Nogapendekin Alfa Inbakicept for Advanced Non-Small Cell Lung Cancer

"This intervention combines Nogapendekin alfa inbakicept (NAI), an immunostimulatory protein complex, with pembrolizumab, an anti-PD-1 immune checkpoint inhibitor, for the treatment of NSCLC in Cohort A of QUILT-2.023.~Nogapendekin Alfa Inbakicept (NAI): A soluble complex consisting of two protein subunits of a human IL-15 variant bound with high affinity to a dimeric human IL-15Ra sushi domain/human IgG1 Fc fusion protein (inbakicept), serving as an immunostimulatory agent.~Dose: 15 µg/kg Route of Administration: Subcutaneously (SC)~Pembrolizumab: A humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby unleashing T-cell mediated immune responses against cancer cells.~Dose: 200 mg Route of Administration: Intravenously (IV)"

"Nogapendekin Alfa Inbakicept (NAI): A soluble complex consisting of two protein subunits of a human IL-15 variant bound with high affinity to a dimeric human IL-15Ra sushi domain/human IgG1 Fc fusion protein (inbakicept), serving as an immunostimulatory agent.~Dose: 15 µg/kg Route of Administration: Subcutaneously (SC)~Nivolumab: A PD-1 blocking antibody that enhances T-cell activity against cancer cells.~Dose: 3 mg/kg Route of Administration: Intravenously (IV) Schedule: Days 1, 15, and 29 every 6 weeks~Ipilimumab: A CTLA-4 blocking antibody that promotes T-cell activation and anti-tumor immunity.~Dose: 1 mg/kg Route of Administration: Intravenously (IV) Schedule: Day 1 every 6 weeks"

"Drug: Pembrolizumab~The reference treatment will consist of repeated 3-week cycles for a maximum treatment period of 2 years, in accordance with the following dosing regimen:~Day 1, every 3 weeks:~• Pembrolizumab (200 mg IV)"

"This intervention combines Nogapendekin alfa inbakicept (NAI), pembrolizumab (an anti-PD-1 immune checkpoint inhibitor), carboplatin (a platinum-based chemotherapy drug), and either nab-paclitaxel or paclitaxel (taxane chemotherapies) for the treatment of squamous NSCLC in Cohort B of the QUILT-2.023 trial.~Detailed Components:~Nogapendekin Alfa Inbakicept (NAI): An immunostimulatory protein complex.~Dose: 15 µg/kg Route of Administration: Subcutaneously (SC) Schedule: Day 1 every 3 weeks~Pembrolizumab: A PD-1 blocking antibody.~Dose: 200 mg Route of Administration: Intravenously (IV) Schedule: Day 1 every 3 weeks~Carboplatin: A platinum-based chemotherapy drug.~Dose: AUC 6 IV Route of Administration: Intravenously (IV) Schedule: Day 1 every 3 weeks for 4 cycles only (Induction phase)~Nab-paclitaxel or Paclitaxel: Taxane chemotherapy drugs. The investigator chooses which one to use"

"This intervention combines pembrolizumab, a PD-1 inhibitor, with carboplatin, and either nab-paclitaxel or paclitaxel (investigator's choice), for the treatment of squamous NSCLC in the control arm of the QUILT-2.023 trial for cohort B.~Detailed Components:~Pembrolizumab: A PD-1 blocking antibody.~Dose: 200 mg Route of Administration: Intravenously (IV) Schedule: Day 1, every 3 weeks Carboplatin: Chemotherapy agent.~Dose: AUC 6 IV Route of Administration: Intravenously (IV) Schedule: Day 1, every 3 weeks for 4 cycles only (Induction phase)~Nab-paclitaxel or Paclitaxel: Chemotherapy agents. The investigator chooses which one to use.~Nab-paclitaxel Dose: 100 mg/m²~Route of Administration: Intravenously (IV) Schedule: Day 1 and Days 8 and 15, every 3 weeks for 4 cycles (Induction phase)~Paclitaxel Dose: 200 mg/m²~Route of Administration: Intravenously (IV) Schedule: Day 1, every 3 weeks for 4 cycles (Induction phase)"

"Brief Description: Chemoimmunotherapy regimen to treat nonsquamous NSCLC in the experimental or control groups of Cohort C in the QUILT-2.023 study.~Detailed Components:~Cisplatin or Carboplatin:~Cisplatin Dosing: 75 mg/m2, intravenously Route: Intravenously (IV) Schedule: Day 1 every 3 weeks for 4 cycles (Induction Phase) OR~Carboplatin: Dosing at AUC 6 IV, intravenously Route: Intravenously (IV) Schedule: Day 1 every 3 weeks for 4 cycles (Induction Phase)~Pemetrexed:~Dosing at 500 mg/m2, intravenously Route: Intravenously (IV) Schedule: Day 1 every 3 weeks~Pembrolizumab:~Dosing at 200 mg Route: Intravenously (IV) Schedule: Day 1 every 3 weeks"

"This is a chemoimmunotherapy regimen to treat nonsquamous NSCLC in the experimental or control groups of Cohort C in the QUILT-2.023 study~Detailed Components:~Cisplatin or Carboplatin: Chemotherapy agents, the Investigator's choice between one or the other.~Cisplatin Dosing: 75 mg/m2, intravenously Route: Intravenously (IV) Schedule: Day 1 every 3 weeks for 4 cycles (Induction Phase) Carboplatin Dosing at AUC 6 IV Route: Intravenously (IV) Schedule: Day 1 every 3 weeks for 4 cycles (Induction Phase)~Pemetrexed:~Dosing at 500 mg/m2, intravenously Route: Intravenously (IV) Schedule: Day 1 every 3 weeks~Atezolizumab:~Dosing at 1200 mg Route: Intravenously (IV) Schedule: Day 1 every 3 weeks"

"This regimen combines chemotherapy agents with checkpoint and VEGF inhibitors to treat nonsquamous NSCLC in experimental and control groups of Cohort C in QUILT-2.023 trial.~Detailed Components:~Carboplatin:~Dosing at AUC 6 IV Route: Intravenously (IV) Schedule: Day 1 every 3 weeks for 4 cycles (Induction Phase)~Paclitaxel:~Dosing at 175 or 200 mg/m², intravenously (Investigator's Choice) Route: Intravenously (IV) Schedule: Day 1 every 3 weeks for 4 cycles (Induction Phase)~Atezolizumab:~Dosing at 1200 mg, intravenously Route: Intravenously (IV) Schedule: Day 1 every 3 weeks~Bevacizumab:~Dosing at 15mg/kg Route: Intravenously (IV) Schedule: Day 1 every 3 weeks"

"This regimen combines chemotherapy agents with a checkpoint inhibitor to treat nonsquamous NSCLC in experimental and control groups of Cohort C in QUILT-2.023 trial.~Detailed Components:~Carboplatin: Chemotherapy agent.~Dosing at AUC 6 IV~Route: Intravenously (IV)~Schedule: Day 1 every 3 weeks for 4 cycles (Induction Phase)~Nab-paclitaxel: Chemotherapy agent.~Dosing at 100 mg/m², intravenously~Route: Intravenously (IV)~Schedule: Days 1, 8, and 15 every 3 weeks for 4 cycles (Induction Phase)~Atezolizumab: Immunotherapy drug.~Dosing at 1200 mg~Route: Intravenously (IV)~Schedule: Day 1 every 3 weeks"

"This intervention combines Nogapendekin alfa inbakicept (NAI) with the checkpoint inhibitors nivolumab and ipilimumab, carboplatin (a chemotherapy agent), and nab-paclitaxel, and is being explored in NSCLC patients of Cohort D in the QUILT-2.023 trial.~Detailed Components:~Nogapendekin alfa inbakicept (NAI): Immunomodulatory agent. Dose: 1.2 mg Route of Administration: Subcutaneously (SC) Schedule: Days 1, 15, and 29 of each 6-week cycle~Nivolumab: Checkpoint inhibitor. Dose: 360 mg Route of Administration: Intravenously (IV) Schedule: Days 1 and 22 of each cycle~Ipilimumab: Checkpoint inhibitor. Dose: 1 mg/kg Route of Administration: Intravenously (IV) Schedule: Day 1 of each cycle~Carboplatin: Chemotherapy agent. Dose: AUC 6 Route of Administration: Intravenously (IV) Schedule: Days 1 and 22 (Cycle 1 only)~Nab-paclitaxel: Chemotherapy agent. Dose: 100 mg/m2 Route of Administration: Intravenously (IV) Schedule: Days 1, 8, 15, 22, 29, and 36 (Cycle 1 only)"