Randomized, Open-Label, Phase 3 Clinical Trial of N-803 Plus Tislelizumab and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer who Have Acquired Resistance to Immune Checkpoint Inhibitor Therapy

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521221-32-00

Acronym

ResQ201A-NSCLC

Enrollment

110

Registered

2025-08-26

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced or Metastatic Non-Small Cell Lung Cancer

Brief summary

Overall Survival (OS)

Detailed description

Efficacy - Compare immune DCR (iDCR), immune progression-free survival (iPFS), immune overall response rate (iORR), and immune duration of response (iDOR) as measured using immune Response Evaluation Criteria in Solid Tumors (iRECIST) between the experimental and control arms. Safety - Compare safety between the experimental and control arms.

Interventions

DRUGN-803 (NAI)

DRUGDocetaxel Seacross 20 mg/ml concentrado para solução para perfusão

DRUGTislelizumab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall Survival (OS)	—

Secondary

Measure	Time frame
Efficacy - Compare immune DCR (iDCR), immune progression-free survival (iPFS), immune overall response rate (iORR), and immune duration of response (iDOR) as measured using immune Response Evaluation Criteria in Solid Tumors (iRECIST) between the experimental and control arms. Safety - Compare safety between the experimental and control arms.	—

Countries

Germany, Hungary

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026