Non-Small Cell Lung CancerPhase 2KEYNOTE-782NCT03664024
Biomarkers of Response to Pembrolizumab Combined With Chemotherapy in Non-Small Cell Lung Cancer (KEYNOTE-782, MK-3475-782)
A Phase 2 study testing Pembrolizumab, Pemetrexed and Carboplatin in people with Non-Small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 15 sites in 5 countries.
Trial summary
Participants with Stage IV nonsquamous non-small cell lung cancer (NSCLC) without prior systemic treatment will be treated with standard of care pembrolizumab combined with platinum-doublet chemotherapy for 4 cycles, then pembrolizumab plus pemetrexed maintenance for up to 31 additional cycles. 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, Pemetrexed and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 15 sitesin 5 countries
- Study dates
- 30 Oct 2018to 5 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a histologically-confirmed or cytologically-confirmed diagnosis of stage IV (M1a, M1b, or M1c [AJCC 8th edition]) nonsquamous NSCLC.
- Have confirmation that epidermal growth factor receptor- (EGFR-), anaplastic lymphoma kinase- (ALK-), c-ros oncogene 1 (ROS1), or B isoform of rapidly accelerated fibrosarcoma (BRAF) directed therapy is not indicated as primary therapy. Documentation of the absence of tumor activating EGFR mutations, BRAF mutations, ALK gene rearrangements, and ROS1 gene rearrangements is required.
- Has measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- Has not received prior systemic treatment for their advanced/metastatic NSCLC. Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of metastatic disease.
- Have provided sufficient evaluable Stage IV, archival, solid tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion (that was not previously irradiated) for biomarker analysis (Fine Needle Aspiration [FNA] samples will not be accepted). Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 10 days prior to the first dose of study treatment.
Show all 10Show fewer
- A male participant must agree to use contraception through the end of treatment and for at least 120 days, and refrain from donating sperm during this period.
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and if participant is a woman of childbearing potential (WOCBP), agrees to follow the contraceptive guidance as provided in the protocol through the end of treatment.
- Has adequate organ function.
- Has provided blood for cell-free ctDNA analysis that has been received and determined to be of sufficient quality and quantity by the designated laboratory for the primary endpoint.
Who cannot join
- Has predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type.
- Has small cell elements present in NSCLC tumor.
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment allocation.
- Has clinically active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, peritoneal carcinomatosis.
- Has a known history of prior malignancy except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 2 years since initiation of that therapy.
- Has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
Show all 28Show fewer
- If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study intervention.
- Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system disease.
- Has received prior therapy with a multiple programmed cell death 1 (PD-1)/ (PD-1) receptor/programmed cell death ligand 1 (PD-L1) receptor inhibitor.
- Is expected to require any other form of antineoplastic therapy while on study (including maintenance therapy with another agent for NSCLC, radiation therapy, and/or surgical resection).
- Has received a live vaccine within 30 days prior to treatment.
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients or to another monoclonal antibody.
- Has a known sensitivity to any component of cisplatin, carboplatin or pemetrexed.
- Has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
- Is on chronic systemic steroids. Participants with asthma that require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study.
- Is unable or unwilling to take folic acid or vitamin B12 supplementation.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.
- Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority.
- Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV ribonucleic acid (RNA) [qualitative] is detected) infection.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
- Has a known psychiatric or substance abuse disorder that would interfere with cooperating with the requirements of the study.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study intervention.
- Has had an allogenic tissue/solid organ transplant.
Trial locations and contacts
15 sites in 5 countries.
15 sites in 5 countries
Spain5 sites
H.U. Vall de Hebron ( Site 0701)
Barcelona, 08035
Hospital Universitario Insular de Gran Canaria ( Site 0700)
Las Palmas de Gran Canaria, Gran Canaria, 35001
Hospital General Universitario 12 de Octubre ( Site 0703)
Madrid, 28041
Hospital Puerta de Hierro ( Site 0702)
Majadahonda, Madrid, 28222
Hospital Universitario Central de Asturias ( Site 0704)
Oviedo, 33011
United States3 sites
University Of Colorado ( Site 0908)
Aurora, Colorado, 80045
Harry & Jeanette Weinberg Cancer Institute ( Site 0901)
Baltimore, Maryland, 21237
Henry Ford Health System ( Site 0903)
Detroit, Michigan, 48202
Hungary3 sites
Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 0400)
Budapest, 1121
Petz Aladar Megyei Oktato Korhaz ( Site 0402)
Győr, 9024
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0401)
Szolnok, 5000
Canada2 sites
CISSS de la Monteregie-Centre ( Site 0801)
Greenfield Park, Quebec, J4V 2H1
Kingston General Hospital ( Site 0800)
Kingston, Ontario, K7L 2V7
Israel2 sites
Meir Medical Center ( Site 0501)
Kfar Saba, 4428164
Chaim Sheba Medical Center ( Site 0500)
Ramat Gan, 5262000
About this study
Official title: A Phase II Trial to Investigate Genetic Markers of Response to Pembrolizumab (MK-3475, SCH 900475) Combined With Chemotherapy as a First-line Treatment for Non-Small Cell Lung Cancer (KEYNOTE-782)
Participants with Stage IV nonsquamous non-small cell lung cancer (NSCLC) without prior systemic treatment will be treated with standard of care pembrolizumab combined with platinum-doublet chemotherapy for 4 cycles, then pembrolizumab plus pemetrexed maintenance for up to 31 additional cycles. The platinum doublet would be pemetrexed plus the investigator's choice of either cisplatin or carboplatin. The primary objective is to evaluate if total baseline tumor mutation burden (TMB) in cell-free circulating tumor deoxyribonucleic acid (ctDNA) is predictive of objective response per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by the investigator by estimating the level of association.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Pembrolizumab, Pemetrexed, Carboplatin, Cisplatin
- Keywords
- Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2), Carcinoma, Non-Small-Cell Lung, Adenocarcinoma
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Parkinson Disease 4, Autosomal Dominant Lewy Body, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Pembrolizumab, 200 mg, Day 1 of each 21-day cycle (Q3W), intravenous infusion (IV), standard of care in most countries
PemetrexedDrug
Pemetrexed, 500 mg/m^2 infusion, standard of care, Q3W, IV
CarboplatinDrug
Carboplatin AUC 5 mg/mL/min, IV infusion, Day 1 of each 21-day cycle for 4 cycles (Cycles 1 - 4). Investigator's choice of either cisplatin or carboplatin.
CisplatinDrug
Cisplatin, 75 mg/m^2, IV infusion, Day 1 of each 21-day cycle for 4 cycles (Cycles 1 - 4). Investigator's choice of either cisplatin or carboplatin.
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab Standard of Care | Experimental | Participants will receive standard of care pembrolizumab combined with platinum-doublet chemotherapy for 4 cycles, then pembrolizumab plus pemetrexed maintenance for up to 31 additional cycles. The platinum doublet would be pemetrexed plus the investigator's choice of either cisplatin or carboplatin. Receives: Drug: Pembrolizumab; Drug: Pemetrexed; Drug: Carboplatin; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Objective response rate is the proportion of participants who have a confirmed complete response (CR) or partial response (PR). Objective response rate is assessed by investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants with missing data are considered non-responders. The percentage of participants with an ORR is presented.
Measured: Up to ~25 months
Tumor Mutation Burden (TMB) in Cell-free Circulating Tumor Deoxyribonucleic Acid (ctDNA)
Cell-free ctDNA allows the exploration of tumor features from blood samples. TMB is a measure of mutational load in tumor cells and expressed as the number of somatic mutations per megabase (mut/MB) of DNA. The mean TMB in cell-free ctDNA of participants is presented.
Measured: Baseline (Day 1)
Secondary outcomes (4)
Progression Free Survival (PFS)
PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first as assessed by investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). The Kaplan-Meier estimate of median PFS using the product-limit (Kaplan-Meier) method for censored data is presented.
Measured: Up to ~36 months
Overall Survival (OS)
OS is defined as the time from the start of treatment to death due to any cause. The Kaplan-Meier estimate of median PFS using the product-limit (Kaplan-Meier) method for censored data is presented.
Measured: Up to ~36 months
Percentage of Participants Who Experienced One or More Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced an AE is presented.
Measured: Up to ~31 months
Percentage of Participants Discontinuing Study Intervention Due to an AE.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinued the study intervention due to an AE is presented.
Measured: Up to ~28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start30 Oct 2018
- Primary completion5 Nov 2021
- Study completion5 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664024
- Sponsor's protocol ID
- 3475-782
- Other IDs
- MK-3475-782, 2018-002598-22, 2018
- Acronym
- KEYNOTE-782
- Status last verified
- Jul 2024
- First submitted
- 7 Sep 2018
- Last updated
- 22 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
Bar J, Esteban E, Rodriguez-Abreu D, Aix SP, Szalai Z, Felip E, Gottfried M, Provencio M, Robinson A, Fulop A, Rao SB, Camidge DR, Speranza G, Townson SM, Kobie J, Ayers M, Dettman EJ, Hunkapiller N, McDaniel R, Jung B, Burkhardt D, Mauntz R, Csoszi T. Blood tumor mutational burden and response to pembrolizumab plus chemotherapy in non-small cell lung cancer: KEYNOTE-782. Lung Cancer. 2024 Apr;190:107506. doi: 10.1016/j.lungcan.2024.107506. Epub 2024 Feb 17.
PubMed 38422883
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial to Investigate Genetic Markers of Response to Pembrolizumab (MK-3475, SCH 900475) Combined With Chemotherapy as a First-line Treatment for Non-Small Cell Lung Cancer (KEYNOTE-782)
- ClinicalTrials.gov ID
- NCT03664024
- Acronym / sponsor ID
- KEYNOTE-782 / 3475-782
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2), Carcinoma, Non-Small-Cell Lung, Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 5 Nov 2021 (actual)
- Study completion
- 5 Nov 2021 (actual)
- First posted
- 10 Sep 2018 (actual)
- Results
- Posted 14 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants with Stage IV nonsquamous non-small cell lung cancer (NSCLC) without prior systemic treatment will be treated with standard of care pembrolizumab combined with platinum-doublet chemotherapy for 4 cycles, then pembrolizumab plus pemetrexed maintenance for up to 31 additional cycles. The platinum doublet would be pemetrexed plus the investigator's choice of either cisplatin or carboplatin. The primary objective is to evaluate if total baseline tumor mutation burden (TMB) in cell-free circulating tumor deoxyribonucleic acid (ctDNA) is predictive of objective response per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by the investigator by estimating the level of association.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab Standard of Care | Experimental | Drug: Pembrolizumab, Drug: Pemetrexed, Drug: Carboplatin, Drug: CisplatinParticipants will receive standard of care pembrolizumab combined with platinum-doublet chemotherapy for 4 cycles, then pembrolizumab plus pemetrexed maintenance for up to 31 additional cycles. The platinum doublet would be pemetrexed plus the investigator's choice of either cisplatin or carboplatin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Has a histologically-confirmed or cytologically-confirmed diagnosis of stage IV (M1a, M1b, or M1c [AJCC 8th edition]) nonsquamous NSCLC.
- Have confirmation that epidermal growth factor receptor- (EGFR-), anaplastic lymphoma kinase- (ALK-), c-ros oncogene 1 (ROS1), or B isoform of rapidly accelerated fibrosarcoma (BRAF) directed therapy is not indicated as primary therapy. Documentation of the absence of tumor activating EGFR mutations, BRAF mutations, ALK gene rearrangements, and ROS1 gene rearrangements is required.
- Has measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- Has not received prior systemic treatment for their advanced/metastatic NSCLC. Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of metastatic disease.
- Have provided sufficient evaluable Stage IV, archival, solid tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion (that was not previously irradiated) for biomarker analysis (Fine Needle Aspiration [FNA] samples will not be accepted). Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
Key exclusion criteria (28 listed)
- Has predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type.
- Has small cell elements present in NSCLC tumor.
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment allocation.
- Has clinically active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, peritoneal carcinomatosis.
- Has a known history of prior malignancy except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 2 years since initiation of that therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabPembrolizumab, 200 mg, Day 1 of each 21-day cycle (Q3W), intravenous infusion (IV), standard of care in most countries | Drug | Pembrolizumab Standard of Care |
| PemetrexedPemetrexed, 500 mg/m^2 infusion, standard of care, Q3W, IV | Drug | Pembrolizumab Standard of Care |
| CarboplatinCarboplatin AUC 5 mg/mL/min, IV infusion, Day 1 of each 21-day cycle for 4 cycles (Cycles 1 - 4). Investigator's choice of either cisplatin or carboplatin. | Drug | Pembrolizumab Standard of Care |
| CisplatinCisplatin, 75 mg/m^2, IV infusion, Day 1 of each 21-day cycle for 4 cycles (Cycles 1 - 4). Investigator's choice of either cisplatin or carboplatin. | Drug | Pembrolizumab Standard of Care |
Primary outcome
Objective Response Rate
Time frame: Up to ~25 months
Objective response rate is the proportion of participants who have a confirmed complete response (CR) or partial response (PR). Objective response rate is assessed by investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants with missing data are considered non-responders. The percentage of participants with an ORR is presented.
Tumor Mutation Burden (TMB) in Cell-free Circulating Tumor Deoxyribonucleic Acid (ctDNA)
Time frame: Baseline (Day 1)
Cell-free ctDNA allows the exploration of tumor features from blood samples. TMB is a measure of mutational load in tumor cells and expressed as the number of somatic mutations per megabase (mut/MB) of DNA. The mean TMB in cell-free ctDNA of participants is presented.
4 secondary outcomes
Progression Free Survival (PFS)
Time frame: Up to ~36 months
Overall Survival (OS)
Time frame: Up to ~36 months
Percentage of Participants Who Experienced One or More Adverse Events (AEs)
Time frame: Up to ~31 months
Percentage of Participants Discontinuing Study Intervention Due to an AE.
Time frame: Up to ~28 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38422883Bar J, Esteban E, Rodriguez-Abreu D, Aix SP, Szalai Z, Felip E, Gottfried M, Provencio M, Robinson A, Fulop A, Rao SB, Camidge DR, Speranza G, Townson SM, Kobie J, Ayers M, Dettman EJ, Hunkapiller N, McDaniel R, Jung B, Burkhardt D, Mauntz R, Csoszi T. Blood tumor mutational burden and response to pembrolizumab plus chemotherapy in non-small cell lung cancer: KEYNOTE-782. Lung Cancer. 2024 Apr;190:107506. doi: 10.1016/j.lungcan.2024.107506. Epub 2024 Feb 17.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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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.
Medical Director study director
Merck Sharp & Dohme LLC
15 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab, Pemetrexed and Carboplatin in people with Non-Small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 15 sites in 5 countries.
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 10 inclusion and 28 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 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain, United States, Hungary, Canada, Israel. 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 14 Nov 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?
Objective Response Rate (time frame: Up to ~25 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03664024, which also lists 1 linked publication.
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 22 Aug 2024.