NCT03452150 is a Phase 1 clinical trial of D-0316 in Advanced Non Small Cell Lung Cancer, sponsored by InventisBio Co., Ltd.

Who is sponsoring NCT03452150?

NCT03452150 is sponsored by InventisBio Co., Ltd.

What drugs are being tested in NCT03452150?

Interventions in NCT03452150: D-0316.

What condition does NCT03452150 study?

NCT03452150 studies Advanced Non Small Cell Lung Cancer.

Is NCT03452150 still recruiting?

NCT03452150 is currently completed. Last updated 25 April 2023.

Last reviewed 2023-04-25 · How we verify

NCT03452150

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

D-0316 First Time in Patients Ascending Dose Study

Completed Phase 1 Last updated 25 April 2023

What this trial tests

Phase 1 trial testing D-0316 in Advanced Non Small Cell Lung Cancer in 84 participants. Completed in 31 December 2020.

Timeline

3 January 2018

Primary endpoint
28 August 2020

31 December 2020

Quick facts

Lead sponsor	InventisBio Co., Ltd
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	84
Start date	3 January 2018
Primary completion	28 August 2020
Estimated completion	31 December 2020
Sites	3 locations across China

Drugs / interventions tested

D-0316

Conditions studied

Advanced Non Small Cell Lung Cancer — all drugs for Advanced Non Small Cell Lung Cancer →

Sponsor

InventisBio Co., Ltd — full company profile →

Who can join

Adults 18 to 75, any sex, with Advanced Non Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase 1 open label multicentre study of D-0316 administered orally in patients with advanced NSCLC who have progressed following prior therapy with an EGFR-TKI (Epidermal Growth Factor Receptor tyrosine kinase inhibitor agent). This is the first time this drug has ever been tested in patients, and so it will help to understand safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of ascending doses of D-0316.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Structural Insight and Development of EGFR Tyrosine Kinase Inhibitors.
Amelia T, Kartasasmita RE, Ohwada T, Tjahjono DH. · · 2022 · cited 83× · PMID 35164092 · DOI 10.3390/molecules27030819
Phase I Trial of a Third Generation EGFR Mutant-Selective Inhibitor (D-0316) in Patients with Advanced Non-Small Cell Lung Cancer.
Jian H, Wang K, Cheng Y, Ding L, et al · · 2022 · cited 9× · PMID 35274722 · DOI 10.1093/oncolo/oyab007
Safety, pharmacokinetics, and efficacy of BPI-15086 in patients with EGFR T790M-mutated advanced non-small-cell lung cancer: results from a phase I, single-arm, multicenter study.
Xing P, Zheng X, Wang Y, Chu T, et al · · 2022 · PMID 35526510 · DOI 10.1016/j.esmoop.2022.100473

Verify or expand the search:

Other trials of D-0316

Trials testing the same drug.

NCT03861156 — D-0316 in Patients With EGFR Positive Non Small Cell Lung Cancer · Phase 2 · completed

Other recruiting trials for Advanced Non Small Cell Lung Cancer

Currently open trials in the same condition.

NCT06908993 — Tepotinib vs Standard Treatment in Patients With Advanced MET Exon 14 Mutated Non-Small Cell Lung Cancer Previously Trea · Phase 3 · recruiting
NCT05777603 — Study of Aerosolized Antibiotics and Pembrolizumab in Advanced Non-small Cell Lung Cancer · Phase 1 · recruiting
NCT06107374 — Imaging Advanced NSCLC Patients Undergoing PD-1/PD-L1 Directed Therapy Using [18F]-FARAG · Phase 2 · recruiting
NCT06406166 — Lifei Xiaoji Wan in Treatment of Advanced NSCLC · NA · recruiting
NCT04886401 — Retrospective Observational Study on Prediction of Response to PD-1 Immunotherapy in Patients with NSCLC · recruiting

Other InventisBio Co., Ltd trials

Trials by the same sponsor.

NCT07411742 — Mass Balance Study of [14C] D-2570 · Phase 1 · not yet recruiting
NCT07311200 — A Study of D-2570 in Patients With Active Systemic Lupus Erythematosus (SLE) · Phase 2 · not yet recruiting
NCT07326813 — A Clinical Study to Evaluate the Efficacy and Safety of D-2570 in the Treatment of Moderate to Severe Plaque Psoriasis. · Phase 3 · not yet recruiting
NCT07315061 — A Phase II Study to Evaluate the Efficacy and Safety of D-2570 in Subjects With Active Psoriatic Arthritis · Phase 2 · recruiting
NCT07130604 — Evaluate the Efficacy and Safety of D-2570 in Subjects With Moderate to Severe Plaque Psoriasis · Phase 3 · 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 NCT03452150 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by InventisBio Co., Ltd
Last refreshed: 25 April 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/NCT03452150.

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