ResQ201A: Clinical Trial Of N-803 Plus TISLELIZUMAB And DOCETAXEL Versus DOCETAXEL Monotherapy In Participants With Advanced Or Metastatic Non-Small Cell Lung Cancer

Phase 3

Recruiting

• Conditions: NSCLC Stage IV
• Interventions: Drug: N-803; Drug: Tislelizumab; Drug: Docetaxel

• Registration Number: NCT06745908
• Lead Sponsor: ImmunityBio, Inc.

Brief Summary

This is a randomized, open-label, phase 3 clinical trial to compare the efficacy and safety of N-803 plus tislelizumab and docetaxel (experimental arm) versus docetaxel monotherapy (control arm). Enrolled participants will be randomized 2:1 to treatment in the experimental arm or the control arm. Participant randomization will be stratified by geographical region (North America vs Europe vs ASIA vs Other), NSCLC histology (squamous vs nonsquamous), and actionable genomic alteration (AGA); (epidermal growth factor receptor \[EGFR\]/anaplastic lymphoma kinase \[ALK\] vs OTHER AGA vs No AGA).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-17
• Study First Posted: 2024-12-20
• Study Start: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-06
• Primary Completion: 2028-09
• Study Completion: 2029-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 460

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Arm	Tislelizumab	The treatment regimen for the experimental arm will be as follows. Agents are to be administered in the order listed (eg, on day 1 experimental arm \[cycles 1 and 2\], administer N-803, followed tislelizumab and then followed by docetaxel).
Experimental Arm	Docetaxel	The treatment regimen for the experimental arm will be as follows. Agents are to be administered in the order listed (eg, on day 1 experimental arm \[cycles 1 and 2\], administer N-803, followed tislelizumab and then followed by docetaxel).
Control Arm	Docetaxel	The control arm treatment regimen will consist of repeated 3-week cycles with a ± 3-day window for each visit of Docetaxel 75 mg/m2 IV.
Experimental Arm	N-803	The treatment regimen for the experimental arm will be as follows. Agents are to be administered in the order listed (eg, on day 1 experimental arm \[cycles 1 and 2\], administer N-803, followed tislelizumab and then followed by docetaxel).

Primary Outcome Measures

Name	Time	Method
Compare Overall Survival between the experimental and control arms	Approximately 12 months

Trial Locations

Locations (2)

OPN Healthcare INC; 🇺🇸 Glendale, California, United States

OPN Healthcare INC/ Cancer and Blood Specialty Clinic; 🇺🇸 Los Alamitos, California, United States