Nogapendekin Alfa Inbakicept for Advanced Non-Small Cell Lung Cancer

Conditions

• Non Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• NAI + Pembrolizumab — DRUG
  Nogapendekin alfa inbakicept (NAI, also known as N-803, ANKTIVA): Dose: 15 µg/kg Route: Subcutaneous (SC) Schedule: Day 1 every 3 weeks Pembrolizumab: Dose: 200 mg Route: Intravenous (IV) Schedule: Day 1 every 3 weeks
• NAI + Nivolumab + Ipilimumab — DRUG
  Nogapendekin alfa inbakicept (NAI): Dose: 15 µg/kg Route: SC Schedule: Days 1 and 22 every 6 weeks Nivolumab: Dose: 3 mg/kg Route: IV Schedule: Days 1, 15, and 29 every 6 weeks Ipilimumab: Dose: 1 mg/kg Route: IV Schedule: Day 1 every 6 weeks
• NAI + Pembrolizumab + Carboplatin + Nab-paclitaxel or Paclitaxel — DRUG
  Induction (Cycles 1-4, q3w): Carboplatin: AUC 6 IV, Day 1 Nab-paclitaxel 100 mg/m² IV or Paclitaxel 200 mg/m² IV (Investigator's choice), Day 1 For nab-paclitaxel only: additional 100 mg/m² IV on Days 8 and 15 Pembrolizumab 200 mg IV, Day 1 Nogapendekin alfa inbakicept (NAI) 15 µg/kg SC, Day 1 Maintenance (Cycles ≥5, q3w): Pembrolizumab 200 mg IV, Day 1 Nogapendekin alfa inbakicept (NAI) 15 µg/kg SC, Day 1
• Cisplatin/Carboplatin + Pemetrexed + Pembrolizumab + NAI — DRUG
  Induction (Cycles 1-4, q3w): Cisplatin 75 mg/m² IV or Carboplatin AUC 6 IV, Day 1 Pemetrexed 500 mg/m² IV, Day 1 Pembrolizumab 200 mg IV, Day 1 Nogapendekin alfa inbakicept (NAI) 15 µg/kg SC, Day 1 Maintenance (Cycles ≥5, q3w): Pemetrexed 500 mg/m² IV, Day 1 Pembrolizumab 200 mg IV, Day 1 Nogapendekin alfa inbakicept (NAI) 15 µg/kg SC, Day 1
• Cisplatin/Carboplatin + Pemetrexed + Atezolizumab + NAI — DRUG
  Induction (Cycles 1-4, q3w): Atezolizumab 1200 mg IV, Day 1 Cisplatin 75 mg/m² IV or Carboplatin AUC 6 IV, Day 1 Pemetrexed 500 mg/m² IV, Day 1 Nogapendekin alfa inbakicept (NAI) 15 µg/kg SC, Day 1 Maintenance (Cycles ≥5, q3w): Atezolizumab 1200 mg IV, Day 1 Pemetrexed 500 mg/m² IV, Day 1 Nogapendekin alfa inbakicept (NAI) 15 µg/kg SC, Day 1
• Carboplatin + Paclitaxel + Atezolizumab + Bevacizumab + NAI — DRUG
  Induction (Cycles 1-4, q3w): Atezolizumab 1200 mg IV, Day 1 Bevacizumab 15 mg/kg IV, Day 1 Carboplatin AUC 6 IV, Day 1 Paclitaxel 175 or 200 mg/m² IV (Investigator's choice), Day 1 Nogapendekin alfa inbakicept (NAI) 15 µg/kg SC, Day 1 Maintenance (Cycles ≥5, q3w): Atezolizumab 1200 mg IV, Day 1 Bevacizumab 15 mg/kg IV, Day 1 Nogapendekin alfa inbakicept (NAI) 15 µg/kg SC, Day 1
• Carboplatin + Nab-paclitaxel + Atezolizumab + NAI — DRUG
  Induction (Cycles 1-4, q3w): Atezolizumab 1200 mg IV, Day 1 Carboplatin AUC 6 IV, Day 1 Nab-paclitaxel 100 mg/m² IV on Days 1, 8, and 15 Nogapendekin alfa inbakicept (NAI) 15 µg/kg SC, Day 1 Maintenance (Cycles ≥5, q3w): Atezolizumab 1200 mg IV, Day 1 Nogapendekin alfa inbakicept (NAI) 15 µg/kg SC, Day 1
• Pembrolizumab — DRUG
  Pembrolizumab 200 mg IV, Day 1 every 3 weeks
• Pembrolizumab + Carboplatin + Nab-paclitaxel or Paclitaxel — DRUG
  Induction (Cycles 1-4, q3w): Carboplatin AUC 6 IV, Day 1 Nab-paclitaxel 100 mg/m² IV or Paclitaxel 200 mg/m² IV, Day 1 For nab-paclitaxel only: additional 100 mg/m² IV on Days 8 and 15 Pembrolizumab 200 mg IV, Day 1 Maintenance (Cycles ≥5, q3w): Pembrolizumab 200 mg IV, Day 1
• Drug: Cisplatin/Carboplatin and Pemetrexed plus Pembrolizumab — DRUG
  Induction (Cycles 1-4, q3w): Cisplatin 75 mg/m² IV or Carboplatin AUC 6 IV, Day 1 Pemetrexed 500 mg/m² IV, Day 1 Pembrolizumab 200 mg IV, Day 1 Maintenance (q3w): Pemetrexed 500 mg/m² IV, Day 1 Pembrolizumab 200 mg IV, Day 1
• Cisplatin/Carboplatin and Pemetrexed plus Atezolizumab — DRUG
  Induction (Cycles 1-4, q3w): Atezolizumab 1200 mg IV, Day 1 Cisplatin 75 mg/m² IV or Carboplatin AUC 6 IV, Day 1 Pemetrexed 500 mg/m² IV, Day 1 Maintenance (q3w): Atezolizumab 1200 mg IV, Day 1 Pemetrexed 500 mg/m² IV, Day 1
• Carboplatin and Paclitaxel plus Atezolizumab and Bevacizumab — DRUG
  Induction (Cycles 1-4, q3w): Atezolizumab 1200 mg IV, Day 1 Bevacizumab 15 mg/kg IV, Day 1 Carboplatin AUC 6 IV, Day 1 Paclitaxel 175 or 200 mg/m² IV, Day 1 Maintenance (q3w): Atezolizumab 1200 mg IV, Day 1 Bevacizumab 15 mg/kg IV, Day 1
• Carboplatin and Nab-paclitaxel plus Atezolizumab — DRUG
  Induction (Cycles 1-4, q3w): Atezolizumab 1200 mg IV, Day 1 Carboplatin AUC 6 IV, Day 1 Nab-paclitaxel 100 mg/m² IV on Days 1, 8, and 15 Maintenance (q3w): Atezolizumab 1200 mg IV, Day 1
• Nogapendekin alfa inbakicept (NAI) + Nivolumab + Ipilimumab + Carboplatin + Nab-paclitaxel — DRUG
  Cycle length: 6 weeks Nogapendekin alfa inbakicept (NAI): 1.2 mg SC on Days 1, 15, and 29 of each cycle Nivolumab: 360 mg IV on Days 1 and 22 of each cycle Ipilimumab: 1 mg/kg IV on Day 1 of each cycle Carboplatin: AUC 6 IV on Days 1 and 22 of Cycle 1 only Nab-paclitaxel: 100 mg/m² IV on Days 1, 8, 15, 22, 29, and 36 of Cycle 1 only

Study Details

This is a phase 3, open-label, 4-cohort study (3 randomized cohorts and 1 single-arm cohort). Participants enrolled in each cohort will be treated as detailed below. Each study cohort will be analyzed separately. Treatment will continue for up to 2 years, or until the patient experiences confirmed progressive disease or unacceptable toxicity, withdraws consent, or if the investigator feels that it is no longer in the patient's best interest to continue treatment. Patients will be followed for disease progression, post-therapies, and survival through 24 months after the first dose of study drug.

Key Dates

Start date

May 18, 2018

Status verified

Apr 2026

Primary completion

Oct 13, 2025

Completion

Oct 13, 2025

Study Design

Enrollment

102 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort A (Experimental)
• Experimental: Cohort B (Experimental)
• Experimental: Cohort C (Experimental)
• Active Comparator: Cohort A (Control)
• Active Comparator: Cohort B (Control)
• Active Comparator: Cohort C (Control)
• Experimental: Cohort D (Experimental)

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: 24 Months ]

Locations (31)

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