NCT05990127 is a Phase 3 clinical trial of AK104 in Locally Advanced or Metastatic NSCLC, sponsored by Akeso.

Who is sponsoring NCT05990127?

NCT05990127 is sponsored by Akeso.

What drugs are being tested in NCT05990127?

Interventions in NCT05990127: AK104, Tislelizumab, carboplatin, Pemetrexed, Paclitaxel.

What condition does NCT05990127 study?

NCT05990127 studies Locally Advanced or Metastatic NSCLC.

Is NCT05990127 still recruiting?

NCT05990127 is currently not yet recruiting. Last updated 14 August 2023.

Last reviewed 2023-08-14 · How we verify

NCT05990127

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of AK104/Tislelizumab With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer

Not yet recruiting Phase 3 Last updated 14 August 2023

What this trial tests

Phase 3 trial testing AK104 in Locally Advanced or Metastatic NSCLC in 642 participants. Not yet recruiting.

Timeline

14 November 2023

Primary endpoint
5 August 2025

28 November 2026

Quick facts

Lead sponsor	Akeso
Phase	Phase 3
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	642
Start date	14 November 2023
Primary completion	5 August 2025
Estimated completion	28 November 2026
Sites	62 locations across China

Drugs / interventions tested

AK104
Tislelizumab (TISLELIZUMAB) — full drug profile →
carboplatin
Pemetrexed — full drug profile →
Paclitaxel — full drug profile →

Conditions studied

Locally Advanced or Metastatic NSCLC — all drugs for Locally Advanced or Metastatic NSCLC →

Sponsor

Akeso — full company profile →

Who can join

18 and older, any sex, with Locally Advanced or Metastatic NSCLC. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a randomized, double-blind, phase III clinical study to compare the efficacy and safety of AK104 combined chemotherapy versus Tislelizumab combined chemotherapy in first-line treatment of Locally advanced or metastatic NSCLC with PD-L1 TPS \< 1%.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of AK104

Trials testing the same drug.

NCT07052253 — A Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet for Advanced HCC. · Phase 2 · recruiting
NCT06946836 — Comparison of Neoadjuvant Cadonilimab Versus Chemotherapy Combined With PD-1 in the Treatment of Resectable Non-Small Ce · Phase 2 · not yet recruiting
NCT06560112 — An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent Ovarian Cancer · Phase 2 · recruiting
NCT06542549 — Efficacy and Safety of AK104 (PD-1/CTLA-4 Bispecial Antibody) Combined With Chemotherapy for Neoadjuvant Treatment of Ad · Phase 3 · not yet recruiting
NCT06371157 — A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With · Phase 3 · recruiting

Other recruiting trials for Locally Advanced or Metastatic NSCLC

Currently open trials in the same condition.

NCT06461156 — A Study of HS-10504 in Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC) · Phase 1 · recruiting
NCT04143607 — ASK120067 Versus Gefitinib as First-line Treatment for EGFRm Locally Advanced or Metastatic NSCLC · Phase 3 · active not recruiting
NCT03969823 — Whole Genomic Landscape of Advanced EGFR-mutant NSCLC · NA · active not recruiting

Other Akeso trials

Trials by the same sponsor.

NCT07449780 — A Study of AK104 (SC) in Combination With Oxaliplatin and Capecitabine (XELOX) Versus AK104 (IV) in Combination With XEL · Phase 3 · not yet recruiting
NCT07412613 — Neoadjuvant/Adjuvant AK104 in Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer · Phase 3 · not yet recruiting
NCT07357220 — A Study of AK112 in Combination With VG2025 in Colorectal Cancer With Liver Metastases · Phase 1, PHASE2 · not yet recruiting
NCT07436234 — A Study to Evaluate the Efficacy and Safety of AK139 in Participants With Seasonal Allergic Rhinitis · Phase 2 · not yet recruiting
NCT07436221 — A Study to Evaluate the Efficacy and Safety of AK139 in Participants With Asthma · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05990127 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Akeso
Last refreshed: 14 August 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05990127.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing