptor (EGFR) inhibitors and patients with Echinoderm Microtubule-Associated Protein like 4 anaplastic lymphoma kinase (EML4/ALK) translocations are excluded, unless all available FDA approved targeted therapy options have been utilized. NOTE: In contrast to the above a patient with an EGFR mutation who has been treated with a first-generation and third generation TKIs and then with four cycles of carboplatin plus pemetrexed would be eligible
- Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose treatment
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1. Note: if subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
- Has had a prior monoclonal antibody within 4 weeks prior to study day 1 or who has not recovered from adverse events due to agents administered more than 4 weeks earlier. Exceptions to these criteria may be allowed at the discretion overall principal for toxicities that are not expected to be exacerbated by pembrolizumab or nab-paclitaxel
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy
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- Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; 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 Sjorgen's syndrome will not be excluded from the study
- Has evidence of interstitial lung disease or active, non-infectious pneumonitis
- Has an active infection requiring systemic therapy
- 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
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
- Has inadequate home environment or social support to safely complete the trial procedures
- Is 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
- Has received prior therapy with an anti-programmed cell death-1 (PD-1) , anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- Known hypersensitivity to protein bound paclitaxel
- Has received prior therapy with any taxane chemotherapy
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
- Has known active Hepatitis B or Hepatitis C
- Has received a live vaccine within 30 days prior to the first dose of trial treatment
- Has a history of non-infectious pneumonitis that required steroids or evidence of interstitial lung disease or current active, non-infectious pneumonitis
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
UNC Lineberger Comprehsive Cancer Center
Chapel Hill, North Carolina, 27599
UT Southwestern Medical Center
Dallas, Texas, 75390
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Rex Cancer Center
Raleigh, North Carolina, 27607
Rex Cancer Center of Wakefield
Raleigh, North Carolina, 27614
About this study
Official title: Phase II Trial of Sequential Consolidation With Pembrolizumab Followed by Nab-paclitaxel After Standard First-Line Induction Chemotherapy in Advanced NSCLC
The purpose of this research study is to test the effectiveness of three treatment arms that are designed to improve survival in patients with non-small cell lung cancer. Eligible subjects could be randomized to four (4) cycles of chemotherapy followed by immunotherapy, or immunotherapy followed by chemotherapy, or four cycles of chemotherapy plus immunotherapy.
Read the detailed description
This open-label, three-arm, non-comparative randomized phase II study is designed to evaluate three different sequences of double-consolidation with the humanized monoclonal antibody targeted against cell surface receptor programmed cell death-1 (PD-1), pembrolizumab, and nab-paclitaxel in patients with advanced Non small cell lung cancer post induction chemotherapy. While the goal of each arm is to guarantee exposure to each of these two agents to patients who have not progressed post induction chemotherapy, they do so with different sequence. In ARMs A and B, consolidation is sequential, with either pembrolizumab followed by nab-paclitaxel (ARM A), or nab-paclitaxel followed by pembrolizumab (ARM B). In ARM C, consolidation is concurrent, with the two agents administered concurrently. As of July 24, ARMs B and C are closed, and no patients will be enrolled on this study. ARM A remains open to enrollment.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Pembrolizumab
- Keywords
- lung cancer, PD-1 antibody, immune checkpoint blockade
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Keytruda, nab-paclitaxel
Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Sequential Consolidation | Active comparator | Completion of four cycles of Sequential Consolidation of Pembrolizumab 200mg every 21 days and then four cycles Nab-paclitaxel 100 mg/mg2 on day 1 and day 8 every 21 days Receives: Drug: Pembrolizumab |
| Arm B: Sequential Consolidation | Active comparator | Completion of 4 cycles of Sequential Consolidation of Nab-paclitexel 100 mg/m2 on day 1 and day 8 every 21 days and then Pembrolizumab 200 mg every 21 Receives: Drug: Pembrolizumab |
| Arm C: Concurrent Consolidation | Active comparator | Concurrent Consolidation of Nab paclitaxel 100 mg/m2 on day 1 and day 8 plus Pembrolizumab 200 m5 on day 1 every 21 days for four cycles Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival is defined as the time from day 1 of treatment to death from any cause. Median overall survival was calculated for each arm.
Measured: Up to 60 months
Secondary outcomes (6)
Progression Free Survival (PFS)
PFS is defined as the time from first day of treatment until disease progression as defined by the response evaluation criteria in solid tumors (RECIST 1.1) and and Immune Related Response Criteria (irRC), or death from any cause death or progression.
RECIST 1.1 Progressive Disease (PD): >= 20% increase in the sum of the LD of the target lesions, Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, Nonprogressive disease (NPD): No measurable disease at the entrance of the study or otherwise non measurable disease will be assessed for progression.
irRC Progressive Disease (irPD), ≥20% increase in tumor burden and minimum 5 mm absolute increase in compared to nadir; for no new non-target or (irNN) and where irPR or irPD are confirmed by a repeat, consecutive assessment no less than 4 weeks later.
Measured: Up to 60 months
Overall Rates of Response (ORR)
ORR is defined as the number of subjects with complete response + partial response based on RECIST 1.1 and irRC criteria.
RECIST 1.1 Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >=30% decrease in the sum of the longest diameter (LD) of target lesions.
irRC Complete Response (irCR): Disappearance of all lesions, no new lesions, lymph nodes < 10 mm in short axis, Partial Response (irPR): ≥30% decrease in the sum of target lesions and non-target lesions are irNN.
Measured: 6 months
Rates of Response in Arm A and Arm B
Rates of Response is defined percent tumor size reduction based RECIST1.1 and irRC criteria (the latter if applicable) after each component of therapy in Arm A and Arm B.
Measured: 6 months
Toxicity Profile
The toxicity profile is classified and defined by both provider and the participants reported outcomes.
Clinician assessed toxicity will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) Participants assessed toxicity will be classified based on the Patient-Reported Outcome version of the CTCAE (PRO-CTCAE).
Adverse events occurring in greater than two patients or any grade 3 toxicity were included.
Measured: 6 months
Quality of Life (QOL) End of Treatment
Changes in QOL score for each subject are defined as the difference between the baseline, and at end of treatment.
QOL will be evaluated using The Functional Assessment of Cancer Therapy-Lung (FACT-Lung) scale at baseline and the end of treatment. The FACT-L is the FACT-G and a lung cancer-specific (LCS) subscale given at baseline and end of treatment. The FACT-G is a 27-item measure of general QOL assessing function in 4 domains: physical well-being, social-family well-being, emotional well-being, and functional well-being. Items are rated by patients on a Likert scale from 0 to 4. Higher scores represent better QOL.
Measured: Baseline to End of Treatment (up to 210 Days)
Quality of Life (QOL) 7 Weeks
Changes in QOL score for each subject are defined as the difference between the baseline, and at 7 weeks.
QOL will be evaluated using The Functional Assessment of Cancer Therapy-Lung (FACT-Lung) scale at baseline and 7 weeks. The FACT-L is the FACT-G and a lung cancer-specific (LCS) subscale given at baseline and at end of treatment. The FACT-G is a 27-item measure of general QOL assessing function in 4 domains: physical well-being, social-family well-being, emotional well-being, and functional well-being. Items are rated by patients on a Likert scale from 0 to 4. Higher scores represent better QOL.
Measured: Baseline to 7 weeks (40-50 Days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study start13 Sep 2016
- Primary completion19 Nov 2021
- Study completion19 Nov 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 Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Jared Weiss, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684461
- Sponsor's protocol ID
- LCCC 1516
- Status last verified
- May 2022
- First submitted
- 10 Feb 2016
- Last updated
- 3 Jun 2022
- 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 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Sequential Consolidation With Pembrolizumab Followed by Nab-paclitaxel After Standard First-Line Induction Chemotherapy in Advanced NSCLC
- ClinicalTrials.gov ID
- NCT02684461
- Acronym / sponsor ID
- LCCC 1516
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- lung cancer, PD-1 antibody, immune checkpoint blockade
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 13 Sep 2016 (actual)
- Primary completion
- 19 Nov 2021 (actual)
- Study completion
- 19 Nov 2021 (actual)
- First posted
- 18 Feb 2016 (estimated)
- Results
- Posted 3 Jun 2022
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 research study is to test the effectiveness of three treatment arms that are designed to improve survival in patients with non-small cell lung cancer. Eligible subjects could be randomized to four (4) cycles of chemotherapy followed by immunotherapy, or immunotherapy followed by chemotherapy, or four cycles of chemotherapy plus immunotherapy.
Detailed description
This open-label, three-arm, non-comparative randomized phase II study is designed to evaluate three different sequences of double-consolidation with the humanized monoclonal antibody targeted against cell surface receptor programmed cell death-1 (PD-1), pembrolizumab, and nab-paclitaxel in patients with advanced Non small cell lung cancer post induction chemotherapy. While the goal of each arm is to guarantee exposure to each of these two agents to patients who have not progressed post induction chemotherapy, they do so with different sequence. In ARMs A and B, consolidation is sequential, with either pembrolizumab followed by nab-paclitaxel (ARM A), or nab-paclitaxel followed by pembrolizumab (ARM B). In ARM C, consolidation is concurrent, with the two agents administered concurrently. As of July 24, ARMs B and C are closed, and no patients will be enrolled on this study. ARM A remains open to enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: Sequential Consolidation | Active comparator | Drug: PembrolizumabCompletion of four cycles of Sequential Consolidation of Pembrolizumab 200mg every 21 days and then four cycles Nab-paclitaxel 100 mg/mg2 on day 1 and day 8 every 21 days |
| Arm B: Sequential Consolidation | Active comparator | Drug: PembrolizumabCompletion of 4 cycles of Sequential Consolidation of Nab-paclitexel 100 mg/m2 on day 1 and day 8 every 21 days and then Pembrolizumab 200 mg every 21 |
| Arm C: Concurrent Consolidation | Active comparator | Drug: PembrolizumabConcurrent Consolidation of Nab paclitaxel 100 mg/m2 on day 1 and day 8 plus Pembrolizumab 200 m5 on day 1 every 21 days for four cycles |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Be willing and able to provide written informed consent for this trial
- Be greater than or equal to 18 years of age on day of signing consent
- Eastern Cooperative Oncology Group Performance Status less than or equal to 1
- Histologically or cytologically confirmed confirmed stage IV (metastatic) non small cell lung cancer as defined by American Joint Committee on Cancer (AJCC). Recurrent but not metastatic disease is allowed if deemed incurable.
- Has completed or scheduled to begin 4-6 cycles of platinum based induction chemotherapy that does not include a taxane
Key exclusion criteria (20 listed)
- Patients with epidermal growth factor receptor (EGFR) mutations expected to be sensitive to epidermal growth factor receptor (EGFR) inhibitors and patients with Echinoderm Microtubule-Associated Protein like 4 anaplastic lymphoma kinase (EML4/ALK) translocations are excluded, unless all available FDA approved targeted therapy options have been utilized. NOTE: In contrast to the above a patient with an EGFR mutation who has been treated with a first-generation and third generation TKIs and then with four cycles of carboplatin plus pemetrexed would be eligible
- Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose treatment
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1. Note: if subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
- Has had a prior monoclonal antibody within 4 weeks prior to study day 1 or who has not recovered from adverse events due to agents administered more than 4 weeks earlier. Exceptions to these criteria may be allowed at the discretion overall principal for toxicities that are not expected to be exacerbated by pembrolizumab or nab-paclitaxel
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, nab-paclitaxelReceive Pembrolizumab 200 mg on day 1 every 21 days for four cycles. Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles. | Drug | Arm A: Sequential Consolidation, Arm B: Sequential Consolidation, Arm C: Concurrent Consolidation |
Primary outcome
Overall Survival
Time frame: Up to 60 months
Overall survival is defined as the time from day 1 of treatment to death from any cause. Median overall survival was calculated for each arm.
6 secondary outcomes
Progression Free Survival (PFS)
Time frame: Up to 60 months
Overall Rates of Response (ORR)
Time frame: 6 months
Rates of Response in Arm A and Arm B
Time frame: 6 months
Toxicity Profile
Time frame: 6 months
Quality of Life (QOL) End of Treatment
Time frame: Baseline to End of Treatment (up to 210 Days)
Quality of Life (QOL) 7 Weeks
Time frame: Baseline to 7 weeks (40-50 Days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UNC Lineberger Comprehensive Cancer CenterLink 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.
Jared Weiss, MD principal investigator
University of North Carolina, Chapel Hill
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 UNC Lineberger Comprehensive Cancer Center 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 14 inclusion and 20 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 3 Jun 2022. 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 3 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?
Overall Survival (time frame: Up to 60 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 3 Jun 2022.