NCT06956001 is a Phase 3 clinical trial of Firmonertinib Mesilate Tablets in EGFR, sponsored by Allist Pharmaceuticals, Inc..

Who is sponsoring NCT06956001?

NCT06956001 is sponsored by Allist Pharmaceuticals, Inc..

What drugs are being tested in NCT06956001?

Interventions in NCT06956001: Firmonertinib Mesilate Tablets, Pemetrexed Disodium for Injection, Cisplatin for injection, Carboplatin Injection.

What condition does NCT06956001 study?

NCT06956001 studies EGFR, NSCLC (Advanced Non-small Cell Lung Cancer).

Is NCT06956001 still recruiting?

NCT06956001 is currently recruiting now. Last updated 10 February 2026.

Last reviewed 2026-02-10 · How we verify

NCT06956001

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

A Phase III, Randomized, Multicentre, Open Label Study to Assess the Efficacy and Safety of Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients With EGFR PACC Mutation or EGFR l861q Mutation

Recruiting now Phase 3 Last updated 10 February 2026

What this trial tests

Phase 3 trial testing Firmonertinib Mesilate Tablets in EGFR in 300 participants. Currently enrolling.

Timeline

19 November 2024

Primary endpoint
1 December 2027

1 July 2028

Quick facts

Lead sponsor	Allist Pharmaceuticals, Inc.
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	300
Start date	19 November 2024
Primary completion	1 December 2027
Estimated completion	1 July 2028
Sites	2 locations across China

Drugs / interventions tested

Firmonertinib Mesilate Tablets — full drug profile →
Pemetrexed Disodium for Injection — full drug profile →
Cisplatin for injection — full drug profile →
Carboplatin Injection — full drug profile →

Conditions studied

EGFR — all drugs for EGFR →
NSCLC (Advanced Non-small Cell Lung Cancer) — all drugs for NSCLC (Advanced Non-small Cell Lung Cancer) →

Sponsor

Allist Pharmaceuticals, Inc. — full company profile →

Who can join

18 and older, any sex, with EGFR or NSCLC (Advanced Non-small Cell Lung Cancer). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Progression-free survival (PFS) assessed by the Independent Review Committee (BICR) according to RECIST v1.1.
Time frame: Up to 3 years
The time from the date of randomization to the date of first documentation of disease progression (assessed according to RECIST v1.1 criteria) or death from any cause, whichever occurred first.

Sponsor's own description

This study is a randomized, open, multicenter phase III clinical study, which aims to evaluate the efficacy and safety of firmonertinib mesylate compared with platinum based chemotherapy for patients with locally advanced or metastatic NSCLC who have not been treated with systemic antitumor therapy and carry EGFR PaCC mutation or EGFR l861q mutation. Eligible patients were stratified by EGFR mutation type and CNS metastasis at the time of enrollment. Approximately 300 patients would be randomly assigned 1:1 to receive either firmonertinib mesylate (240mg, orally on an empty stomach daily) or platinum containing dual agent chemotherapy.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Firmonertinib Mesilate Tablets

Trials testing the same drug.

NCT07182708 — High-Dose Firmonertinib Plus Bevacizumab as Neoadjuvant Therapy for Resectable EGFRm Stage II-IIIB NSCLC · Phase 2 · not yet recruiting

Other recruiting trials for EGFR

Currently open trials in the same condition.

NCT07128199 — A Study to Assess the Efficacy and Safety of Zipalertinib Versus Placebo for Adjuvant Treatment in Participants With Sta · Phase 3 · recruiting
NCT07303218 — The HER Project: HRD in EGFR-mutated NSCLC · active not recruiting
NCT06755684 — Neoadjuvant Befotertinib Combined Bevacizumab or Platinum-based Double Chemotherapy for Resectable Locally-advanced EGFR · Phase 2 · recruiting

Other Allist Pharmaceuticals, Inc. trials

Trials by the same sponsor.

NCT07010419 — A Study to Assess the Efficacy and Safety of Firmonertinib Versus Placebo for Adjuvant Treatment in Participants With St · Phase 3 · recruiting
NCT06416410 — JAB-21822 Combined With JAB-3312 Compared SOC in the First Line for Treatment of Advanced Non-small Cell Lung Cancer Wit · Phase 3 · recruiting
NCT06162169 — A Clinical Trial to Evaluate JAB-21822 Drug-drug Interactions in Healthy Subjects · Phase 1 · completed
NCT06008288 — A Phase II Study Evaluating JAB-21822 Monotherapy in Adult Patients With Pancreatic Cancer and Other Solid Tumors Harbor · Phase 2 · recruiting
NCT05920941 — Mass Balance Study of [14C]JAB-21822 · Phase 1 · completed

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 NCT06956001 (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 Allist Pharmaceuticals, Inc.
Last refreshed: 10 February 2026

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/NCT06956001.

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