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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03425643
Registration number
NCT03425643
Ethics application status
Date submitted
2/02/2018
Date registered
7/02/2018
Titles & IDs
Public 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)
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Scientific 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)
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Secondary ID [1]
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MK-3475-671
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Secondary ID [2]
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3475-671
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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0
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Pembrolizumab
Treatment: Drugs - Placebo
Treatment: Drugs - Cisplatin
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Pemetrexed
Experimental: NAC + Neoadjuvant/Adjuvant Pembrolizumab - 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 \[200 mg, IV; given on cycle day 1\].
Placebo comparator: NAC + Neoadjuvant/Adjuvant Placebo - 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 \[normal saline, IV; given on cycle day 1\].
Treatment: Other: Pembrolizumab
200 mg by IV infusion every 3 weeks (Q3W), given on cycle day 1.
Treatment: Drugs: Placebo
Normal saline by IV infusion Q3W, given on cycle day 1.
Treatment: Drugs: Cisplatin
75 mg/m\^2 by IV infusion Q3W, given on cycle day 1.
Treatment: Drugs: Gemcitabine
1000 mg/m\^2 by IV infusion Q3W, given on cycle days 1 and 8. Given only to participants with squamous NSCLC.
Treatment: Drugs: Pemetrexed
500 mg/m\^2 by IV infusion Q3W, given on cycle day 1. Given only to participants with nonsquamous NSCLC.
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Event Free Survival (EFS)
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Assessment method [1]
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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.
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Timepoint [1]
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Up to approximately 5 years
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Primary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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OS is defined as the time from randomization until death from any cause.
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Timepoint [2]
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Up to approximately 5 years
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Secondary outcome [1]
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Major Pathological Response (mPR) Rate
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Assessment method [1]
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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.
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Timepoint [1]
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Up to approximately 7 weeks following completion of neoadjuvant treatment (up to Study Week 20)
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Secondary outcome [2]
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Pathological Complete Response (pCR) Rate
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Assessment method [2]
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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.
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Timepoint [2]
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Up to approximately 7 weeks following completion of neoadjuvant treatment (up to Study Week 20)
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Secondary outcome [3]
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Global Health Status/Quality of Life (GHS/QoL) Score using the European Organization for Research and Treatment (EORTC) QoL Questionnaire (QLQ-C30)
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline (cycle 1 in neoadjuvant phase) and end of follow-up (up to approximately 5 years)
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Secondary outcome [4]
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Adverse Events (AEs)
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Assessment method [4]
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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.
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Timepoint [4]
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Up to approximately 71 weeks
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Secondary outcome [5]
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Perioperative Complications
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Assessment method [5]
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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.
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Timepoint [5]
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Up to approximately 51 weeks following surgery
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Secondary outcome [6]
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Treatment Discontinuations Due to AEs
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Assessment method [6]
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The number of participants discontinuing study therapy due to an AE will be assessed.
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Timepoint [6]
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Up to approximately 57 weeks
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/04/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
29/06/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
797
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Orange Health Services ( Site 0624) - Orange
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Recruitment hospital [2]
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Westmead Hospital ( Site 0621) - Westmead
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Recruitment postcode(s) [1]
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2800 - Orange
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment outside Australia
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Poland
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Dolnoslaskie
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Kujawsko-pomorskie
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Lodzkie
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Pomorskie
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Wielkopolskie
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Romania
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Bihor
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Romania
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Bucuresti
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Cluj
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Dolj
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Ilfov
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Timis
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Romania
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Brasov
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Romania
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Constanta
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Romania
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Suceava
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Russian Federation
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Chelyabinskaya Oblast
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Russian Federation
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Moskva
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Russian Federation
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Sankt-Peterburg
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Russian Federation
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Tatarstan, Respublika
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Russian Federation
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Tomskaya Oblast
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South Africa
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Gauteng
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Western Cape
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Spain
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Barcelona
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Spain
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La Coruna
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Spain
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Las Palmas
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Spain
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Madrid
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Spain
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Sevilla
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taipei
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Taoyuan
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Ukraine
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Cherkaska Oblast
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Ukraine
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Dnipropetrovska Oblast
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Ukraine
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Ivano-Frankivska Oblast
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Ukraine
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Khersonska Oblast
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Ukraine
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Kirovohradska Oblast
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Ukraine
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Kyivska Oblast
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Ukraine
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Odeska Oblast
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Ukraine
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Zaporizka Oblast
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United Kingdom
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Leicestershire
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United Kingdom
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Liverpool
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United Kingdom
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London, City Of
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United Kingdom
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Nottinghamshire
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United Kingdom
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Birmingham
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United Kingdom
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Newcastle upon Tyne
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United Kingdom
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Plymouth
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Merck Sharp & Dohme LLC
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Address
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT03425643
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Trial related presentations / publications
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. 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.
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Public notes
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Contacts
Principal investigator
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Medical Director
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Merck Sharp & Dohme LLC
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Wakelee H, Liberman M, Kato T, Tsuboi M, Lee SH, G...
[
More Details
]
Results not provided in
https://clinicaltrials.gov/study/NCT03425643