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Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671)

Primary Purpose

Non-small Cell Lung Cancer

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Pembrolizumab

Placebo

Cisplatin

Gemcitabine

Pemetrexed

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Have previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) NSCLC.
Be able to undergo protocol therapy, including necessary surgery. A positron emission tomography (PET) scan may be utilized as a surrogate for pathologic staging of N1 lymph nodes for participants with T2b and T4 tumors.
If male, must agree to use contraception or practice abstinence as well as refrain from donating sperm during the treatment period and for the time needed to eliminate each study intervention after the last dose of study intervention.
If female, may participate if not pregnant or breastfeeding, and at least one of the following conditions apply: 1) not a woman of childbearing potential (WOCBP); or 2) a WOCBP who agrees to follow contraceptive guidance during the treatment period and for the time needed to eliminate each study intervention after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period.
Have available formalin-fixed paraffin embedded (FFPE) tumor tissue sample blocks for submission. If blocks are not available, have unstained slides for submission for central programmed death-ligand 1 (PD-L1) testing.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days of randomization.
Have adequate organ function.

Exclusion Criteria:

Has one of the following tumor locations/types:1) NSCLC involving the superior sulcus; 2) Large cell neuro-endocrine cancer (LCNEC); or 3) Sarcomatoid tumor.
Has a history of (non-infectious) pneumonitis /interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease that requires steroids.
Has an active infection requiring systemic therapy.
Has had an allogenic tissue/sold organ transplant.
Has a known severe hypersensitivity (≥ Grade 3) to pembrolizumab, its active substance and/or any of its excipients.
Has a known severe hypersensitivity (≥ Grade 3) to any of the study chemotherapy agents and/or to any of their excipients.
Has an active autoimmune disease that has required systemic treatment in past 2 years.
Has a known history of human immunodeficiency virus (HIV) infection.
Has a known history of Hepatitis B or Hepatitis C.
Has a known history of active tuberculosis.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate.
Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor.
Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy prior to randomization/allocation.
Has received prior radiotherapy within 2 weeks of start of trial treatment.
Has received a live vaccine within 30 days prior to the first dose of trial drug.
Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of trial treatment.
Has a diagnosis of immunodeficiency or is receiving either systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of trial drug.
Has a known additional malignancy that is progressing or requires active treatment within the past 5 years.

Sites / Locations

Banner MD Anderson Cancer Center ( Site 0028)
Western Regional Medical Center, Inc. ( Site 0050)
University of Arizona Cancer Center - Dignity Health ( Site 0062)
University of Arizona Cancer Center ( Site 0012)
Pacific Cancer Medical Center, Inc. ( Site 0004)
Providence Saint Joseph Medical Center ( Site 0061)
Pacific Cancer Care ( Site 0035)
John Wayne Cancer Institute ( Site 0049)
St Joseph Heritage Healthcare ( Site 0040)
Stanford University, Stanford Cancer Center ( Site 0046)
Hartford Hospital ( Site 0069)
Helen F. Graham Cancer Center & Research Institute ( Site 0015)
Mayo Clinic Jacksonville ( Site 0022)
Miami Cancer Institute-Baptist Hospital ( Site 0068)
Southeastern Regional Medical Center ( Site 0051)
Northwest Oncology and Hematology ( Site 0001)
Ingalls Memorial Hospital ( Site 0044)
PPG-Oncology ( Site 0043)
University of Iowa Hospital and Clinics ( Site 0010)
Ashland-Bellefonte Cancer Center ( Site 0021)
Harry & Jeanette Weinberg Cancer Institute ( Site 0081)
Boston Medical Center ( Site 0057)
UMass Memorial Medical Center ( Site 0030)
Henry Ford Health System ( Site 0031)
Herbert Herman Cancer Center, Sparrow Hospital ( Site 0034)
Mayo Clinic ( Site 0026)
St. Vincent Healthcare Frontier Cancer Center ( Site 0005)
University of Nebraska Medical Center ( Site 0047)
Memorial Sloan Kettering Cancer Center Basking Ridge ( Site 0074)
Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0077)
MSKCC-Bergen ( Site 0075)
St. Peter's Hospital Cancer Care Center ( Site 0039)
Montefiore Einstein Center ( Site 0016)
Memorial Sloan-Kettering Cancer Center at Commack ( Site 0076)
Memorial Sloan Kettering Cancer Center Westchester ( Site 0079)
Memorial Sloan Kettering Cancer Center ( Site 0060)
Stony Brook University Medical Center - Cancer Center ( Site 0019)
Memorial Sloan Kettering Cancer Center - Nassau ( Site 0078)
White Plains Hospital Center for Cancer Care ( Site 0007)
Southwestern Regional Medical Center, Inc. ( Site 0054)
OHSU Center for Health & Healing ( Site 1006)
UPMC Pinnacle Health System - East Location ( Site 0063)
Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0053)
Allegheny General Hospital ( Site 0009)
UPMC Hillman Cancer Centers ( Site 0041)
VA Pittsburgh Healthcare System ( Site 0052)
Saint Francis Cancer Center ( Site 0096)
Emily Couric Clinical Cancer Center ( Site 0013)
Inova Schar Cancer Institute ( Site 0032)
Virginia Cancer Specialists, PC ( Site 0080)
Providence Regional Cancer Partnership ( Site 0065)
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0136)
Hospital Privado de Comunidad. ( Site 0130)
Hospital Universitario Austral ( Site 0127)
Fundacion Favaloro ( Site 0128)
Sanatorio Britanico ( Site 0125)
Sanatorio Parque ( Site 0135)
Hospital Provincial del Centenario ( Site 0131)
Hospital Privado Universitario de Córdoba ( Site 0139)
Sanatorio Allende ( Site 0129)
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica ( Site 0133)
Orange Health Services ( Site 0624)
Westmead Hospital ( Site 0621)
AZ Sint-Maarten ( Site 0226)
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0223)
UZ Gent ( Site 0224)
AZ Nikolaas ( Site 0225)
UZ Leuven ( Site 0221)
AZ Delta ( Site 0222)
Centro Regional Integrado de Oncologia ( Site 0160)
Instituto do Cancer do Ceara ( Site 0152)
Sirio-Libanes Brasilia - Centro de Oncologia - Asa Sul ( Site 0159)
Liga Norte Riograndense Contra o Cancer ( Site 0150)
Hospital de Caridade de Ijui ( Site 0153)
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0146)
Hospital Nossa Senhora da Conceicao ( Site 0145)
YNOVA Pesquisa Clinica ( Site 0823)
Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0144)
Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0149)
Hospital Paulistano - Amil Clinical Research ( Site 0822)
Hospital Alemao Oswaldo Cruz ( Site 0158)
Princess Margaret Cancer Centre ( Site 0109)
CIUSSS du Saguenay-Lac-St-Jean ( Site 0101)
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0110)
CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0104)
McGill University Health Centre ( Site 0111)
Tianjin Medical University General Hospital ( Site 0806)
Beijing Cancer Hospital ( Site 0810)
Beijing Cancer Hospital ( Site 0811)
Cancer Hospital Chinese Academy of Medical Sciences ( Site 0801)
Peking University Third Hospital ( Site 0812)
Peking Union Medical College Hospital ( Site 0809)
Sun Yat-Sen University Cancer Center ( Site 0816)
Hunan Cancer Hospital ( Site 0815)
Fudan University Shanghai Cancer Center ( Site 0813)
Zhongshan Hospital of Fudan University ( Site 0808)
Shanghai Pulmonary Hospital-Thoracic Surgery department ( Site 0817)
Tang Du Hospital ( Site 0803)
The First Affiliated Hospital of Zhejiang University ( Site 0804)
Zhejiang Cancer Hospital.... ( Site 0814)
Hwa Mei Hospital University of Chinese Academy of Sciences ( Site 0802)
SA Pohja-Eesti Regionaalhaigla ( Site 1100)
Hopital Foch ( Site 0243)
Nouvel Hopital Civil ( Site 0255)
CHU de Toulouse - Hopital Larrey ( Site 0258)
Clinique Francois Chenieux ( Site 0246)
Hospices Civils de Lyon Centre Hospitalier Lyon Sud ( Site 0241)
Centre Hospitalier Metropole Savoie Site de Chambery ( Site 0245)
Centre Hospitalier Annecy Genevois ( Site 0242)
CHU de Rouen ( Site 0252)
Hôpital Avicenne - Service d oncologie medicale ( Site 0249)
H.I.A. Sainte-Anne ( Site 0251)
Institut Curie ( Site 0250)
Klinikum Esslingen GmbH ( Site 0875)
LKI Lungenfachklinik Immenhausen ( Site 0268)
Florence Nightingale Krankenhaus ( Site 0874)
Lungenklinik Hemer ( Site 0269)
Mathias Spital Rheine ( Site 0261)
Katholisches Klinikum Koblenz Haus Marienhof ( Site 0873)
Universitaetsklinikum Carl Gustav Carus ( Site 0273)
Universitaetsklinikum Leipzig AOeR ( Site 0277)
LungenClinic Grosshansdorf GmbH ( Site 0267)
Universitaetsklinikum Schleswig Holstein ( Site 0871)
Zentralklinik Bad Berka GmbH ( Site 0264)
SRH Waldklinikum Gera GmbH ( Site 0272)
Evangelische Lungenklinik Berlin ( Site 0274)
HELIOS Klinikum Emil von Behring ( Site 0280)
Asklepios Klinikum Hamburg ( Site 0271)
Cork University Hospital ( Site 0452)
St James Hospital ( Site 0451)
Mid Western Cancer Centre ( Site 0450)
Istituto Nazionale Tumori ( Site 0309)
Azienda Ospedaliera dei Colli V. Monaldi ( Site 0301)
IRST-Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori ( Site 0300)
Istituto Clinico Humanitas Research Hospital ( Site 0314)
ASST Grande Ospedale Metropolitano Niguarda-Oncologia Falck ( Site 0315)
Azienda Ospedaliera San Gerardo ( Site 0308)
AOU San Luigi Gonzaga di Orbassano ( Site 0313)
Azienda Ospedaliera Spedali Civili di Brescia ( Site 0307)
IRCCS Ospedale San Raffaele di Milano ( Site 0303)
Azienda Ospedaliera San Camillo Forlanini ( Site 0311)
Aichi Cancer Center Hospital ( Site 0765)
National Cancer Center Hospital East ( Site 0761)
HP of the Univ. of Occupational and Environmental Health, Japan ( Site 0770)
Hyogo Cancer Center ( Site 0764)
St. Marianna University School of Medicine Hospital ( Site 0769)
Kanagawa Cancer Center ( Site 0763)
Oita University Hospital ( Site 0766)
Fukushima Medical University Hospital ( Site 0772)
Hiroshima University Hospital ( Site 0762)
National Cancer Center Hospital ( Site 0767)
Juntendo University Hospital ( Site 0768)
Tokyo Medical University Hospital ( Site 0771)
National Cancer Center ( Site 0702)
The Catholic University of Korea St. Vincent s Hospital ( Site 0705)
Asan Medical Center ( Site 0701)
Samsung Medical Center ( Site 0704)
SMG-SNU Boramae Medical Center ( Site 0707)
Pauls Stradins Clinical University Hospital ( Site 0911)
Riga East Clinical University Hospital ( Site 0912)
LSMUL Kauno Klinikos ( Site 0932)
Nacionalinis Vezio Institutas ( Site 0931)
Sarawak General Hospital ( Site 0782)
University Malaya Medical Centre ( Site 0781)
Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 0484)
Dolnoslaskie Centrum Onkologii. ( Site 0491)
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0488)
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi ( Site 0493)
Szpital Specjalistyczny w Prabutach Sp. z o.o. ( Site 0483)
Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0487)
S C Pelican Impex SRL ( Site 0506)
Centrul Medical Medicover Victoria ( Site 0514)
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0501)
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0515)
SC Radiotherapy Center Cluj SRL ( Site 0509)
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 0504)
S.C.R.T.C.Radiology Therapeutic Center SRL ( Site 0511)
S C Oncocenter Oncologie Medicala S R L ( Site 0505)
Spitalul Sf. Constantin ( Site 0512)
Euroclinic Hospital Bucharest ( Site 0510)
S.C.Focus Lab Plus S.R.L ( Site 0513)
Spitalul clinic Judetean de urgenta Constanta ( Site 0508)
Spitalul Judetean de Urgenta .Sf. Ioan cel Nou. ( Site 0503)
Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0530)
N.N. Blokhin NMRCO ( Site 0521)
National Medical Research Radiology Centre ( Site 0535)
Medical Rehabilitation Center ( Site 0534)
SBHI Leningrad Regional Clinical Hospital ( Site 0524)
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0533)
Municipal Clinical Oncology Center ( Site 0523)
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0529)
Tomsk Scientific Research Institute of Oncology ( Site 0526)
Wits Clinical Research ( Site 0570)
Wilgers Oncology Centre ( Site 0573)
The Oncology Centre ( Site 0571)
Cape Town Oncology Trials Pty Ltd ( Site 0572)
Hospital Germans Trias i Pujol. ICO de Badalona ( Site 0381)
Instituto Catalan de Oncologia - ICO ( Site 0388)
Hospital Universitario de Girona Doctor Josep Trueta ( Site 0386)
Hospital Universitario Insular de Gran Canaria ( Site 0383)
Hospital de la Santa Creu i Sant Pau ( Site 0385)
Hospital Universitari Vall d Hebron ( Site 0389)
Hospital General Universitario Gregorio Maranon ( Site 0382)
Hospital Virgen del Rocio ( Site 0387)
Kaohsiung Chang Gung Memorial Hospital ( Site 0725)
China Medical University Hospital ( Site 0724)
National Taiwan University Hospital ( Site 0721)
Taipei Veterans General Hospital ( Site 0722)
Tri-Service General Hospital ( Site 0726)
Chang Gung Medical Foundation.Linkou Branch ( Site 0723)
Cherkassy Regional Oncological Center ( Site 0613)
City Clinical Hosp.4 of DCC ( Site 0607)
MI Precarpathian Clinical Oncology Center ( Site 0603)
MI KhRC Kherson Regional Oncology Dispensary ( Site 0614)
PP PPC Acinus Medical and Diagnostic Centre ( Site 0609)
National Cancer Institute of the MoH of Ukraine ( Site 0605)
Kyiv City Clinical Oncological Center ( Site 0601)
MI Odessa Regional Oncological Centre ( Site 0608)
Zaporizhzhya Regional Clinical Oncology Center ( Site 0606)
Leicester Royal Infirmary ( Site 0447)
The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0456)
Royal Marsden NHS Foundation Trust ( Site 0458)
Royal Marsden Hospital ( Site 0457)
Nottingham City Hospital Campus ( Site 0441)
Heartlands Hospital in Birmingham ( Site 0455)
Freeman Hospital ( Site 0444)
Plymouth Hospitals NHS Trust ( Site 0443)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NAC + Neoadjuvant/Adjuvant Pembrolizumab

NAC + Neoadjuvant/Adjuvant Placebo

Arm Description

Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of pembrolizumab [200 mg, intravenous (IV); given on cycle day 1] in combination with platinum doublet neoadjuvant chemotherapy (NAC), consisting of cisplatin [75 mg/m^2, IV; given on cycle day 1] and either Gemcitabine [1000 mg/m^2, IV; given on cycle days 1 and 8] or Pemetrexed [500 mg/m^2, IV; given on cycle day 1]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of pembrolizumab [200 mg, IV; given on cycle day 1].

Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of placebo [normal saline, IV; given on cycle day 1] in combination with platinum doublet NAC, consisting of cisplatin [75 mg/m^2, IV; given on cycle day 1] and either Gemcitabine [1000 mg/m^2, IV; given on cycle days 1 and 8] or Pemetrexed [500 mg/m^2, IV; given on cycle day 1]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of placebo [normal saline, IV; given on cycle day 1].

Outcomes

Primary Outcome Measures

Event Free Survival (EFS)

EFS is defined as the time from randomization until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause. EFS determined either by biopsy assessed by local pathologist or by investigator-assessed imaging using RECIST 1.1.

Overall Survival (OS)

OS is defined as the time from randomization until death from any cause.

Secondary Outcome Measures

Major Pathological Response (mPR) Rate

mPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy.

Pathological Complete Response (pCR) Rate

pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.

Global Health Status/Quality of Life (GHS/QoL) Score using the European Organization for Research and Treatment (EORTC) QoL Questionnaire (QLQ-C30)

Change from baseline in GHS/QoL score using the EORTC QLQ-C30 will be determined. The EORTC QLQ-C30 is the most widely used cancer-specific, health-related QoL instrument comprised of 30 individual items arranged as both multi-item scales and individual items. Specifically, these items are divided into 5 functional scales (15 items total), 3 symptom scales (7 items total), 6 individual items, and a GHS/QoL scale composed of 2 items: GHS and QoL. The GHS/QoL score measured here refers to only the composite score calculated for the GHS/QoL scale. Both items on the GHS/QoL scale are scored from 1 (very poor GHS/QoL) to 7 (excellent GHS/QoL) and scores for both items are averaged and a linear transformation applied to standardize the overall GHS/QoL score from 0 to 100, with higher overall scores indicating higher GHS/QoL.

Adverse Events (AEs)

The number of participants experiencing an AE will be assessed. An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.

Perioperative Complications

The number of participants experiencing perioperative complications will be assessed. Perioperative complications are a discrete set of both intraoperative and postoperative complications, potentially contributing to increased length of inpatient care and/or delay of adjuvant therapy.

Treatment Discontinuations Due to AEs

The number of participants discontinuing study therapy due to an AE will be assessed.

Full Information

NCT ID

NCT03425643

First Posted

February 2, 2018

Last Updated

July 25, 2023

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT03425643

Brief Title

Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671)

Official Title

A Phase III, Randomized, Double-blind Trial of Platinum Doublet Chemotherapy +/-Pembrolizumab (MK-3475) as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (NSCLC) (KEYNOTE-671)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 24, 2018 (Actual)

Primary Completion Date

January 20, 2024 (Anticipated)

Study Completion Date

June 29, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery [neoadjuvant phase], followed by pembrolizumab alone after surgery [adjuvant phase] in participants with resectable stage II, IIIA, and resectable IIIB (T3-4N2) non-small cell lung cancer (NSCLC). The primary hypotheses of this study are that neoadjuvant pembrolizumab (vs. placebo) in combination with NAC, followed by surgery and adjuvant pembrolizumab (vs. placebo) will improve: 1) event free survival (EFS) by biopsy assessed by local pathologist or by investigator-assessed imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); and 2) overall survival (OS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

786 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NAC + Neoadjuvant/Adjuvant Pembrolizumab

Arm Type

Experimental

Arm Description

Arm Title

NAC + Neoadjuvant/Adjuvant Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

Pembrolizumab

Other Intervention Name(s)

KEYTRUDA®, MK-3475

Intervention Description

200 mg by IV infusion every 3 weeks (Q3W), given on cycle day 1.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Normal saline by IV infusion Q3W, given on cycle day 1.

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

PLATINOL®

Intervention Description

75 mg/m^2 by IV infusion Q3W, given on cycle day 1.

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

GEMZAR®

Intervention Description

1000 mg/m^2 by IV infusion Q3W, given on cycle days 1 and 8. Given only to participants with squamous NSCLC.

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Other Intervention Name(s)

Alimta®

Intervention Description

500 mg/m^2 by IV infusion Q3W, given on cycle day 1. Given only to participants with nonsquamous NSCLC.

Primary Outcome Measure Information:

Title

Event Free Survival (EFS)

Description

Time Frame

Up to approximately 5 years

Title

Overall Survival (OS)

Description

OS is defined as the time from randomization until death from any cause.

Time Frame

Up to approximately 5 years

Secondary Outcome Measure Information:

Title

Major Pathological Response (mPR) Rate

Description

mPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy.

Time Frame

Up to approximately 7 weeks following completion of neoadjuvant treatment (up to Study Week 20)

Title

Pathological Complete Response (pCR) Rate

Description

pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.

Time Frame

Up to approximately 7 weeks following completion of neoadjuvant treatment (up to Study Week 20)

Title

Global Health Status/Quality of Life (GHS/QoL) Score using the European Organization for Research and Treatment (EORTC) QoL Questionnaire (QLQ-C30)

Description

Time Frame

Baseline (cycle 1 in neoadjuvant phase) and end of follow-up (up to approximately 5 years)

Title

Adverse Events (AEs)

Description

Time Frame

Up to approximately 71 weeks

Title

Perioperative Complications

Description

Time Frame

Up to approximately 51 weeks following surgery

Title

Treatment Discontinuations Due to AEs

Description

The number of participants discontinuing study therapy due to an AE will be assessed.

Time Frame

Up to approximately 57 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) NSCLC. If male, must agree to use contraception or practice abstinence as well as refrain from donating sperm during the treatment period and for the time needed to eliminate each study intervention after the last dose of study intervention. If female, may participate if not pregnant or breastfeeding, and at least one of the following conditions apply: 1) not a woman of childbearing potential (WOCBP); or 2) a WOCBP who agrees to follow contraceptive guidance during the treatment period and for the time needed to eliminate each study intervention after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. Have available formalin-fixed paraffin embedded (FFPE) tumor tissue sample blocks for submission. If blocks are not available, have unstained slides for submission for central programmed death-ligand 1 (PD-L1) testing. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days of randomization. Have adequate organ function. Exclusion Criteria: Has one of the following tumor locations/types:1) NSCLC involving the superior sulcus; 2) Large cell neuro-endocrine cancer (LCNEC); or 3) Sarcomatoid tumor. Has a history of (non-infectious) pneumonitis /interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease that requires steroids. Has an active infection requiring systemic therapy. Has had an allogenic tissue/sold organ transplant. Has a known severe hypersensitivity (≥ Grade 3) to pembrolizumab, its active substance and/or any of its excipients. Has a known severe hypersensitivity (≥ Grade 3) to any of the study chemotherapy agents and/or to any of their excipients. Has an active autoimmune disease that has required systemic treatment in past 2 years. Has a known history of human immunodeficiency virus (HIV) infection. Has a known history of Hepatitis B or Hepatitis C. Has a known history of active tuberculosis. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate. Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor. Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy prior to randomization/allocation. Has received prior radiotherapy within 2 weeks of start of trial treatment. Has received a live vaccine within 30 days prior to the first dose of trial drug. Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of trial treatment. Has a diagnosis of immunodeficiency or is receiving either systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of trial drug. Has a known additional malignancy that is progressing or requires active treatment within the past 5 years.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

Facility Information:

Facility Name

Banner MD Anderson Cancer Center ( Site 0028)

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85234

Country

United States

Facility Name

Western Regional Medical Center, Inc. ( Site 0050)

City

Goodyear

State/Province

Arizona

ZIP/Postal Code

85338

Country

United States

Facility Name

University of Arizona Cancer Center - Dignity Health ( Site 0062)

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85004

Country

United States

Facility Name

University of Arizona Cancer Center ( Site 0012)

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724

Country

United States

Facility Name

Pacific Cancer Medical Center, Inc. ( Site 0004)

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Providence Saint Joseph Medical Center ( Site 0061)

City

Burbank

State/Province

California

ZIP/Postal Code

91505

Country

United States

Facility Name

Pacific Cancer Care ( Site 0035)

City

Monterey

State/Province

California

ZIP/Postal Code

93940

Country

United States

Facility Name

John Wayne Cancer Institute ( Site 0049)

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

St Joseph Heritage Healthcare ( Site 0040)

City

Santa Rosa

State/Province

California

ZIP/Postal Code

95403

Country

United States

Facility Name

Stanford University, Stanford Cancer Center ( Site 0046)

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Hartford Hospital ( Site 0069)

City

Hartford

State/Province

Connecticut

ZIP/Postal Code

06102

Country

United States

Facility Name

Helen F. Graham Cancer Center & Research Institute ( Site 0015)

City

Newark

State/Province

Delaware

ZIP/Postal Code

19718

Country

United States

Facility Name

Mayo Clinic Jacksonville ( Site 0022)

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Facility Name

Miami Cancer Institute-Baptist Hospital ( Site 0068)

City

Miami

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

Facility Name

Southeastern Regional Medical Center ( Site 0051)

City

Newnan

State/Province

Georgia

ZIP/Postal Code

30265

Country

United States

Facility Name

Northwest Oncology and Hematology ( Site 0001)

City

Elk Grove Village

State/Province

Illinois

ZIP/Postal Code

60007

Country

United States

Facility Name

Ingalls Memorial Hospital ( Site 0044)

City

Harvey

State/Province

Illinois

ZIP/Postal Code

60426

Country

United States

Facility Name

PPG-Oncology ( Site 0043)

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46845

Country

United States

Facility Name

University of Iowa Hospital and Clinics ( Site 0010)

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

Ashland-Bellefonte Cancer Center ( Site 0021)

City

Ashland

State/Province

Kentucky

ZIP/Postal Code

41101

Country

United States

Facility Name

Harry & Jeanette Weinberg Cancer Institute ( Site 0081)

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21237

Country

United States

Facility Name

Boston Medical Center ( Site 0057)

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

Facility Name

UMass Memorial Medical Center ( Site 0030)

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01655

Country

United States

Facility Name

Henry Ford Health System ( Site 0031)

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Herbert Herman Cancer Center, Sparrow Hospital ( Site 0034)

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48912

Country

United States

Facility Name

Mayo Clinic ( Site 0026)

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

St. Vincent Healthcare Frontier Cancer Center ( Site 0005)

City

Billings

State/Province

Montana

ZIP/Postal Code

59102

Country

United States

Facility Name

University of Nebraska Medical Center ( Site 0047)

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198-7680

Country

United States

Facility Name

Memorial Sloan Kettering Cancer Center Basking Ridge ( Site 0074)

City

Basking Ridge

State/Province

New Jersey

ZIP/Postal Code

07920

Country

United States

Facility Name

Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0077)

City

Middletown

State/Province

New Jersey

ZIP/Postal Code

07748

Country

United States

Facility Name

MSKCC-Bergen ( Site 0075)

City

Montvale

State/Province

New Jersey

ZIP/Postal Code

07645

Country

United States

Facility Name

St. Peter's Hospital Cancer Care Center ( Site 0039)

City

Albany

State/Province

New York

ZIP/Postal Code

12208

Country

United States

Facility Name

Montefiore Einstein Center ( Site 0016)

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

Facility Name

Memorial Sloan-Kettering Cancer Center at Commack ( Site 0076)

City

Commack

State/Province

New York

ZIP/Postal Code

11725

Country

United States

Facility Name

Memorial Sloan Kettering Cancer Center Westchester ( Site 0079)

City

Harrison

State/Province

New York

ZIP/Postal Code

10604

Country

United States

Facility Name

Memorial Sloan Kettering Cancer Center ( Site 0060)

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Stony Brook University Medical Center - Cancer Center ( Site 0019)

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11794-9447

Country

United States

Facility Name

Memorial Sloan Kettering Cancer Center - Nassau ( Site 0078)

City

Uniondale

State/Province

New York

ZIP/Postal Code

11553

Country

United States

Facility Name

White Plains Hospital Center for Cancer Care ( Site 0007)

City

White Plains

State/Province

New York

ZIP/Postal Code

10601

Country

United States

Facility Name

Southwestern Regional Medical Center, Inc. ( Site 0054)

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74133

Country

United States

Facility Name

OHSU Center for Health & Healing ( Site 1006)

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

UPMC Pinnacle Health System - East Location ( Site 0063)

City

Harrisburg

State/Province

Pennsylvania

ZIP/Postal Code

17109

Country

United States

Facility Name

Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0053)

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19124

Country

United States

Facility Name

Allegheny General Hospital ( Site 0009)

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15212

Country

United States

Facility Name

UPMC Hillman Cancer Centers ( Site 0041)

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

Facility Name

VA Pittsburgh Healthcare System ( Site 0052)

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15240

Country

United States

Facility Name

Saint Francis Cancer Center ( Site 0096)

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29607

Country

United States

Facility Name

Emily Couric Clinical Cancer Center ( Site 0013)

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22903

Country

United States

Facility Name

Inova Schar Cancer Institute ( Site 0032)

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22031

Country

United States

Facility Name

Virginia Cancer Specialists, PC ( Site 0080)

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22031

Country

United States

Facility Name

Providence Regional Cancer Partnership ( Site 0065)

City

Everett

State/Province

Washington

ZIP/Postal Code

98201

Country

United States

Facility Name

Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0136)

City

Berazategui

State/Province

Buenos Aires

ZIP/Postal Code

B1884BBF

Country

Argentina

Facility Name

Hospital Privado de Comunidad. ( Site 0130)

City

Mar del Plata

State/Province

Buenos Aires

ZIP/Postal Code

B7602CBM

Country

Argentina

Facility Name

Hospital Universitario Austral ( Site 0127)

City

Pilar

State/Province

Buenos Aires

ZIP/Postal Code

B1629ODT

Country

Argentina

Facility Name

Fundacion Favaloro ( Site 0128)

City

Ciudad de Buenos Aires

State/Province

Caba

ZIP/Postal Code

C1093AAS

Country

Argentina

Facility Name

Sanatorio Britanico ( Site 0125)

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000CVB

Country

Argentina

Facility Name

Sanatorio Parque ( Site 0135)

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000DSV

Country

Argentina

Facility Name

Hospital Provincial del Centenario ( Site 0131)

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2002KDS

Country

Argentina

Facility Name

Hospital Privado Universitario de Córdoba ( Site 0139)

City

Cordoba

ZIP/Postal Code

5016

Country

Argentina

Facility Name

Sanatorio Allende ( Site 0129)

City

Cordoba

ZIP/Postal Code

X5000JHQ

Country

Argentina

Facility Name

CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica ( Site 0133)

City

San Juan

ZIP/Postal Code

J5402DIL

Country

Argentina

Facility Name

Orange Health Services ( Site 0624)

City

Orange

State/Province

New South Wales

ZIP/Postal Code

2800

Country

Australia

Facility Name

Westmead Hospital ( Site 0621)

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

AZ Sint-Maarten ( Site 0226)

City

Mechelen

State/Province

Antwerpen

ZIP/Postal Code

2800

Country

Belgium

Facility Name

Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0223)

City

Liège

State/Province

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

UZ Gent ( Site 0224)

City

Gent

State/Province

Oost-Vlaanderen

ZIP/Postal Code

9000

Country

Belgium

Facility Name

AZ Nikolaas ( Site 0225)

City

Sint-Niklaas

State/Province

Oost-Vlaanderen

ZIP/Postal Code

9100

Country

Belgium

Facility Name

UZ Leuven ( Site 0221)

City

Leuven

State/Province

Vlaams-Brabant

ZIP/Postal Code

3000

Country

Belgium

Facility Name

AZ Delta ( Site 0222)

City

Roeselare

State/Province

West-Vlaanderen

ZIP/Postal Code

8800

Country

Belgium

Facility Name

Centro Regional Integrado de Oncologia ( Site 0160)

City

Fortaleza

State/Province

Ceara

ZIP/Postal Code

60336-232

Country

Brazil

Facility Name

Instituto do Cancer do Ceara ( Site 0152)

City

Fortaleza

State/Province

Ceara

ZIP/Postal Code

60430-230

Country

Brazil

Facility Name

Sirio-Libanes Brasilia - Centro de Oncologia - Asa Sul ( Site 0159)

City

Brasilia

State/Province

Distrito Federal

ZIP/Postal Code

70200-730

Country

Brazil

Facility Name

Liga Norte Riograndense Contra o Cancer ( Site 0150)

City

Natal

State/Province

Rio Grande Do Norte

ZIP/Postal Code

59075-740

Country

Brazil

Facility Name

Hospital de Caridade de Ijui ( Site 0153)

City

Ijui

State/Province

Rio Grande Do Sul

ZIP/Postal Code

98700 000

Country

Brazil

Facility Name

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0146)

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90610-000

Country

Brazil

Facility Name

Hospital Nossa Senhora da Conceicao ( Site 0145)

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

91350-200

Country

Brazil

Facility Name

YNOVA Pesquisa Clinica ( Site 0823)

City

Florianopolis

State/Province

Santa Catarina

ZIP/Postal Code

88020-210

Country

Brazil

Facility Name

Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0144)

City

Barretos

State/Province

Sao Paulo

ZIP/Postal Code

14784-400

Country

Brazil

Facility Name

Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0149)

City

Rio de Janeiro

ZIP/Postal Code

20230-130

Country

Brazil

Facility Name

Hospital Paulistano - Amil Clinical Research ( Site 0822)

City

Sao Paulo

ZIP/Postal Code

01321-001

Country

Brazil

Facility Name

Hospital Alemao Oswaldo Cruz ( Site 0158)

City

Sao Paulo

ZIP/Postal Code

01327-001

Country

Brazil

Facility Name

Princess Margaret Cancer Centre ( Site 0109)

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

CIUSSS du Saguenay-Lac-St-Jean ( Site 0101)

City

Chicoutimi

State/Province

Quebec

ZIP/Postal Code

G7H 5H6

Country

Canada

Facility Name

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0110)

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2X 0C1

Country

Canada

Facility Name

CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0104)

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1M5

Country

Canada

Facility Name

McGill University Health Centre ( Site 0111)

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4A 3J1

Country

Canada

Facility Name

Tianjin Medical University General Hospital ( Site 0806)

City

Tianjin

State/Province

Anhui

ZIP/Postal Code

300052

Country

China

Facility Name

Beijing Cancer Hospital ( Site 0810)

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100010

Country

China

Facility Name

Beijing Cancer Hospital ( Site 0811)

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100010

Country

China

Facility Name

Cancer Hospital Chinese Academy of Medical Sciences ( Site 0801)

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100021

Country

China

Facility Name

Peking University Third Hospital ( Site 0812)

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100191

Country

China

Facility Name

Peking Union Medical College Hospital ( Site 0809)

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100730

Country

China

Facility Name

Sun Yat-Sen University Cancer Center ( Site 0816)

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Facility Name

Hunan Cancer Hospital ( Site 0815)

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410013

Country

China

Facility Name

Fudan University Shanghai Cancer Center ( Site 0813)

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Name

Zhongshan Hospital of Fudan University ( Site 0808)

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Name

Shanghai Pulmonary Hospital-Thoracic Surgery department ( Site 0817)

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200433

Country

China

Facility Name

Tang Du Hospital ( Site 0803)

City

XI An

State/Province

Shanxi

ZIP/Postal Code

710038

Country

China

Facility Name

The First Affiliated Hospital of Zhejiang University ( Site 0804)

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310003

Country

China

Facility Name

Zhejiang Cancer Hospital.... ( Site 0814)

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310022

Country

China

Facility Name

Hwa Mei Hospital University of Chinese Academy of Sciences ( Site 0802)

City

Ningbo

State/Province

Zhejiang

ZIP/Postal Code

315010

Country

China

Facility Name

SA Pohja-Eesti Regionaalhaigla ( Site 1100)

City

Tallinn

State/Province

Harjumaa

ZIP/Postal Code

13419

Country

Estonia

Facility Name

Hopital Foch ( Site 0243)

City

Suresnes

State/Province

Ain

ZIP/Postal Code

92150

Country

France

Facility Name

Nouvel Hopital Civil ( Site 0255)

City

Strasbourg

State/Province

Bas-Rhin

ZIP/Postal Code

67091

Country

France

Facility Name

CHU de Toulouse - Hopital Larrey ( Site 0258)

City

Toulouse

State/Province

Haute-Garonne

ZIP/Postal Code

31100

Country

France

Facility Name

Clinique Francois Chenieux ( Site 0246)

City

Limoges

State/Province

Haute-Vienne

ZIP/Postal Code

87039

Country

France

Facility Name

Hospices Civils de Lyon Centre Hospitalier Lyon Sud ( Site 0241)

City

Pierre-Benite

State/Province

Rhone-Alpes

ZIP/Postal Code

69310

Country

France

Facility Name

Centre Hospitalier Metropole Savoie Site de Chambery ( Site 0245)

City

Chambery

State/Province

Savoie

ZIP/Postal Code

73011

Country

France

Facility Name

Centre Hospitalier Annecy Genevois ( Site 0242)

City

Pringy

State/Province

Savoie

ZIP/Postal Code

74374

Country

France

Facility Name

CHU de Rouen ( Site 0252)

City

Rouen

State/Province

Seine-Maritime

ZIP/Postal Code

76031

Country

France

Facility Name

Hôpital Avicenne - Service d oncologie medicale ( Site 0249)

City

Bobigny

State/Province

Seine-Saint-Denis

ZIP/Postal Code

93000

Country

France

Facility Name

H.I.A. Sainte-Anne ( Site 0251)

City

Toulon

State/Province

Var

ZIP/Postal Code

83800

Country

France

Facility Name

Institut Curie ( Site 0250)

City

Paris

ZIP/Postal Code

75248

Country

France

Facility Name

Klinikum Esslingen GmbH ( Site 0875)

City

Esslingen

State/Province

Baden-Wurttemberg

ZIP/Postal Code

73730

Country

Germany

Facility Name

LKI Lungenfachklinik Immenhausen ( Site 0268)

City

Immenhausen

State/Province

Hessen

ZIP/Postal Code

34376

Country

Germany

Facility Name

Florence Nightingale Krankenhaus ( Site 0874)

City

Duesseldorf

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

40489

Country

Germany

Facility Name

Lungenklinik Hemer ( Site 0269)

City

Hemer

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

58675

Country

Germany

Facility Name

Mathias Spital Rheine ( Site 0261)

City

Rheine

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

48431

Country

Germany

Facility Name

Katholisches Klinikum Koblenz Haus Marienhof ( Site 0873)

City

Koblenz

State/Province

Rheinland-Pfalz

ZIP/Postal Code

56073

Country

Germany

Facility Name

Universitaetsklinikum Carl Gustav Carus ( Site 0273)

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01307

Country

Germany

Facility Name

Universitaetsklinikum Leipzig AOeR ( Site 0277)

City

Leipzig

State/Province

Sachsen

ZIP/Postal Code

04103

Country

Germany

Facility Name

LungenClinic Grosshansdorf GmbH ( Site 0267)

City

Grosshansdorf

State/Province

Schleswig-Holstein

ZIP/Postal Code

22927

Country

Germany

Facility Name

Universitaetsklinikum Schleswig Holstein ( Site 0871)

City

Kiel

State/Province

Schleswig-Holstein

ZIP/Postal Code

24105

Country

Germany

Facility Name

Zentralklinik Bad Berka GmbH ( Site 0264)

City

Bad Berka

State/Province

Thuringen

ZIP/Postal Code

99437

Country

Germany

Facility Name

SRH Waldklinikum Gera GmbH ( Site 0272)

City

Gera

State/Province

Thuringen

ZIP/Postal Code

07548

Country

Germany

Facility Name

Evangelische Lungenklinik Berlin ( Site 0274)

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

HELIOS Klinikum Emil von Behring ( Site 0280)

City

Berlin

ZIP/Postal Code

14165

Country

Germany

Facility Name

Asklepios Klinikum Hamburg ( Site 0271)

City

Hamburg

ZIP/Postal Code

21075

Country

Germany

Facility Name

Cork University Hospital ( Site 0452)

City

Wilton

State/Province

Cork

Country

Ireland

Facility Name

St James Hospital ( Site 0451)

City

Dublin

ZIP/Postal Code

D08 K0Y5

Country

Ireland

Facility Name

Mid Western Cancer Centre ( Site 0450)

City

Limerick

ZIP/Postal Code

V98F858

Country

Ireland

Facility Name

Istituto Nazionale Tumori ( Site 0309)

City

Milano

State/Province

Abruzzo

ZIP/Postal Code

20133

Country

Italy

Facility Name

Azienda Ospedaliera dei Colli V. Monaldi ( Site 0301)

City

Napoli

State/Province

Campania

ZIP/Postal Code

80131

Country

Italy

Facility Name

IRST-Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori ( Site 0300)

City

Meldola

State/Province

Forli-Cesena

ZIP/Postal Code

47014

Country

Italy

Facility Name

Istituto Clinico Humanitas Research Hospital ( Site 0314)

City

Rozzano

State/Province

Lombardia

ZIP/Postal Code

20089

Country

Italy

Facility Name

ASST Grande Ospedale Metropolitano Niguarda-Oncologia Falck ( Site 0315)

City

Milan

State/Province

Milano

ZIP/Postal Code

20162

Country

Italy

Facility Name

Azienda Ospedaliera San Gerardo ( Site 0308)

City

Monza

State/Province

Monza E Brianza

ZIP/Postal Code

20900

Country

Italy

Facility Name

AOU San Luigi Gonzaga di Orbassano ( Site 0313)

City

Orbassano

State/Province

Torino

ZIP/Postal Code

10043

Country

Italy

Facility Name

Azienda Ospedaliera Spedali Civili di Brescia ( Site 0307)

City

Brescia

ZIP/Postal Code

25123

Country

Italy

Facility Name

IRCCS Ospedale San Raffaele di Milano ( Site 0303)

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Azienda Ospedaliera San Camillo Forlanini ( Site 0311)

City

Roma

ZIP/Postal Code

00152

Country

Italy

Facility Name

Aichi Cancer Center Hospital ( Site 0765)

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

464-8681

Country

Japan

Facility Name

National Cancer Center Hospital East ( Site 0761)

City

Kashiwa

State/Province

Chiba

ZIP/Postal Code

277-8577

Country

Japan

Facility Name

HP of the Univ. of Occupational and Environmental Health, Japan ( Site 0770)

City

Kitakyushu

State/Province

Fukuoka

ZIP/Postal Code

807-8556

Country

Japan

Facility Name

Hyogo Cancer Center ( Site 0764)

City

Akashi

State/Province

Hyogo

ZIP/Postal Code

673-8558

Country

Japan

Facility Name

St. Marianna University School of Medicine Hospital ( Site 0769)

City

Kawasaki

State/Province

Kanagawa

ZIP/Postal Code

216-8511

Country

Japan

Facility Name

Kanagawa Cancer Center ( Site 0763)

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

241-8515

Country

Japan

Facility Name

Oita University Hospital ( Site 0766)

City

Yufu

State/Province

Oita

ZIP/Postal Code

879-5593

Country

Japan

Facility Name

Fukushima Medical University Hospital ( Site 0772)

City

Fukushima

ZIP/Postal Code

960-1295

Country

Japan

Facility Name

Hiroshima University Hospital ( Site 0762)

City

Hiroshima

ZIP/Postal Code

734-8551

Country

Japan

Facility Name

National Cancer Center Hospital ( Site 0767)

City

Tokyo

ZIP/Postal Code

104-0045

Country

Japan

Facility Name

Juntendo University Hospital ( Site 0768)

City

Tokyo

ZIP/Postal Code

113-8431

Country

Japan

Facility Name

Tokyo Medical University Hospital ( Site 0771)

City

Tokyo

ZIP/Postal Code

160-0023

Country

Japan

Facility Name

National Cancer Center ( Site 0702)

City

Gyeonggi-do

State/Province

Kyonggi-do

ZIP/Postal Code

10408

Country

Korea, Republic of

Facility Name

The Catholic University of Korea St. Vincent s Hospital ( Site 0705)

City

Gyeonggi-do

State/Province

Kyonggi-do

ZIP/Postal Code

16247

Country

Korea, Republic of

Facility Name

Asan Medical Center ( Site 0701)

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Samsung Medical Center ( Site 0704)

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

SMG-SNU Boramae Medical Center ( Site 0707)

City

Seoul

ZIP/Postal Code

07071

Country

Korea, Republic of

Facility Name

Pauls Stradins Clinical University Hospital ( Site 0911)

City

Riga

ZIP/Postal Code

1002

Country

Latvia

Facility Name

Riga East Clinical University Hospital ( Site 0912)

City

Riga

ZIP/Postal Code

1079

Country

Latvia

Facility Name

LSMUL Kauno Klinikos ( Site 0932)

City

Kaunas

ZIP/Postal Code

50161

Country

Lithuania

Facility Name

Nacionalinis Vezio Institutas ( Site 0931)

City

Vilnius

ZIP/Postal Code

08406

Country

Lithuania

Facility Name

Sarawak General Hospital ( Site 0782)

City

Kuching

State/Province

Sarawak

ZIP/Postal Code

93586

Country

Malaysia

Facility Name

University Malaya Medical Centre ( Site 0781)

City

Kuala Lumpur

ZIP/Postal Code

59100

Country

Malaysia

Facility Name

Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 0484)

City

Bystra

State/Province

Dolnoslaskie

ZIP/Postal Code

43-360

Country

Poland

Facility Name

Dolnoslaskie Centrum Onkologii. ( Site 0491)

City

Wroclaw

State/Province

Dolnoslaskie

ZIP/Postal Code

53-413

Country

Poland

Facility Name

Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0488)

City

Bydgoszcz

State/Province

Kujawsko-pomorskie

ZIP/Postal Code

85-796

Country

Poland

Facility Name

Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi ( Site 0493)

City

Lodz

State/Province

Lodzkie

ZIP/Postal Code

93-513

Country

Poland

Facility Name

Szpital Specjalistyczny w Prabutach Sp. z o.o. ( Site 0483)

City

Prabuty

State/Province

Pomorskie

ZIP/Postal Code

82-550

Country

Poland

Facility Name

Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0487)

City

Poznan

State/Province

Wielkopolskie

ZIP/Postal Code

60-569

Country

Poland

Facility Name

S C Pelican Impex SRL ( Site 0506)

City

Oradea

State/Province

Bihor

ZIP/Postal Code

410450

Country

Romania

Facility Name

Centrul Medical Medicover Victoria ( Site 0514)

City

Bucharest

State/Province

Bucuresti

ZIP/Postal Code

010626

Country

Romania

Facility Name

Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0501)

City

Cluj Napoca

State/Province

Cluj

ZIP/Postal Code

400015

Country

Romania

Facility Name

Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0515)

City

Cluj-Napoca

State/Province

Cluj

ZIP/Postal Code

400015

Country

Romania

Facility Name

SC Radiotherapy Center Cluj SRL ( Site 0509)

City

Comuna Floresti

State/Province

Cluj

ZIP/Postal Code

407280

Country

Romania

Facility Name

S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 0504)

City

Craiova

State/Province

Dolj

ZIP/Postal Code

200347

Country

Romania

Facility Name

S.C.R.T.C.Radiology Therapeutic Center SRL ( Site 0511)

City

Otopeni

State/Province

Ilfov

ZIP/Postal Code

075100

Country

Romania

Facility Name

S C Oncocenter Oncologie Medicala S R L ( Site 0505)

City

Timisoara

State/Province

Timis

ZIP/Postal Code

300166

Country

Romania

Facility Name

Spitalul Sf. Constantin ( Site 0512)

City

Brasov

ZIP/Postal Code

500091

Country

Romania

Facility Name

Euroclinic Hospital Bucharest ( Site 0510)

City

Bucuresti

ZIP/Postal Code

014461

Country

Romania

Facility Name

S.C.Focus Lab Plus S.R.L ( Site 0513)

City

Bucuresti

ZIP/Postal Code

021389

Country

Romania

Facility Name

Spitalul clinic Judetean de urgenta Constanta ( Site 0508)

City

Constanta

ZIP/Postal Code

900591

Country

Romania

Facility Name

Spitalul Judetean de Urgenta .Sf. Ioan cel Nou. ( Site 0503)

City

Suceava

ZIP/Postal Code

720237

Country

Romania

Facility Name

Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0530)

City

Chelyabinsk

State/Province

Chelyabinskaya Oblast

ZIP/Postal Code

454087

Country

Russian Federation

Facility Name

N.N. Blokhin NMRCO ( Site 0521)

City

Moscow

State/Province

Moskva

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

National Medical Research Radiology Centre ( Site 0535)

City

Moscow

State/Province

Moskva

ZIP/Postal Code

125284

Country

Russian Federation

Facility Name

Medical Rehabilitation Center ( Site 0534)

City

Moscow

State/Province

Moskva

ZIP/Postal Code

125367

Country

Russian Federation

Facility Name

SBHI Leningrad Regional Clinical Hospital ( Site 0524)

City

Saint Petersburg

State/Province

Sankt-Peterburg

ZIP/Postal Code

194291

Country

Russian Federation

Facility Name

Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0533)

City

Saint Petersburg

State/Province

Sankt-Peterburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Municipal Clinical Oncology Center ( Site 0523)

City

Saint Petersburg

State/Province

Sankt-Peterburg

ZIP/Postal Code

198255

Country

Russian Federation

Facility Name

Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0529)

City

Kazan

State/Province

Tatarstan, Respublika

ZIP/Postal Code

420029

Country

Russian Federation

Facility Name

Tomsk Scientific Research Institute of Oncology ( Site 0526)

City

Tomsk

State/Province

Tomskaya Oblast

ZIP/Postal Code

634028

Country

Russian Federation

Facility Name

Wits Clinical Research ( Site 0570)

City

Parktown-Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2193

Country

South Africa

Facility Name

Wilgers Oncology Centre ( Site 0573)

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0081

Country

South Africa

Facility Name

The Oncology Centre ( Site 0571)

City

Durban

State/Province

Kwazulu-Natal

ZIP/Postal Code

4001

Country

South Africa

Facility Name

Cape Town Oncology Trials Pty Ltd ( Site 0572)

City

Kraaifontein

State/Province

Western Cape

ZIP/Postal Code

7570

Country

South Africa

Facility Name

Hospital Germans Trias i Pujol. ICO de Badalona ( Site 0381)

City

Badalona

State/Province

Barcelona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Instituto Catalan de Oncologia - ICO ( Site 0388)

City

L Hospitalet De Llobregat

State/Province

Barcelona

ZIP/Postal Code

08908

Country

Spain

Facility Name

Hospital Universitario de Girona Doctor Josep Trueta ( Site 0386)

City

Girona

State/Province

La Coruna

ZIP/Postal Code

17007

Country

Spain

Facility Name

Hospital Universitario Insular de Gran Canaria ( Site 0383)

City

Las Palmas de Gran Canaria

State/Province

Las Palmas

ZIP/Postal Code

35001

Country

Spain

Facility Name

Hospital de la Santa Creu i Sant Pau ( Site 0385)

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

Hospital Universitari Vall d Hebron ( Site 0389)

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Hospital General Universitario Gregorio Maranon ( Site 0382)

City

Madrid

ZIP/Postal Code

28009

Country

Spain

Facility Name

Hospital Virgen del Rocio ( Site 0387)

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Kaohsiung Chang Gung Memorial Hospital ( Site 0725)

City

Kaohsiung

ZIP/Postal Code

83301

Country

Taiwan

Facility Name

China Medical University Hospital ( Site 0724)

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

National Taiwan University Hospital ( Site 0721)

City

Taipei

ZIP/Postal Code

10048

Country

Taiwan

Facility Name

Taipei Veterans General Hospital ( Site 0722)

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

Tri-Service General Hospital ( Site 0726)

City

Taipei

ZIP/Postal Code

114

Country

Taiwan

Facility Name

Chang Gung Medical Foundation.Linkou Branch ( Site 0723)

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Cherkassy Regional Oncological Center ( Site 0613)

City

Cherkasy

State/Province

Cherkaska Oblast

ZIP/Postal Code

18009

Country

Ukraine

Facility Name

City Clinical Hosp.4 of DCC ( Site 0607)

City

Dnipro

State/Province

Dnipropetrovska Oblast

ZIP/Postal Code

49102

Country

Ukraine

Facility Name

MI Precarpathian Clinical Oncology Center ( Site 0603)

City

Ivano-Frankivsk

State/Province

Ivano-Frankivska Oblast

ZIP/Postal Code

76018

Country

Ukraine

Facility Name

MI KhRC Kherson Regional Oncology Dispensary ( Site 0614)

City

Kherson

State/Province

Khersonska Oblast

ZIP/Postal Code

73000

Country

Ukraine

Facility Name

PP PPC Acinus Medical and Diagnostic Centre ( Site 0609)

City

Kropyvnytsky

State/Province

Kirovohradska Oblast

ZIP/Postal Code

25006

Country

Ukraine

Facility Name

National Cancer Institute of the MoH of Ukraine ( Site 0605)

City

Kyiv

State/Province

Kyivska Oblast

ZIP/Postal Code

03022

Country

Ukraine

Facility Name

Kyiv City Clinical Oncological Center ( Site 0601)

City

Kyiv

State/Province

Kyivska Oblast

ZIP/Postal Code

03115

Country

Ukraine

Facility Name

MI Odessa Regional Oncological Centre ( Site 0608)

City

Odesa

State/Province

Odeska Oblast

ZIP/Postal Code

65055

Country

Ukraine

Facility Name

Zaporizhzhya Regional Clinical Oncology Center ( Site 0606)

City

Zaporizhzhya

State/Province

Zaporizka Oblast

ZIP/Postal Code

69040

Country

Ukraine

Facility Name

Leicester Royal Infirmary ( Site 0447)

City

Leicester

State/Province

Leicestershire

ZIP/Postal Code

LE1 5WW

Country

United Kingdom

Facility Name

The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0456)

City

Wirral

State/Province

Liverpool

ZIP/Postal Code

CH63 4JY

Country

United Kingdom

Facility Name

Royal Marsden NHS Foundation Trust ( Site 0458)

City

London

State/Province

London, City Of

ZIP/Postal Code

SW3 6JJ

Country

United Kingdom

Facility Name

Royal Marsden Hospital ( Site 0457)

City

Sutton

State/Province

London, City Of

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

Facility Name

Nottingham City Hospital Campus ( Site 0441)

City

Nottingham

State/Province

Nottinghamshire

ZIP/Postal Code

NG5 1PB

Country

United Kingdom

Facility Name

Heartlands Hospital in Birmingham ( Site 0455)

City

Birmingham

ZIP/Postal Code

B9 5SS

Country

United Kingdom

Facility Name

Freeman Hospital ( Site 0444)

City

Newcastle upon Tyne

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

Facility Name

Plymouth Hospitals NHS Trust ( Site 0443)

City

Plymouth

ZIP/Postal Code

PL6 8DH

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

IPD Sharing URL

http://engagezone.msd.com/ds_documentation.php

Citations:

PubMed Identifier

37272513

Citation

Wakelee H, Liberman M, Kato T, Tsuboi M, Lee SH, Gao S, Chen KN, Dooms C, Majem M, Eigendorff E, Martinengo GL, Bylicki O, Rodriguez-Abreu D, Chaft JE, Novello S, Yang J, Keller SM, Samkari A, Spicer JD; KEYNOTE-671 Investigators. Perioperative Pembrolizumab for Early-Stage Non-Small-Cell Lung Cancer. N Engl J Med. 2023 Aug 10;389(6):491-503. doi: 10.1056/NEJMoa2302983. Epub 2023 Jun 3.

Results Reference

result

PubMed Identifier

33661301

Citation

Romero Roman A, Campo-Canaveral de la Cruz JL, Macia I, Escobar Campuzano I, Figueroa Almanzar S, Delgado Roel M, Galvez Munoz C, Garcia Fontan EM, Muguruza Trueba I, Romero Vielva L, Cano Garcia JR, Martinez Tellez E, Partida Gonzalez C, Jimenez Lopez MF, Jimenez Maestre U, Mongil Poce R, Sanchez Lorente D, Alvarez Kindelan A, Provencio Pulla M. Outcomes of surgical resection after neoadjuvant chemoimmunotherapy in locally advanced stage IIIA non-small-cell lung cancer. Eur J Cardiothorac Surg. 2021 Jul 14;60(1):81-88. doi: 10.1093/ejcts/ezab007.

Results Reference

derived

Links:

URL

http://merckclinicaltrials.com/

Description

Merck Oncology Clinical Trials Information

Learn more about this trial

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