Recurrent Non-Small Cell Lung CarcinomaPhase 2NCT02581943
Effect of Pembrolizumab With or Without Carboplatin and Paclitaxel on Immune Response in Patients With Recurrent or Stage IIIB-IV Non-small Cell Lung Cancer
A Phase 2 study testing Carboplatin, Laboratory Biomarker Analysis and Paclitaxel in people with Recurrent Non-Small Cell Lung Carcinoma and Stage IIIB Non-Small Cell Lung Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This randomized pilot phase II trial studies the effect of pembrolizumab with or without carboplatin and paclitaxel on immune response in patients with non-small cell lung cancer that has come back or stage IIIB-IV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Non-Small Cell Lung Carcinoma, Stage IIIB Non-Small Cell Lung Cancer, Stage IV Non-Small Cell Lung Cancer
- What is being tested?
- Carboplatin, Laboratory Biomarker Analysis and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2016to 28 Dec 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
- Patients must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) that is advanced/metastatic (stage IIIB/IV) or recurrent (progression after surgery or radiation or chemo-radiation treatment for loco-regional disease). Patients with epidermal growth factor (EGFR) mutation, anaplastic lymphoma kinase (ALK) gene rearrangement or ROS1 translocation must have received an approved EGFR, ALK, or ROS1-directed therapy and have signs of disease progression prior to receiving pembrolizumab.
- Patients must be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up to 12 weeks (84 days) prior to date of signing consent.
- Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen (up to 3 years) only upon agreement from the Sponsor. At least 4 mm of tumor tissue will be needed for PD-L1 staining.
- Patients who have received zero (0) to two (2) previous lines of systemic chemotherapy and are not currently receiving chemotherapy treatment (within 2 weeks of randomization).
- At least one measurable lesion as defined by RECIST v1.1 on screening computed tomography (CT) or magnetic resonance imaging (MRI)
- Age >18 years.
Show all 19Show fewer
- ECOG performance status of 2.
- Patients must have normal organ and marrow function as defined below:
- white blood cell count > 2,500 cells/mcL
- absolute neutrophil count >1,500/mcL
- platelets >100,000/mcL
- hemoglobin ≥ 9 g/dL
- total bilirubin ≤ 2.0 x upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT) < 2.5 x ULN Or ≤ 5 x ULN in presence of liver metastases
- creatinine within normal institutional limits OR
- creatinine clearance > 50 mL/min for patients with creatinine levels above institutional normal
- potassium ≥ lower limit of normal
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation and for 4 weeks after the final administration of study drugs. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign an IRB-approved informed consent document.
Who cannot join
- Known active (untreated) central nervous system (CNS) metastases that require steroids. Subjects with CNS metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for at least 2 weeks before study entry, defined as:
- No evidence of new or enlarging CNS metastasis or new neurological symptoms attributable to CNS metastases.
- Asymptomatic and receiving either no or stable doses of anticonvulsants and total doses of corticosteroids equivalent to 10 mg of prednisone or less.
- Current or previous other malignancy within 2 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy without sponsor approval.
- History of previous exposure to an anti PD1/PD-L1 agent
- Patients receiving any other investigational agents and or more than two different chemotherapy regimens for treatment of metastatic disease.
Show all 20Show fewer
- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
- Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
- Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab, paclitaxel or carboplatin.
- Current uncontrolled cardiac disease such as angina or myocardial infarction, congestive heart failure including New York Heart Association functional classification of 3, or arrhythmia requiring treatment.
- History of pneumonitis or active lung infection.
- Chronic or current active infectious disease requiring systemic antibiotics, antifungals, or antivirals.
- Patients receiving chronic steroids and or immunosuppression.
- Known HIV infection, Hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia or at risk for HBV reactivation. HBV DNA and testing for HCV RNA must be undetectable. At risk for HBV reactivation is defined as hepatitis B surface antigen positive or anti-hepatitis B core antibody positive.
- History of autoimmune disease(s).
- Psychiatric illness/social situations that would limit compliance with study requirements.
- Any other condition or circumstance that could interfere with adherence to the study's procedures or requirements, or otherwise compromise the study's objectives such as history of, or any evidence of active, non-infectious pneumonitis.
- Has an active infection requiring systemic therapy.
- Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants, breastfeeding should be discontinued prior to study entry.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Immune Response in Patients With Recurrent or Metastatic Non-small Cell Lung Cancer and Performance Status of 2 Treated With a Combination of Pembrolizumab and Low Dose Weekly Carboplatin/Paclitaxel
This randomized pilot phase II trial studies the effect of pembrolizumab with or without carboplatin and paclitaxel on immune response in patients with non-small cell lung cancer that has come back or stage IIIB-IV. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab together with carboplatin and paclitaxel may improve immune responses in patients with non-small cell lung cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the immune effects of single agent pembrolizumab and pembrolizumab combined with low-dose carboplatin and paclitaxel.
II. Estimate the treatment response to single agent pembrolizumab and pembrolizumab combined with low-dose carboplatin and paclitaxel.
SECONDARY OBJECTIVES:
- Determine the toxicity and tolerability of pembrolizumab and pembrolizumab combined with low-dose carboplatin and paclitaxel.
II. Assess quality of life (QOL) in patients receiving single agent pembrolizumab and pembrolizumab combined with carboplatin and paclitaxel.
III. Assess the association between immune response and clinical response.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1.
ARM II: Patients receive pembrolizumab IV over 30 minutes on day 1, paclitaxel IV over 1 hour and carboplatin IV over 1 hour on days 1, 7 and 14.
In both arms, courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for at least 30 days and then every 8 weeks thereafter.
- Conditions
- Recurrent Non-Small Cell Lung Carcinoma, Stage IIIB Non-Small Cell Lung Cancer, Stage IV Non-Small Cell Lung Cancer
- Being tested
- Carboplatin, Laboratory Biomarker Analysis, Paclitaxel, Pembrolizumab, Quality-of-Life Assessment
- 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.
CarboplatinDrug
Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies
PaclitaxelDrug
Also called Anzatax, Asotax, Bristaxol, Praxel
Given IV
PembrolizumabBiological
Also called Keytruda, Lambrolizumab, MK-3475, SCH 900475
Given IV
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (pembrolizumab) | Experimental | Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Receives: Other: Laboratory Biomarker Analysis; Biological: Pembrolizumab; Other: Quality-of-Life Assessment |
| Arm II (pembrolizumab, paclitaxel, carboplatin) | Experimental | Patients receive pembrolizumab IV over 30 minutes on day 1, paclitaxel IV over 1 hour and carboplatin IV over 1 hour on days 1, 7 and 14. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Receives: Drug: Carboplatin; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Biological: Pembrolizumab; Other: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Response
Duration of response will also be assessed in each group and compared using survival analysis methods. Per response evaluation criteria in Solid Tumors Criteria: Complete Response (irCR): Complete disappearance of all target and new, measurable lesions, with the exceptions of lymph nodes which must decrease to < 10 mm in short axis; Partial Response (irPR): Decrease in TMTB ≥ 30% relative to baseline; Stable Disease (irSD): Not meeting criteria for irCR or irPR, in absence of irPD; Progressive Disease (irPD): Increase in TMTB ≥ 20% relative to nadir.
Measured: Up to 2 years
Change in Effect of Treatment in Immune Markers From Baseline to End of Treatment (up to 2 Years)
Immune markers were measured at baseline and post-treatment. Data reported are the difference (post-pre) in these immune markers. Wilcoxon rank-sum tests were used to analyze the effects of the treatments on the change in immune markers.
Measured: Baseline and end of treatment (up to 2 years)
Objective Response Rate (ORR), Assessed Using RECIST
The Fisher's exact test methods will be used to estimate ORR between groups. The Exact Clopper-Pearson 95% confidence intervals will be calculated for each group. Per response evaluation criteria in Solid Tumors Criteria: Complete Response (irCR): Complete disappearance of all target and new, measurable lesions, with the exceptions of lymph nodes which must decrease to < 10 mm in short axis; Partial Response (irPR): Decrease in TMTB ≥ 30% relative to baseline; Stable Disease (irSD): Not meeting criteria for irCR or irPR, in absence of irPD; Progressive Disease (irPD): Increase in TMTB ≥ 20% relative to nadir.
Measured: Up to 2 years
Overall Survival
The Kaplan Meier curves will be used to estimate overall survival rates.
Measured: Duration of time from randomization to the time of death due to any cause, or the date the subject was last confirmed to be alive, assessed up to 3 years
Progression Free Survival
The Kaplan Meier curves will be used to estimate progression free survival rates. Per response evaluation criteria in Solid Tumors Criteria: Progressive Disease (irPD): Increase in TMTB ≥ 20% relative to nadir.
Measured: Duration of time from randomization to the time of immune-related progressive disease or death, whichever comes first, assessed up to 3 years
Secondary outcomes (2)
Number of Participants With Reported Adverse Events - CTCAE Version 4.0
Adverse events will be categorized by organ system and severity and summarized as frequency counts and percentages. A treatment will be considered too toxic if ≥6 of 20 patients in a cohort are removed from study because of toxicity.
Measured: At baseline, at week 8, week 12, week 20 and up to 30 days after last study drug is administered
Change in Immune Markers From Baseline to End of Treatment (up to 2 Years) With Treatment Response
Treatment response will be grouped into 3 categories as defined earlier in the protocol (complete or partial response, stable disease, progressive disease). The immune responses for patients within each of these 3 groups will be examined to determine whether there is evidence of an association. Immune markers were measured at baseline and post-treatment. Data reported are the difference (post-pre) in these immune markers. The change in markers (post-pre) are summarized and compared between treatment groups using a Kruskal Wallis test.
Measured: At baseline and post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study start17 Jun 2016
- Primary completion19 Nov 2022
- Study completion28 Dec 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 Recurrent Non-Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- William J Petty, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581943
- Sponsor's protocol ID
- IRB00034830
- Other IDs
- NCI-2015-01708, CCCWFU #62415, CCCWFU 62415, P30CA012197
- Status last verified
- Dec 2023
- First submitted
- 13 Oct 2015
- Last updated
- 5 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Response in Patients With Recurrent or Metastatic Non-small Cell Lung Cancer and Performance Status of 2 Treated With a Combination of Pembrolizumab and Low Dose Weekly Carboplatin/Paclitaxel
- ClinicalTrials.gov ID
- NCT02581943
- Acronym / sponsor ID
- IRB00034830
- Conditions
- Recurrent Non-Small Cell Lung Carcinoma, Stage IIIB Non-Small Cell Lung Cancer, Stage IV Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Jun 2016 (actual)
- Primary completion
- 19 Nov 2022 (actual)
- Study completion
- 28 Dec 2022 (actual)
- First posted
- 21 Oct 2015 (estimated)
- Results
- Posted 5 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized pilot phase II trial studies the effect of pembrolizumab with or without carboplatin and paclitaxel on immune response in patients with non-small cell lung cancer that has come back or stage IIIB-IV. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab together with carboplatin and paclitaxel may improve immune responses in patients with non-small cell lung cancer.
Detailed description
PRIMARY OBJECTIVES:
- Determine the immune effects of single agent pembrolizumab and pembrolizumab combined with low-dose carboplatin and paclitaxel.
II. Estimate the treatment response to single agent pembrolizumab and pembrolizumab combined with low-dose carboplatin and paclitaxel.
SECONDARY OBJECTIVES:
- Determine the toxicity and tolerability of pembrolizumab and pembrolizumab combined with low-dose carboplatin and paclitaxel.
II. Assess quality of life (QOL) in patients receiving single agent pembrolizumab and pembrolizumab combined with carboplatin and paclitaxel.
III. Assess the association between immune response and clinical response.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1.
ARM II: Patients receive pembrolizumab IV over 30 minutes on day 1, paclitaxel IV over 1 hour and carboplatin IV over 1 hour on days 1, 7 and 14.
In both arms, courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for at least 30 days and then every 8 weeks thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (pembrolizumab) | Experimental | Other: Laboratory Biomarker Analysis, Biological: Pembrolizumab, Other: Quality-of-Life AssessmentPatients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. |
| Arm II (pembrolizumab, paclitaxel, carboplatin) | Experimental | Drug: Carboplatin, Other: Laboratory Biomarker Analysis, Drug: Paclitaxel, Biological: Pembrolizumab, Other: Quality-of-Life AssessmentPatients receive pembrolizumab IV over 30 minutes on day 1, paclitaxel IV over 1 hour and carboplatin IV over 1 hour on days 1, 7 and 14. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) that is advanced/metastatic (stage IIIB/IV) or recurrent (progression after surgery or radiation or chemo-radiation treatment for loco-regional disease). Patients with epidermal growth factor (EGFR) mutation, anaplastic lymphoma kinase (ALK) gene rearrangement or ROS1 translocation must have received an approved EGFR, ALK, or ROS1-directed therapy and have signs of disease progression prior to receiving pembrolizumab.
- Patients must be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up to 12 weeks (84 days) prior to date of signing consent.
- Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen (up to 3 years) only upon agreement from the Sponsor. At least 4 mm of tumor tissue will be needed for PD-L1 staining.
- Patients who have received zero (0) to two (2) previous lines of systemic chemotherapy and are not currently receiving chemotherapy treatment (within 2 weeks of randomization).
- At least one measurable lesion as defined by RECIST v1.1 on screening computed tomography (CT) or magnetic resonance imaging (MRI)
Key exclusion criteria (20 listed)
- Known active (untreated) central nervous system (CNS) metastases that require steroids. Subjects with CNS metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for at least 2 weeks before study entry, defined as:
- Current or previous other malignancy within 2 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy without sponsor approval.
- History of previous exposure to an anti PD1/PD-L1 agent
- Patients receiving any other investigational agents and or more than two different chemotherapy regimens for treatment of metastatic disease.
- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
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 |
|---|---|---|
| CarboplatinAlso: Blastocarb, Carboplat, Carboplatin Hexal, CarboplatinoGiven IV | Drug | Arm II (pembrolizumab, paclitaxel, carboplatin) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (pembrolizumab), Arm II (pembrolizumab, paclitaxel, carboplatin) |
| PaclitaxelAlso: Anzatax, Asotax, Bristaxol, PraxelGiven IV | Drug | Arm II (pembrolizumab, paclitaxel, carboplatin) |
| PembrolizumabAlso: Keytruda, Lambrolizumab, MK-3475, SCH 900475Given IV | Biological | Arm I (pembrolizumab), Arm II (pembrolizumab, paclitaxel, carboplatin) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (pembrolizumab), Arm II (pembrolizumab, paclitaxel, carboplatin) |
Primary outcome
Duration of Response
Time frame: Up to 2 years
Duration of response will also be assessed in each group and compared using survival analysis methods. Per response evaluation criteria in Solid Tumors Criteria: Complete Response (irCR): Complete disappearance of all target and new, measurable lesions, with the exceptions of lymph nodes which must decrease to < 10 mm in short axis; Partial Response (irPR): Decrease in TMTB ≥ 30% relative to baseline; Stable Disease (irSD): Not meeting criteria for irCR or irPR, in absence of irPD; Progressive Disease (irPD): Increase in TMTB ≥ 20% relative to nadir.
Change in Effect of Treatment in Immune Markers From Baseline to End of Treatment (up to 2 Years)
Time frame: Baseline and end of treatment (up to 2 years)
Immune markers were measured at baseline and post-treatment. Data reported are the difference (post-pre) in these immune markers. Wilcoxon rank-sum tests were used to analyze the effects of the treatments on the change in immune markers.
Objective Response Rate (ORR), Assessed Using RECIST
Time frame: Up to 2 years
The Fisher's exact test methods will be used to estimate ORR between groups. The Exact Clopper-Pearson 95% confidence intervals will be calculated for each group. Per response evaluation criteria in Solid Tumors Criteria: Complete Response (irCR): Complete disappearance of all target and new, measurable lesions, with the exceptions of lymph nodes which must decrease to < 10 mm in short axis; Partial Response (irPR): Decrease in TMTB ≥ 30% relative to baseline; Stable Disease (irSD): Not meeting criteria for irCR or irPR, in absence of irPD; Progressive Disease (irPD): Increase in TMTB ≥ 20% relative to nadir.
Overall Survival
Time frame: Duration of time from randomization to the time of death due to any cause, or the date the subject was last confirmed to be alive, assessed up to 3 years
The Kaplan Meier curves will be used to estimate overall survival rates.
Progression Free Survival
Time frame: Duration of time from randomization to the time of immune-related progressive disease or death, whichever comes first, assessed up to 3 years
The Kaplan Meier curves will be used to estimate progression free survival rates. Per response evaluation criteria in Solid Tumors Criteria: Progressive Disease (irPD): Increase in TMTB ≥ 20% relative to nadir.
2 secondary outcomes
Number of Participants With Reported Adverse Events - CTCAE Version 4.0
Time frame: At baseline, at week 8, week 12, week 20 and up to 30 days after last study drug is administered
Change in Immune Markers From Baseline to End of Treatment (up to 2 Years) With Treatment Response
Time frame: At baseline and post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
William J Petty, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carboplatin, Laboratory Biomarker Analysis and Paclitaxel in people with Recurrent Non-Small Cell Lung Carcinoma and Stage IIIB Non-Small Cell Lung Cancer, run by Wake Forest University Health Sciences at 1 site 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 19 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 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 5 Jan 2024). 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?
Duration of Response (time frame: Up to 2 years). The study lists 5 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 5 Jan 2024.