Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

1. Non-squamous histology:

   * Compound 121564 10 mg/Kg administered over 60 minutes given intravenously every 2 weeks for 4 doses.
   * Compound 565994 500 mg/m2 administered over 10 minutes, and
   * Compound 232673 AUC=5 mg/mL/min administered over 15-60 minutes or Compound 454893 at 75 mg/m2 over 1 hour.
   * Compound 565994 and platinum are to be given on day 1 of every 3-week cycle for 3 cycles.
2. Squamous histology:

   * Compound 121564 10 mg/Kg administered over 60 minutes every 2 weeks for 4 doses.
   * Compound 232673 AUC=5 mg/mL/min administered over 15-60 minutes or Compound 454893 at 75 mg/m2 over 1 hour on day 1 of every cycle.
   * Compound 343782 1,000 mg/m2 administered over 30 minutes on days 1 and 8 of each cycle.
   * Platinum and Compound 343782 will be given for 3 cycles.

Compound 121564 10 mg/Kg administered over 60 minutes given intravenously every 2 weeks for 4 doses plus chemotherapy depending on tumor histology.

Compound 121564

Arafat H Tfayli, MD

Taher Abu-Hejleh, MD

Fadi Karak, MD

Hady Ghanem, MD

Fadi Farhat, MD

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.

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

To assess the overall response rate (ORR) of patients receiving neoadjuvant Compound 121564 plus platinum doublet chemotherapy based on RECIST 1.1 criteria

To assess the pathologic complete response rate in patients receiving combination Compound 121564 and chemotherapy.

To assess the major pathologic response rate (\<10% viable tumor cells) in patients receiving combination Compound 121564 and chemotherapy.

To assess progression-free survival (PFS) at 1, 2 and 3 years in patients receiving a combination of Compound 121564 plus platinum doublet chemotherapy.

To assess overall survival (OS) in patients receiving a combination of Compound 121564 plus platinum doublet chemotherapy.

To compare the ORR in enrolled squamous vs. non-squamous lung cancer patients receiving the proposed treatment regimen.

To compare the PFS in enrolled squamous vs. non-squamous lung cancer patients receiving the proposed treatment regimen.

To compare the OS in enrolled squamous vs. non-squamous lung cancer patients receiving the proposed treatment regimen.

To assess patient-related outcomes in patients receiving a combination of Compound 121564 plus platinum doublet chemotherapy.

To assess the tolerability of the proposed treatment regimen in the cohort of patient enrolled.

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.

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.

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.

Spots Global Cancer Trial Database for compound 121564