A Study of Pembrolizumab (MK-3475) in Combination With Chemotherapy or Immunotherapy in Participants With Non-small Cell Lung Cancer (MK-3475-021/KEYNOTE-021)
October 13, 2022 updated by: Merck Sharp & Dohme LLC
A Phase I/II Study of MK-3475 (SCH900475) in Combination With Chemotherapy or Immunotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma
The purpose of this study is to determine the safety, tolerability, and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy or immunotherapy in participants with unresectable or metastatic non-small cell lung cancer (NSCLC).
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
267
Phase
- Phase 2
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Stage IIIb/IV NSCLC
- Disease progression >1 year after completing adjuvant therapy for Stage I-IIIA disease and no systemic therapy for the recurrent disease
- Resolution of any toxic effects (excepting alopecia) of the most recent therapy
- At least one radiographically measurable lesion
- Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status scale
- Female participants of reproductive potential must not be pregnant (negative urine or serum human chorionic gonadotropin test within 72 hours of study start)
- Female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 120 days after the last dose of study therapy and for up to 180 days after the last dose of chemotherapeutic agents or tyrosine kinase inhibitors
Exclusion Criteria:
- Currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of administration of pembrolizumab
- Expected to require any other form of antineoplastic therapy while on study
- Is on chronic systemic steroid therapy or on any other form of immunosuppressive medication
- Has received a live-virus vaccination within 30 days of planned treatment start
- Clinically active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, or abdominal carcinomatosis (known risks factors for bowel perforation)
- History of a hematologic malignancy, primary brain tumor or sarcoma, or of another primary solid tumor, unless the participant has undergone potentially curative therapy with no evidence of that disease for 5 years
- Active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)
- Active autoimmune disease that has required systemic treatment in the past 2 years (replacement therapies for hormone deficiencies are allowed)
- Prior treatment with any other anti-programmed cell death protein-1 (anti-PD-1), or PD Ligand-1 (PD-L1) or PD Ligand-2 (PD-L2) agent or an antibody targeting other immuno-regulatory receptors or mechanisms
- Systemic cytotoxic chemotherapy, antineoplastic biologic therapy, or major surgery within 3 weeks of the first dose of study medication
- Radiation therapy to lung >30 Gy within 6 months of first dose of study medication
- Prior tyrosine kinase inhibitor therapy or palliative radiation within 7 days of first dose of study medication
- Active infection requiring therapy
- History of Human Immunodeficiency Virus (HIV)
- Active Hepatitis B or C
- Symptomatic ascites or pleural effusion
- Interstitial lung disease or pneumonitis requiring oral or IV glucocorticoids
- Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study
- Psychiatric disorders and substance (drug/alcohol) abuse
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Part 1 Cohort A2 (Pembro2mg/kg+Paclitaxel [Pa]+Carboplatin [C])
Cohort A participants receive pembrolizumab (2 mg/kg) via intravenous (IV) infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (Aare Under the Curve [AUC] 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
|
IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy
Other Names:
IV on Day 1 of each 3-week cycle for a maximum of 4 administrations
Other Names:
IV on Day 1 of each 3-week cycle for a maximum of 4 administrations
Other Names:
|
|
Experimental: Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])
Cohort B2 participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy
Other Names:
IV on Day 1 of each 3-week cycle for a maximum of 4 administrations
Other Names:
IV on Day 1 of each 3-week cycle for a maximum of 4 administrations
Other Names:
IV on Day 1 of each 3-week cycle
Other Names:
|
|
Experimental: Part 1 Cohort C2 (Pembro 2mg/kg+Pemetrexed [Pe]+C)
Cohort C2 participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
|
IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy
Other Names:
IV on Day 1 of each 3-week cycle for a maximum of 4 administrations
Other Names:
IV on Day 1 of each 3-week cycle
Other Names:
|
|
Experimental: Part 1 Cohort D1 (Pembro 10mg/kg+Ipilimumab [I])
Cohort D1 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy
Other Names:
IV on Day 1 of each 3-week cycle for a maximum of 4 administrations
Other Names:
|
|
Experimental: Part 1 Cohort E (Pembro 2mg/kg+Erlotinib)
Cohort E participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (150 mg) via oral tablet once a day on every day of each 3-week cycle.
|
IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy
Other Names:
Orally tablet once daily
Other Names:
|
|
Experimental: Part 1 Cohort F (Pembro 2mg/kg+Gefitinib)
Cohort F participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS gefitinib (250 mg) via oral tablet once a day on every day of each 3-week cycle.
|
IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy
Other Names:
Oral tablet once daily
Other Names:
|
|
Experimental: Part 2 Cohort G+ (Pembro 200mg+C+Pe)
Cohort G+ participants receive pembrolizumab (200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle.
|
IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy
Other Names:
IV on Day 1 of each 3-week cycle for a maximum of 4 administrations
Other Names:
IV on Day 1 of each 3-week cycle
Other Names:
|
|
Experimental: Part 2 Cohort H (Pembro+I)
Cohort H participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (1 mg/kg) via IV infusion on Day 1 of each 3-week cycle (at the recommended Phase II dose determined in Cohort D).
|
IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy
Other Names:
IV on Day 1 of each 3-week cycle for a maximum of 4 administrations
Other Names:
|
|
Experimental: Part 1 Cohort A10 (Pembro+Paclitaxel [Pa]+Carboplatin [C])
Cohort A10 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 6 [mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
|
IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy
Other Names:
IV on Day 1 of each 3-week cycle for a maximum of 4 administrations
Other Names:
IV on Day 1 of each 3-week cycle for a maximum of 4 administrations
Other Names:
|
|
Experimental: Part 1 Cohort B10 (Pembro+Pa+C+Bevacizumab [B])
Cohort B10 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy
Other Names:
IV on Day 1 of each 3-week cycle for a maximum of 4 administrations
Other Names:
IV on Day 1 of each 3-week cycle for a maximum of 4 administrations
Other Names:
IV on Day 1 of each 3-week cycle
Other Names:
|
|
Experimental: Part 1 Cohort C10 (Pembro 10mg/kg+Pemetrexed [Pe]+C)
Cohort C10 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
|
IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy
Other Names:
IV on Day 1 of each 3-week cycle for a maximum of 4 administrations
Other Names:
IV on Day 1 of each 3-week cycle
Other Names:
|
|
Experimental: Part 2 Cohort G- (Placebo+C+Pe)
Cohort G- participants receive placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS.
|
IV on Day 1 of each 3-week cycle for a maximum of 4 administrations
Other Names:
IV on Day 1 of each 3-week cycle
Other Names:
|
|
Experimental: Part 1 Cohort D2 (Pembro 10mg/kg+Ipilimumab [I])
Cohort D2 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (3 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy
Other Names:
IV on Day 1 of each 3-week cycle for a maximum of 4 administrations
Other Names:
|
|
Experimental: Part 1 Cohort D4 (Pembro 2mg/kg+Ipilimumab [I])
Cohort D1 participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
|
IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy
Other Names:
IV on Day 1 of each 3-week cycle for a maximum of 4 administrations
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Part 2 Cohorts G+ and G-: Objective Response Rate (ORR)
Time Frame: Up to approximately 2 years
|
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR).
|
Up to approximately 2 years
|
|
Part 2 Cohorts D4 and H: Objective Response Rate (ORR)
Time Frame: Up to approximately 2 years
|
For participants who demonstrated a confirmed response (Complete Response [CR]: Disappearance of all target lesions or Partial Response [PR]: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1.
Per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death.
DOR was assessed by BICR.
|
Up to approximately 2 years
|
|
All Cohorts: Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)
Time Frame: Cycle 1 (Up to 21 days)
|
DLTs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4. A DLT was defined as any of the following events: Grade 4 non-hematologic toxicity (not laboratory); Grade 4 hematologic toxicity lasting ≥7 days; Grade 3 non-hematologic toxicity (not laboratory, specifically nausea, vomiting and diarrhea) lasting >3 days despite optimal supportive care; Any Grade 3 or Grade 4 non-hematologic laboratory value requiring treatment or hospitalization, or persisting for >1 week; Febrile neutropenia Grade 3 or Grade 4; Qualifying thrombocytopenia <25,000/mm^3; Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Missing >10% of erlotinib or gefitinib doses as a result of adverse events (AEs) during the DLT window of observation; or Grade 5 toxicity.
|
Cycle 1 (Up to 21 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Part 2 Cohorts G+ and G-: Progression-Free Survival (PFS)
Time Frame: Up to approximately 2 years
|
PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first.
Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.
In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
The appearance of one or more new lesions was also considered progression.
PFS was assessed by BICR.
|
Up to approximately 2 years
|
|
Part 2 Cohorts G+ and G-: Overall Survival (OS)
Time Frame: Up to approximately 2 years
|
OS was defined as the time from randomization to death due to any cause.
|
Up to approximately 2 years
|
|
Part 2 Cohorts G+ and G-: Duration of Response (DOR)
Time Frame: Up to approximately 2 years
|
For participants who demonstrated a confirmed response (Complete Response [CR]: Disappearance of all target lesions or Partial Response [PR]: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1.
Per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death.
DOR was assessed by BICR.
|
Up to approximately 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Langer CJ, Gadgeel SM, Borghaei H, Papadimitrakopoulou VA, Patnaik A, Powell SF, Gentzler RD, Martins RG, Stevenson JP, Jalal SI, Panwalkar A, Yang JC, Gubens M, Sequist LV, Awad MM, Fiore J, Ge Y, Raftopoulos H, Gandhi L; KEYNOTE-021 investigators. Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study. Lancet Oncol. 2016 Nov;17(11):1497-1508. doi: 10.1016/S1470-2045(16)30498-3. Epub 2016 Oct 10.
- Borghaei H, Langer CJ, Gadgeel S, Papadimitrakopoulou VA, Patnaik A, Powell SF, Gentzler RD, Martins RG, Stevenson JP, Jalal SI, Panwalkar A, Yang JC, Gubens M, Sequist LV, Awad MM, Fiore J, Saraf S, Keller SM, Gandhi L. 24-Month Overall Survival from KEYNOTE-021 Cohort G: Pemetrexed and Carboplatin with or without Pembrolizumab as First-Line Therapy for Advanced Nonsquamous Non-Small Cell Lung Cancer. J Thorac Oncol. 2019 Jan;14(1):124-129. doi: 10.1016/j.jtho.2018.08.004. Epub 2018 Aug 21.
- Yang JC, Gadgeel SM, Sequist LV, Wu CL, Papadimitrakopoulou VA, Su WC, Fiore J, Saraf S, Raftopoulos H, Patnaik A. Pembrolizumab in Combination With Erlotinib or Gefitinib as First-Line Therapy for Advanced NSCLC With Sensitizing EGFR Mutation. J Thorac Oncol. 2019 Mar;14(3):553-559. doi: 10.1016/j.jtho.2018.11.028. Epub 2018 Dec 4.
- Gadgeel SM, Stevenson JP, Langer CJ, Gandhi L, Borghaei H, Patnaik A, Villaruz LC, Gubens M, Hauke R, Yang JC, Sequist LV, Bachman R, Saraf S, Raftopoulos H, Papadimitrakopoulou V. Pembrolizumab and platinum-based chemotherapy as first-line therapy for advanced non-small-cell lung cancer: Phase 1 cohorts from the KEYNOTE-021 study. Lung Cancer. 2018 Nov;125:273-281. doi: 10.1016/j.lungcan.2018.08.019. Epub 2018 Aug 25.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 21, 2014
Primary Completion (Actual)
November 7, 2016
Study Completion (Actual)
October 18, 2021
Study Registration Dates
First Submitted
January 16, 2014
First Submitted That Met QC Criteria
January 16, 2014
First Posted (Estimate)
January 17, 2014
Study Record Updates
Last Update Posted (Actual)
November 8, 2022
Last Update Submitted That Met QC Criteria
October 13, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Carcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Immune Checkpoint Inhibitors
- Folic Acid Antagonists
- Carboplatin
- Paclitaxel
- Erlotinib Hydrochloride
- Gefitinib
- Bevacizumab
- Pembrolizumab
- Pemetrexed
- Ipilimumab
Other Study ID Numbers
- 3475-021
- MK-3475-021 (Other Identifier: Merck Protocol Number)
- KEYNOTE-021 (Other Identifier: Merck)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pd
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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