NCT03861156

D-0316 in Patients With EGFR Positive Non Small Cell Lung Cancer

Completed Phase 2 Last updated 9 April 2024

What this trial tests

Phase 2 trial testing D-0316 in Solid Tumor in 290 participants. Completed in 31 May 2023.

Timeline

28 February 2019

Primary endpoint
15 August 2021

31 May 2023

Quick facts

Lead sponsor	InventisBio Co., Ltd
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	290
Start date	28 February 2019
Primary completion	15 August 2021
Estimated completion	31 May 2023
Sites	1 location across China

Drugs / interventions tested

• D-0316

Conditions studied

• Solid Tumor — all drugs for Solid Tumor →
• NSCLC — all drugs for NSCLC →
• EGFR T790M — all drugs for EGFR T790M →

Sponsor

InventisBio Co., Ltd — full company profile →

Who can join

18 and older, any sex, with Solid Tumor or NSCLC. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of D-0316 in Patients with Locally Advanced/Metastatic Non Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours are Epidermal Growth Factor Receptor Mutation and T790M Mutation Positive

Publications & conference data

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

1. Therapeutic advances of targeting receptor tyrosine kinases in cancer.
   Tomuleasa C, Tigu AB, Munteanu R, Moldovan CS, et al · · 2024 · cited 133× · PMID 39138146 · DOI 10.1038/s41392-024-01899-w
2. Acquired resistance to third-generation EGFR-TKIs and emerging next-generation EGFR inhibitors.
   Du X, Yang B, An Q, Assaraf YG, et al · · 2021 · cited 101× · PMID 34557754 · DOI 10.1016/j.xinn.2021.100103
3. 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
4. Efficacy and Safety of Befotertinib (D-0316) in Patients With EGFR T790M-Mutated NSCLC That Had Progressed After Prior EGFR Tyrosine Kinase Inhibitor Therapy: A Phase 2, Multicenter, Single-Arm, Open-Label Study.
   Lu S, Zhang Y, Zhang G, Zhou J, et al · · 2022 · cited 23× · PMID 35724798 · DOI 10.1016/j.jtho.2022.06.002
5. Resistance of Lung Cancer to EGFR-Specific Kinase Inhibitors: Activation of Bypass Pathways and Endogenous Mutators.
   Marrocco I, Yarden Y. · · 2023 · cited 10× · PMID 37894376 · DOI 10.3390/cancers15205009
6. Strategies Beyond 3rd EGFR-TKI Acquired Resistance: Opportunities and Challenges.
   Zhou X, Zeng L, Huang Z, Ruan Z, et al · · 2025 · cited 9× · PMID 40322930 · DOI 10.1002/cam4.70921
7. 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
8. Metastatic brain tumors: from development to cutting-edge treatment.
   Tanzhu G, Chen L, Ning J, Xue W, et al · · 2025 · cited 8× · PMID 39712454 · DOI 10.1002/mco2.70020