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| ID | Type | Description | Link |
|---|---|---|---|
| MS100070_0020 | Other Grant/Funding Number | Merck KGaA |
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| Name | Class |
|---|---|
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
| Phoenix Clinical Research | OTHER |
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The purpose of this study is to assess the response rate to neoadjuvant Compound 121564 plus platinum doublet chemotherapy in patients with early stage non-small cell lung cancer.
Open-label, single-arm multi-center phase II trial of neoadjuvant Compound 121564 plus platinum doublet chemotherapy conducted among patients with early stage (IB, II, IIIA) non-small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compound 121564 | Drug | Compound 121564 10 mg/Kg administered over 60 minutes given intravenously every 2 weeks for 4 doses plus chemotherapy depending on tumor histology. |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) as assessed by RECIST 1.1 criteria | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic complete response rate | To assess the pathologic complete response rate in patients receiving combination Compound 121564 and chemotherapy. | At 12 weeks |
| Major pathologic response rate (<10% viable tumor cells) |
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Inclusion Criteria:
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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arafat H Tfayli, MD | Contact | +961 1 350 000 | 7986 | at35@aub.edu.lb |
| Name | Affiliation | Role |
|---|---|---|
| Arafat H Tfayli, MD | American University of Beirut Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Hussein Cancer Center | Not yet recruiting | Amman | Jordan |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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To assess the major pathologic response rate (<10% viable tumor cells) in patients receiving combination Compound 121564 and chemotherapy.
| At 12 weeks |
| Progression-Free Survival (PFS) | To assess progression-free survival (PFS) at 1, 2 and 3 years in patients receiving a combination of Compound 121564 plus platinum doublet chemotherapy. | At 1, 2 and 3 years |
| Overall Survival (OS) | To assess overall survival (OS) in patients receiving a combination of Compound 121564 plus platinum doublet chemotherapy. | At 1, 2 and 3 years |
| Overall Response Rate (ORR) as assessed by RECIST 1.1 criteria in enrolled squamous vs. non-squamous lung cancer patients | To compare the ORR in enrolled squamous vs. non-squamous lung cancer patients receiving the proposed treatment regimen. | At week 9 |
| Progression-Free Survival (PFS) in enrolled squamous vs. non-squamous lung cancer patients | To compare the PFS in enrolled squamous vs. non-squamous lung cancer patients receiving the proposed treatment regimen. | At 1, 2 and 3 years |
| Overall Survival (OS) in enrolled squamous vs. non-squamous lung cancer patients | To compare the OS in enrolled squamous vs. non-squamous lung cancer patients receiving the proposed treatment regimen. | At 1, 2 and 3 years |
| 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) | To assess patient-related outcomes in patients receiving a combination of Compound 121564 plus platinum doublet chemotherapy. | At week 9 |
| Number of participants with treatment-related adverse events as assessed by CTCAE v 4.0 | To assess the tolerability of the proposed treatment regimen in the cohort of patient enrolled. | With every administration |
| 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 | 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 | 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 |
| Overall Survival (OS) in patients with 50% or more PD-L1 vs. patients with less than 50% PD-L1 | 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 |
| American University of Beirut Medical Center | Recruiting | Beirut | Lebanon |
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| Bellevue Medical Center | Not yet recruiting | Beirut | Lebanon |
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| Lebanese American University Medical Center-Rizk Hospital | Recruiting | Beirut | Lebanon |
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| Hammoud Hospital University Medical Center | Not yet recruiting | Sidon | Lebanon |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |