Nogapendekin Alfa Inbakicept for Advanced Non-Small Cell Lung Cancer

Summary

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.

Conditions

• Non Small Cell Lung Cancer

Interventions

DRUG

NAI + Pembrolizumab

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

DRUG

NAI + Nivolumab + Ipilimumab

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

DRUG

NAI + Pembrolizumab + Carboplatin + Nab-paclitaxel or Paclitaxel

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

DRUG

Cisplatin/Carboplatin + Pemetrexed + Pembrolizumab + NAI

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

DRUG

Cisplatin/Carboplatin + Pemetrexed + Atezolizumab + NAI

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

DRUG

Carboplatin + Paclitaxel + Atezolizumab + Bevacizumab + NAI

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

DRUG

Carboplatin + Nab-paclitaxel + Atezolizumab + NAI

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

DRUG

Pembrolizumab

Pembrolizumab 200 mg IV, Day 1 every 3 weeks

DRUG

Pembrolizumab + Carboplatin + Nab-paclitaxel or Paclitaxel

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

Drug: Cisplatin/Carboplatin and Pemetrexed plus Pembrolizumab

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

DRUG

Cisplatin/Carboplatin and Pemetrexed plus Atezolizumab

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

DRUG

Carboplatin and Paclitaxel plus Atezolizumab and Bevacizumab

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

DRUG

Carboplatin and Nab-paclitaxel plus Atezolizumab

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

DRUG

Nogapendekin alfa inbakicept (NAI) + Nivolumab + Ipilimumab + Carboplatin + Nab-paclitaxel

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

Sponsors & Collaborators

• ImmunityBio, Inc.

  lead INDUSTRY

Principal Investigators

• Jayson Garmizo · Associate Director, Clinical Operations

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-05-18

Primary Completion

2025-10-13

Completion

2025-10-13

FDA Drug

Yes

Countries

• United States

Study Locations