- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03480230
Neoadjuvant Compound 121564 Plus Platinum Doublet Chemotherapy in Non-Small Cell Lung Cancer
Phase II Trial of Neoadjuvant Compound 121564 Plus Platinum Doublet Chemotherapy in Non-Small Cell Lung Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Arafat H Tfayli, MD
- Phone Number: 7986 +961 1 350 000
- Email: at35@aub.edu.lb
Study Locations
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-
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Amman, Jordan
- Not yet recruiting
- King Hussein Cancer Center
-
Contact:
- Taher Abu-Hejleh, MD
- Phone Number: +962 6 53 00 460
- Email: ta.11703@khcc.jo
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-
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Beirut, Lebanon
- Recruiting
- American University of Beirut Medical Center
-
Contact:
- Arafat H Tfayli, MD
- Phone Number: 7986 +961 1 350 000
- Email: at35@aub.edu.lb
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Beirut, Lebanon
- Recruiting
- Lebanese American University Medical Center-Rizk Hospital
-
Contact:
- Hady Ghanem, MD
- Phone Number: 5414 +961 76 477 647
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Beirut, Lebanon
- Not yet recruiting
- Bellevue Medical Center
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Contact:
- Fadi Karak, MD
- Phone Number: 5620 +961 1 682 666
- Email: elkarak@yahoo.com
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Sidon, Lebanon
- Not yet recruiting
- Hammoud Hospital University Medical Center
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Contact:
- Fadi Farhat, MD
- Phone Number: 1141 +961 7 723 111
- Email: drfadi.clinic@gmail.com; drfadi.research@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males and females aged ≥ 18 years.
- Histologically confirmed NSCLC (squamous and non-squamous).
- High-risk stage IB (tumor ≥ 4 cm in size, or grade 3, or with visceral pleura involvement), II or IIIA disease.
- Have biopsy tissue available (fresh and archived) for PD-L1 and correlative studies testing prior to therapy.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤
1. 6) Have a life expectancy of ≥ 6 months. 7) No previous systemic anticancer therapy or surgical resection for his or her NSCLC. 8) Subject has voluntarily agreed to participate by giving written informed consent for the trial. 9) Subject must be willing and able to comply with scheduled visits, treatment schedule and laboratory testing. 10) Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to receiving the first dose of study medication. 11) Females should not be breastfeeding. 12) Female subjects of childbearing potential as well as males sexually active with women of childbearing potential must be willing to use an adequate method of contraception. 13) Have pulmonary and cardiac function testing deemed adequate for thoracic surgical intervention. 14) Have adequate organ function by meeting the following:
- Absolute neutrophil count (ANC) ≥1,500/mcL.
- Platelets ≥100,000/mcL.
- Hemoglobin ≥9 g/dL.
- Serum creatinine ≤1.5 X upper limit of normal (ULN) OR calculated creatinine clearance (CrCl) (GFR can also be used in place of creatinine or CrCl) ≥60 mL/min for subjects with creatinine levels > 1.5 X institutional ULN.
- Serum total bilirubin ≤ ULN.
- AST (SGOT) and ALT (SGPT) ≤ 1.5 X ULN.
- Alkaline phosphatase ≤ 2.5 X ULN.
- International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless the subject is receiving anticoagulant therapy.
- Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless the subject is receiving anticoagulant therapy.
Exclusion Criteria:
- Subject deemed unfit for surgery (by pulmonary or cardiac assessment).
- Subject with known autoimmune disease that has required systemic therapy in the last 2 years.
- Prior organ transplantation including allogenic stem-cell transplantation.
- Clinically significant (i.e. active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
- Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 Grade > 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable.
- Subject on immunosuppressive therapy or corticosteroids within 14 days prior to starting study drugs.
- Subject with interstitial lung disease that is symptomatic or history of pneumonitis that required oral or systemic glucocorticoids to manage.
- Subject must have recovered from the effects of major surgery or significant trauma at least 14 days prior to therapy.
- Subject with previous malignancies are excluded unless complete remission was achieved at least 2 years prior to therapy.
- Other active malignancy requiring concurrent intervention.
- Subject with active infection requiring systemic therapy.
- Subject with known history of testing positive for human immunodeficiency virus (HIV) or known to have acquired immunodeficiency syndrome (AIDS).
- Subject has known active hepatitis B or C.
- Vaccination within 4 weeks of the first dose of Compound 121564 and while on trials is prohibited except for administration of inactivated vaccines.
- Subject is pregnant or breastfeeding.
- Subject has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Subject previously had a severe hypersensitivity reaction to any of the study drugs.
- Subject is currently participating and receiving study therapy from another clinical trial.
- Subject had prior treatment with any other anti-PD-1, or PD-L1 or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms.
- Patient who is not willing to sign the consent form.
- Legal incapacity or limited legal capacity patients receiving other oncology specific medication not authorized in the protocol.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment arm
|
Compound 121564 10 mg/Kg administered over 60 minutes given intravenously every 2 weeks for 4 doses plus chemotherapy depending on tumor histology.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate (ORR) as assessed by RECIST 1.1 criteria
Time Frame: At week 9
|
To assess the overall response rate (ORR) of patients receiving neoadjuvant Compound 121564 plus platinum doublet chemotherapy based on RECIST 1.1 criteria
|
At week 9
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pathologic complete response rate
Time Frame: At 12 weeks
|
To assess the pathologic complete response rate in patients receiving combination Compound 121564 and chemotherapy.
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At 12 weeks
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Major pathologic response rate (<10% viable tumor cells)
Time Frame: At 12 weeks
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To assess the major pathologic response rate (<10% viable tumor cells) in patients receiving combination Compound 121564 and chemotherapy.
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At 12 weeks
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Progression-Free Survival (PFS)
Time Frame: At 1, 2 and 3 years
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To assess progression-free survival (PFS) at 1, 2 and 3 years in patients receiving a combination of Compound 121564 plus platinum doublet chemotherapy.
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At 1, 2 and 3 years
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Overall Survival (OS)
Time Frame: At 1, 2 and 3 years
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To assess overall survival (OS) in patients receiving a combination of Compound 121564 plus platinum doublet chemotherapy.
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At 1, 2 and 3 years
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Overall Response Rate (ORR) as assessed by RECIST 1.1 criteria in enrolled squamous vs. non-squamous lung cancer patients
Time Frame: At week 9
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To compare the ORR in enrolled squamous vs. non-squamous lung cancer patients receiving the proposed treatment regimen.
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At week 9
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Progression-Free Survival (PFS) in enrolled squamous vs. non-squamous lung cancer patients
Time Frame: At 1, 2 and 3 years
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To compare the PFS in enrolled squamous vs. non-squamous lung cancer patients receiving the proposed treatment regimen.
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At 1, 2 and 3 years
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Overall Survival (OS) in enrolled squamous vs. non-squamous lung cancer patients
Time Frame: At 1, 2 and 3 years
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To compare the OS in enrolled squamous vs. non-squamous lung cancer patients receiving the proposed treatment regimen.
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At 1, 2 and 3 years
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Patient-related outcomes Quality of Life assessment using the questionnaire for functional assessment of cancer therapy for patients with lung cancer (FACT-L version 4)
Time Frame: At week 9
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To assess patient-related outcomes in patients receiving a combination of Compound 121564 plus platinum doublet chemotherapy.
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At week 9
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Number of participants with treatment-related adverse events as assessed by CTCAE v 4.0
Time Frame: With every administration
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To assess the tolerability of the proposed treatment regimen in the cohort of patient enrolled.
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With every administration
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Overall Response Rate (ORR) as assessed by RECIST 1.1 criteria in patients with 50% or more PD-L1 vs. patients with less than 50% PD-L1
Time Frame: At week 9
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To analyze as exploratory analysis the ORR in patients with 50% or more PD-L1 expression level vs. patients with less than 50% PD-L1 expression level receiving the proposed treatment regimen.
|
At week 9
|
Progression-Free Survival (PFS) in patients with 50% or more PD-L1 vs. patients with less than 50% PD-L1
Time Frame: At 1, 2 and 3 years
|
To analyze as exploratory analysis the PFS in patients with 50% or more PD-L1 expression level vs. patients with less than 50% PD-L1 expression level receiving the proposed treatment regimen.
|
At 1, 2 and 3 years
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Overall Survival (OS) in patients with 50% or more PD-L1 vs. patients with less than 50% PD-L1
Time Frame: At 1, 2 and 3 years
|
To analyze as exploratory analysis the OS in patients with 50% or more PD-L1 expression level vs. patients with less than 50% PD-L1 expression level receiving the proposed treatment regimen.
|
At 1, 2 and 3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arafat H Tfayli, MD, American University of Beirut Medical Center
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIO-2017-0467
- MS100070_0020 (OTHER_GRANT: Merck KGaA)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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