Small Cell Lung Cancer (SCLC)Phase 2NCT02934503
Study of Pembrolizumab and Chemotherapy With or Without Radiation in Small Cell Lung Cancer (SCLC)
A Phase 2 study testing Pembrolizumab, Cisplatin and Carboplatin in people with Small Cell Lung Cancer (SCLC), run by NYU Langone Health at 1 site in United States.
Trial summary
This trial is to assess the efficacy of pembrolizumab added to concurrent chemotherapy with or without radiation therapy in patients with small cell lung cancer (SCLC). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Small Cell Lung Cancer (SCLC)
- What is being tested?
- Pembrolizumab, Cisplatin and Carboplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2017to 1 Oct 2019
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have histologically confirmed small cell lung carcinoma not amenable to initial concurrent radiotherapy (extensive-stage disease).
- Participants may have evaluable or measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam.
- Participants in cohort B must have completed 1 cycle of systemic chemotherapy. Therapy with the combination must start no sooner than 3 weeks from the last dose of chemotherapy and no later than 5 weeks from the last dose of chemotherapy. Participants in cohort B must not have had progression of disease prior to the start of therapy.
- Participants in cohort C must have completed systemic therapy (4-6 cycles cisplatin or carboplatin + etoposides) and NOT be a candidate for consolidation thoracic radiotherapy or PCI. Participants in cohort C must initiate therapy with pembrolizumab within 6 weeks of the last dose of chemotherapy (therapy must not start within 2 weeks from the last dose). Participants in cohort C must not have had progression of disease prior to the start of therapy.
- Participants in cohort D must have completed systemic therapy AND have completed either consolidation thoracic radiotherapy or PCI or both completed either consolidation thoracic radiotherapy or PCI or both. Participants in cohort D must initiate therapy with pembrolizumab within 6 weeks of the last dose of radiation. Therapy must not start within 2 weeks from the last dose. Consolidation radiotherapy dose must NOT be more than 3000 centigray (cGy). Participants in cohort D must not have had progression of disease prior to the start of therapy.
- Age > 18 years.
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- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%)
- Life expectancy of greater than 3 months
- Participants must have normal organ and marrow function during screening and on Cycle 1, day 1 as defined below.
- Adequate Organ Function Laboratory Values
- System Laboratory Value Hematological
- Absolute neutrophil count (ANC) ≥1,500 /microliter (mcL)
- Platelets ≥100,000 / mcL
- Hemoglobin ≥9 g/dL or ≥5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment)
- Renal
- Serum creatinine OR Measured or ≤1.5 X upper limit of normal (ULN) OR calculated creatinine ≥60 mL/min for subject with creatinine clearance (GFR can also be used levels >1.5X institutional ULN in place of creatinine or CrCl)
- Hepatic
- Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN
- AST (SGOT) and Alanine transaminase (ALT) (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases
- Albumin >2.5 mg/dL
- Coagulation
- International Normalized Ratio ≤1.5 X ULN unless subject is receiving (INR) or Prothrombin Time (PT) anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
- Activated Partial Thromboplastin ≤1.5 X ULN unless subject is receiving Time (aPTT) anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.
- Availability of a diagnostic or pre-chemotherapy tissue biopsy is required (cytologic specimens or bone biopsies not accepted). This biopsy must be within 6 weeks of starting initial therapy. A minimum of 205 μm slides or block is required.
- Participants in cohorts B-D 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 within 4 weeks to initiation of treatment and AFTER the last dose of any prior therapy.
- Participants with treated brain metastases are allowed. Radiation must be completed at least 2 weeks prior to pembrolizumab dosing and participants must not require ongoing steroids. Participants with untreated brain metastases that are all <5 mm with no clinical symptoms or vasogenic edema may be allowed on study on a case-by-case basis on discussion with sponsor. These participants will require MRI monitoring every 6 weeks to ensure stability.
- The effects of pembrolizumab on the developing human fetus are unknown. For this reason and because the chemotherapy and radiation also used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) or be surgically sterile prior to study entry and for the duration of study participation. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of chemotherapy, radiation, and pembrolizumab administration.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Participants in cohort A may not have had prior therapy for their disease. Participants in cohort B may not have had more than 1 cycle of systemic therapy (cisplatin or carboplatin + etoposide). Participants in cohort C and D should not have had more than one prior regimen of chemotherapy.
- For participants entering cohorts C or D, prior treatment-related toxicities should have resolved to grade 1 or baseline (with the exception of anemia (as per inclusion criteria, alopecia, and neuropathy (< grade 2 allowed).
- Participants who have had a CR after pre-study therapy are not eligible for study.
- No thoracic radiation > 3000 cGy allowed.
- Prior radiation or surgery must have completed at least 2 weeks prior to initiation of therapy and all toxicities or complications from these must have resolved to baseline or grade 1 prior to starting therapy (with the exception of anemia (as per inclusion criteria, alopecia, and neuropathy (< grade 2 allowed).
- No stroke, myocardial infarction, or major surgery within 3 months of starting on therapy
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- Participants who are receiving any other investigational agents or have received investigational therapy or any anti-cancer monoclonal antibody (mAB) within 4 weeks prior to the 1st dose of pembrolizumab.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Has known history of non-infectious pneumonitis which required steroids, or any evidence of current, non-infectious pneumonitis.
- Has an active infection requiring systemic therapy.
- 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 a known history of active Bacillus Tuberculosis (TB)
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab, cisplatin, carboplatin, or etoposide.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- 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 known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C Virus (HCV) (e.g., HCV RNA [qualitative] is detected).
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- Has received a live vaccine within 30 days of planned start of study therapy Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist are live attenuated vaccines, and are not allowed.
- Has a known additional malignancy that is progressing or requires active treatment or has required active treatment within the last 2 years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer or in situ bladder cancer.
- Has a paraneoplastic syndrome other than SIADH (hyponatremia).
- Evidence of interstitial lung disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016
About this study
Official title: A Phase II Study of Pembrolizumab and Dynamic PD-L1 Expression in Extensive Stage Small Cell Lung Cancer (SCLC)
This trial is to assess the efficacy of pembrolizumab added to concurrent chemotherapy with or without radiation therapy in patients with small cell lung cancer (SCLC).
Read the detailed description
SCLC provides an opportune setting to evaluate the potential importance of variability in PD-L1 expression and its influence on optimizing timing and efficacy of checkpoint inhibition. All extensive stage SCLC patients are treated with chemotherapy and recent data suggests added benefit to consolidation thoracic radiation. A prior study of patients with known PD-L1 expression showed a 35% response rate. That study used archival specimens and found a 29% PD-L1 positivity rate (at 1% level) suggesting that the expression level and prevalence could be higher (and response rate/outcome therefore potentially better) in patients who have previously had chemotherapy or radiation. The proposed study seeks to evaluate pembrolizumab therapy initiated at different times during the course of SCLC treatment: a) up front, in conjunction with initiation of chemotherapy, b) starting after one cycle of chemotherapy, c) starting after completion of 1st line chemotherapy (4-6 cycles), d) starting after completion of consolidation thoracic radiation therapy and/or prophylactic cranial irradiation (PCI). Treatment with pembrolizumab will be preceded by biopsy for evaluation of PD-L1 expression with correlative evaluation of changes in PD-L1 expression (relative to diagnostic biopsy) and changes in other tissue- and blood-based biomarkers and immune markers.
- Conditions
- Small Cell Lung Cancer (SCLC)
- Being tested
- Pembrolizumab, Cisplatin, Carboplatin, Etoposide, Radiation therapy
- Keywords
- Chemotherapy, PD-L1, Thoracic radiotherapy, PD-1, MK-3475
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabBiological
Also called Keytruda
200 mg IV fixed dose every 3 weeks until progression or for up to 2 years of therapy.
CisplatinDrug
Also called Platinol
75 mg/m2
CarboplatinDrug
Also called Paraplatin
AUC 6
EtoposideDrug
Also called Etopophos
IV every 3 weeks for up to 6 cycles (minimum of 4 cycles, maximum of 6).
Radiation therapyRadiation
Thoracic radiotherapy will be given per institutional standards(dose and duration may vary for individual participants).
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin or carboplatin, Etoposide, Pembrolizumab & Radiation | Experimental | Cohort A: cisplatin (75 mg/m^2) + carboplatin (AUC 6) + etoposide (100mg/m^2) for four to six, 3-week cycles + pembrolizumab (200 mg) followed by radiation. Pembrolizumab will be started with first cycle of chemotherapy and continued for up to 2 years.
Cohort B: Pembrolizumab (200 mg) will be added to standard therapy with cisplatin (75 mg/m2) or carboplatin (AUC 6) and etoposide (100 mg/m2) (and radiation, if appropriate), after one 3- week cycle of standard therapy and continued for up to 2 years.
Cohort C: 200 mg IV infusion of Pembrolizumab every 3 weeks over about 30 minutes after completion of standard chemotherapy with cisplatin (75 mg/ m2) and etoposide (100 mg/m2). Treatment with pembrolizumab will continue for up to 2 years.
Cohort D: Pembrolizumab 200 mg IV infusion every 3 weeks in vein after completion of standard chemotherapy and radiation. Pembrolizumab will start within 6 weeks of completing radiation therapy and continue for up to 2 years. Receives: Biological: Pembrolizumab; Drug: Cisplatin; Drug: Carboplatin; Drug: Etoposide; Radiation: Radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PD-L1 Expression Status as Determined by Immunohistochemistry in Pretreatment and Archival Samples
Measured: up to 5 months
Secondary outcomes (4)
Number of Participants With Progression-free Survival (PFS)
Progression-Free Survival (PFS) is defined as the time from randomization (or registration) to the earlier of progression or death due to any cause
Measured: up to 6 months
Number of Participants With Overall Survival
Overall Survival (OS) is defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive.
Measured: up to 9 months
Response Evaluation Using Response Evaluation Criteria In Solid Tumors (RECIST)
Measured: at 6 weeks
Response Evaluation Using Response Evaluation Criteria In Solid Tumors (RECIST)
Measured: at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study start23 Jan 2017
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Why it stopped: This study was terminated as the standard of care for small cell lung cancer changed in 2018 to include immunotherapy in the front line setting, making this study no longer clinically relevant.
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 Small Cell Lung Cancer (SCLC)Studies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Joshua Sabari, MD,, Principal investigator, NYU Perlmutter Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934503
- Sponsor's protocol ID
- 16-01031
- Status last verified
- Oct 2021
- First submitted
- 13 Oct 2016
- Last updated
- 16 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Pembrolizumab and Dynamic PD-L1 Expression in Extensive Stage Small Cell Lung Cancer (SCLC)
- ClinicalTrials.gov ID
- NCT02934503
- Acronym / sponsor ID
- 16-01031
- Conditions
- Small Cell Lung Cancer (SCLC)
- Keywords
- Chemotherapy, PD-L1, Thoracic radiotherapy, PD-1, MK-3475
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated as the standard of care for small cell lung cancer changed in 2018 to include immunotherapy in the front line setting, making this study no longer clinically relevant.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 17 Oct 2016 (estimated)
- Results
- Posted 16 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is to assess the efficacy of pembrolizumab added to concurrent chemotherapy with or without radiation therapy in patients with small cell lung cancer (SCLC).
Detailed description
SCLC provides an opportune setting to evaluate the potential importance of variability in PD-L1 expression and its influence on optimizing timing and efficacy of checkpoint inhibition. All extensive stage SCLC patients are treated with chemotherapy and recent data suggests added benefit to consolidation thoracic radiation. A prior study of patients with known PD-L1 expression showed a 35% response rate. That study used archival specimens and found a 29% PD-L1 positivity rate (at 1% level) suggesting that the expression level and prevalence could be higher (and response rate/outcome therefore potentially better) in patients who have previously had chemotherapy or radiation. The proposed study seeks to evaluate pembrolizumab therapy initiated at different times during the course of SCLC treatment: a) up front, in conjunction with initiation of chemotherapy, b) starting after one cycle of chemotherapy, c) starting after completion of 1st line chemotherapy (4-6 cycles), d) starting after completion of consolidation thoracic radiation therapy and/or prophylactic cranial irradiation (PCI). Treatment with pembrolizumab will be preceded by biopsy for evaluation of PD-L1 expression with correlative evaluation of changes in PD-L1 expression (relative to diagnostic biopsy) and changes in other tissue- and blood-based biomarkers and immune markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cisplatin or carboplatin, Etoposide, Pembrolizumab & Radiation | Experimental | Biological: Pembrolizumab, Drug: Cisplatin, Drug: Carboplatin, Drug: Etoposide, Radiation: Radiation therapyCohort A: cisplatin (75 mg/m^2) + carboplatin (AUC 6) + etoposide (100mg/m^2) for four to six, 3-week cycles + pembrolizumab (200 mg) followed by radiation. Pembrolizumab will be started with first cycle of chemotherapy and continued for up to 2 years. Cohort B: Pembrolizumab (200 mg) will be added to standard therapy with cisplatin (75 mg/m2) or carboplatin (AUC 6) and etoposide (100 mg/m2) (and radiation, if appropriate), after one 3- week cycle of standard therapy and continued for up to 2 years. Cohort C: 200 mg IV infusion of Pembrolizumab every 3 weeks over about 30 minutes after completion of standard chemotherapy with cisplatin (75 mg/ m2) and etoposide (100 mg/m2). Treatment with pembrolizumab will continue for up to 2 years. Cohort D: Pembrolizumab 200 mg IV infusion every 3 weeks in vein after completion of standard chemotherapy and radiation. Pembrolizumab will start within 6 weeks of completing radiation therapy and continue for up to 2 years. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Participants must have histologically confirmed small cell lung carcinoma not amenable to initial concurrent radiotherapy (extensive-stage disease).
- Participants may have evaluable or measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam.
- Participants in cohort B must have completed 1 cycle of systemic chemotherapy. Therapy with the combination must start no sooner than 3 weeks from the last dose of chemotherapy and no later than 5 weeks from the last dose of chemotherapy. Participants in cohort B must not have had progression of disease prior to the start of therapy.
- Participants in cohort C must have completed systemic therapy (4-6 cycles cisplatin or carboplatin + etoposides) and NOT be a candidate for consolidation thoracic radiotherapy or PCI. Participants in cohort C must initiate therapy with pembrolizumab within 6 weeks of the last dose of chemotherapy (therapy must not start within 2 weeks from the last dose). Participants in cohort C must not have had progression of disease prior to the start of therapy.
- Participants in cohort D must have completed systemic therapy AND have completed either consolidation thoracic radiotherapy or PCI or both completed either consolidation thoracic radiotherapy or PCI or both. Participants in cohort D must initiate therapy with pembrolizumab within 6 weeks of the last dose of radiation. Therapy must not start within 2 weeks from the last dose. Consolidation radiotherapy dose must NOT be more than 3000 centigray (cGy). Participants in cohort D must not have had progression of disease prior to the start of therapy.
Key exclusion criteria (23 listed)
- Participants in cohort A may not have had prior therapy for their disease. Participants in cohort B may not have had more than 1 cycle of systemic therapy (cisplatin or carboplatin + etoposide). Participants in cohort C and D should not have had more than one prior regimen of chemotherapy.
- For participants entering cohorts C or D, prior treatment-related toxicities should have resolved to grade 1 or baseline (with the exception of anemia (as per inclusion criteria, alopecia, and neuropathy (< grade 2 allowed).
- Participants who have had a CR after pre-study therapy are not eligible for study.
- No thoracic radiation > 3000 cGy allowed.
- Prior radiation or surgery must have completed at least 2 weeks prior to initiation of therapy and all toxicities or complications from these must have resolved to baseline or grade 1 prior to starting therapy (with the exception of anemia (as per inclusion criteria, alopecia, and neuropathy (< grade 2 allowed).
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: Keytruda200 mg IV fixed dose every 3 weeks until progression or for up to 2 years of therapy. | Biological | Cisplatin or carboplatin, Etoposide, Pembrolizumab & Radiation |
| CisplatinAlso: Platinol75 mg/m2 | Drug | Cisplatin or carboplatin, Etoposide, Pembrolizumab & Radiation |
| CarboplatinAlso: ParaplatinAUC 6 | Drug | Cisplatin or carboplatin, Etoposide, Pembrolizumab & Radiation |
| EtoposideAlso: EtopophosIV every 3 weeks for up to 6 cycles (minimum of 4 cycles, maximum of 6). | Drug | Cisplatin or carboplatin, Etoposide, Pembrolizumab & Radiation |
| Radiation therapyThoracic radiotherapy will be given per institutional standards(dose and duration may vary for individual participants). | Radiation | Cisplatin or carboplatin, Etoposide, Pembrolizumab & Radiation |
Primary outcome
Change in PD-L1 Expression Status as Determined by Immunohistochemistry in Pretreatment and Archival Samples
Time frame: up to 5 months
4 secondary outcomes
Number of Participants With Progression-free Survival (PFS)
Time frame: up to 6 months
Number of Participants With Overall Survival
Time frame: up to 9 months
Response Evaluation Using Response Evaluation Criteria In Solid Tumors (RECIST)
Time frame: at 6 weeks
Response Evaluation Using Response Evaluation Criteria In Solid Tumors (RECIST)
Time frame: at 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- 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.
Joshua Sabari, MD, principal investigator
NYU Perlmutter Cancer Center
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 Pembrolizumab, Cisplatin and Carboplatin in people with Small Cell Lung Cancer (SCLC), run by NYU Langone Health 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 29 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Nov 2021. 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 16 Nov 2021). 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?
Change in PD-L1 Expression Status as Determined by Immunohistochemistry in Pretreatment and Archival Samples (time frame: up to 5 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 16 Nov 2021.