- |||||||||| Real-world outcomes (RWO) of oral MET-inhibition in EGFR MET-amplified (MET-amp) NSCLC (Foyer) - Feb 5, 2026 - Abstract #ELCC2026ELCC_345;
MET-treated patients with MET:CEP7 ratio ?2 (n=10) had similar responses to those with ratio <2 (n=5) (mOS 45.4 vs 49.8m, mPFS on MET-i 8.2 v 6.8m, DOR 8.9 v 6.2m).Conclusions Combination EGFR and MET inhibition benefited both denovo Met-amp and post TKI MET resistant EGFR patients. Oral combinations remain an important option for patients.
- |||||||||| nazartinib (EGF816) / Novartis
Trial completion date, Trial primary completion date: Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC (clinicaltrials.gov) - Jan 16, 2026
P1, N=105, Active, not recruiting,
Oral combinations remain an important option for patients. Trial completion date: Mar 2026 --> Oct 2026 | Trial primary completion date: Mar 2026 --> Oct 2026
- |||||||||| nazartinib (EGF816) / Novartis
Trial completion date, Trial primary completion date: Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC (clinicaltrials.gov) - Aug 26, 2025
P1, N=105, Active, not recruiting,
Active, not recruiting --> Terminated; Business reasons and not due to any safety concerns Trial completion date: Oct 2025 --> Mar 2026 | Trial primary completion date: Oct 2025 --> Mar 2026
- |||||||||| batoprotafib (TNO155) / Novartis
Trial completion date, Trial primary completion date, First-in-human: Dose Finding Study of TNO155 in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - Jul 7, 2025
P1, N=227, Active, not recruiting,
Trial completion date: Oct 2025 --> Mar 2026 | Trial primary completion date: Oct 2025 --> Mar 2026 Trial primary completion date: Nov 2025 --> Jul 2025 | Trial completion date: Nov 2025 --> Jul 2025
- |||||||||| nazartinib (EGF816) / Novartis
Trial termination: A Study of EGF816 and Gefitinib in TKI-na (clinicaltrials.gov) - Jun 10, 2025
P2, N=11, Terminated,
Trial primary completion date: Nov 2025 --> Jul 2025 | Trial completion date: Nov 2025 --> Jul 2025 Active, not recruiting --> Terminated; Slow accrual
- |||||||||| batoprotafib (TNO155) / Novartis
Trial completion date, Trial primary completion date, First-in-human: Dose Finding Study of TNO155 in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - Feb 27, 2025
P1, N=227, Active, not recruiting,
Trial completion date: Apr 2025 --> Oct 2025 | Trial primary completion date: Apr 2025 --> Oct 2025 Trial completion date: May 2025 --> Nov 2025 | Trial primary completion date: May 2025 --> Nov 2025
- |||||||||| nazartinib (EGF816) / Novartis
Trial completion date, Trial primary completion date: Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC (clinicaltrials.gov) - Sep 20, 2024
P1, N=105, Active, not recruiting,
Trial completion date: May 2025 --> Nov 2025 | Trial primary completion date: May 2025 --> Nov 2025 Trial completion date: Dec 2024 --> Apr 2025 | Trial primary completion date: Dec 2024 --> Apr 2025
- |||||||||| nazartinib (EGF816) / Novartis
Trial completion date: A Study of EGF816 and Gefitinib in TKI-na (clinicaltrials.gov) - Jul 29, 2024
P2, N=11, Active, not recruiting,
The efficiency of utilizing different in silico software approaches to conserve resources and reduce effort was proved by the outcomes attained from in vitro incubation experiments and the use of NZT in silico software. Trial completion date: Jun 2024 --> Dec 2024
- |||||||||| batoprotafib (TNO155) / Novartis
Trial completion date, Trial primary completion date, First-in-human: Dose Finding Study of TNO155 in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - Jan 2, 2024
P1, N=255, Recruiting,
Recruiting --> Completed | Trial completion date: Apr 2023 --> Nov 2023 Trial completion date: Oct 2024 --> Apr 2025 | Trial primary completion date: Oct 2024 --> Apr 2025
- |||||||||| batoprotafib (TNO155) / Novartis
Trial completion date, Trial primary completion date, First-in-human: Dose Finding Study of TNO155 in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - Jun 29, 2023
P1, N=255, Recruiting,
Trial completion date: Mar 2024 --> Sep 2024 | Trial primary completion date: Mar 2024 --> Sep 2024 Trial completion date: Apr 2024 --> Aug 2024 | Trial primary completion date: Feb 2024 --> Aug 2024
- |||||||||| nazartinib (EGF816) / Novartis
Trial completion date, Trial primary completion date: A Study of EGF816 and Gefitinib in TKI-na (clinicaltrials.gov) - May 31, 2023
P2, N=11, Active, not recruiting,
Trial completion date: Apr 2024 --> Aug 2024 | Trial primary completion date: Feb 2024 --> Aug 2024 Trial completion date: Oct 2025 --> Jun 2024 | Trial primary completion date: Oct 2022 --> Dec 2023
- |||||||||| nazartinib (EGF816) / Novartis
Trial completion date, Trial primary completion date: Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC (clinicaltrials.gov) - Jun 30, 2022
P1, N=105, Active, not recruiting,
Trial completion date: Jul 2025 --> Nov 2021 | Recruiting --> Terminated | Trial primary completion date: Jul 2025 --> Nov 2021; Company decision Trial completion date: Nov 2022 --> Sep 2023 | Trial primary completion date: Nov 2022 --> Sep 2023
- |||||||||| nazartinib (EGF816) / Novartis, Mekinist (trametinib) / Novartis, BeOne Medicines, Tagrisso (osimertinib) / AstraZeneca
Enrollment open, Trial completion date, Trial primary completion date: EATON: EGF816 and Trametinib in Patients With Non-small Cell Lung Cancer Harboring Activating EGFR Mutations (clinicaltrials.gov) - Jun 16, 2022
P1, N=24, Recruiting,
Trial completion date: Nov 2022 --> Sep 2023 | Trial primary completion date: Nov 2022 --> Sep 2023 Unknown status --> Recruiting | Trial completion date: Nov 2021 --> Apr 2023 | Trial primary completion date: Nov 2020 --> Sep 2022
- |||||||||| nazartinib (EGF816) / Novartis, canertinib (CI-1033) / Pfizer, Vizimpro (dacomitinib) / Pfizer
Journal: New C2- and N3-Modified Thieno[2,3-d]Pyrimidine Conjugates with Cytotoxicity in the Nanomolar Range. (Pubmed Central) - Apr 13, 2022
Based on the analysis of the structure-activity relationship, the observed trends in the cytotoxicity could be related to the lipophilicity and the topological polar surface area of the tested compounds. The docking study on the potential of the new thieno[2,3-d]pyrimidine-4-ones to interact with mutant B-Raf showed that the compounds might be able to stabilize the enzyme in its inactive form.
- |||||||||| Journal, PARP Biomarker: Studies on ligand-based pharmacophore modeling approach in identifying potent future EGFR inhibitors. (Pubmed Central) - Apr 1, 2022
Results deduced by in silico work in the current study may be corroborated biologically in the future. The current work, therefore, provides ample opportunity for computational and medicinal chemists to work in allied areas to facilitate the design and development of novel and more efficacious EGFR inhibitors for future experimental studies.
- |||||||||| batoprotafib (TNO155) / Novartis
Trial completion date, Trial primary completion date, First-in-human: Dose Finding Study of TNO155 in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - Mar 21, 2022
P1, N=255, Recruiting,
The current work, therefore, provides ample opportunity for computational and medicinal chemists to work in allied areas to facilitate the design and development of novel and more efficacious EGFR inhibitors for future experimental studies. Trial completion date: Aug 2023 --> Feb 2024 | Trial primary completion date: Aug 2023 --> Feb 2024
- |||||||||| Review, Journal: Mechanisms and management of 3rd‑generation EGFR‑TKI resistance in advanced non‑small cell lung cancer (Review). (Pubmed Central) - Jan 29, 2022
The mechanisms of acquired resistance mainly include an altered EGFR signaling pathway (EGFR tertiary mutations and amplification), activation of aberrant bypassing pathways (hepatocyte growth factor receptor amplification, human epidermal growth factor receptor 2 amplification and aberrant insulin‑like growth factor 1 receptor activation), downstream pathway activation (RAS/RAF/MEK/ERK and PI3K/AKT/mTOR) and histological/phenotypic transformations (SCLC transformation and epithelial‑mesenchymal transition). The combination of targeted therapies is a promising strategy to treat osimertinib‑resistant patients, and multiple clinical studies on novel combined therapies are ongoing.
- |||||||||| nazartinib (EGF816) / Novartis
Enrollment closed: A Study of EGF816 and Gefitinib in TKI-na (clinicaltrials.gov) - Jan 24, 2022
P2, N=11, Active, not recruiting,
The combination of targeted therapies is a promising strategy to treat osimertinib‑resistant patients, and multiple clinical studies on novel combined therapies are ongoing. Recruiting --> Active, not recruiting
- |||||||||| nazartinib (EGF816) / Novartis
Enrollment closed, Enrollment change: Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC (clinicaltrials.gov) - Jun 23, 2021
P1, N=105, Active, not recruiting,
Completed --> Active, not recruiting | Trial completion date: Nov 2020 --> Jul 2025 | Trial primary completion date: Nov 2020 --> Jul 2025 Recruiting --> Active, not recruiting | N=157 --> 105
- |||||||||| Tagrisso (osimertinib) / AstraZeneca
Review, Journal: Beyond osimertinib: The development of 3-generation EGFR Tyrosine Kinase Inhibitors. (Pubmed Central) - May 25, 2021
P3
Additionally, we summarized the results of clinical trials that previously reported third-generation EGFR TKIs (rociletinib, olmutinib, nazartinib, maverlertinib) including phase 3 results of rociletinib and naquotinib. We further profiled the next-generation combination clinical trial design of third-generation EGFR TKIs including FLAURA2 (NCT04035486), MARIPOSA (NCT04487080), ACROSS1 (NCT04500704) and ACROSS2 (NCT04500717).
- |||||||||| nazartinib (EGF816) / Novartis
Trial completion date, Trial primary completion date: Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC (clinicaltrials.gov) - May 5, 2021
P1, N=157, Recruiting,
We further profiled the next-generation combination clinical trial design of third-generation EGFR TKIs including FLAURA2 (NCT04035486), MARIPOSA (NCT04487080), ACROSS1 (NCT04500704) and ACROSS2 (NCT04500717). Trial completion date: Mar 2024 --> Nov 2022 | Trial primary completion date: Mar 2024 --> Nov 2022
- |||||||||| TNO-155 / Novartis
[VIRTUAL] Initial results from a dose finding study of TNO155, a SHP2 inhibitor, in adults with advanced solid tumors. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_808;
P1, P1/2
The optimal dose using several schedules is still under evaluation . Studies of TNO155 in combination with other agents, including nazartinib (mutant-selective EGFR inhibitor[i]), adagrasib (KRAS G12Ci), spartalizumab (anti-PD-1 antibody), ribociclib (CDK4/6i), and dabrafenib (BRAFi) with LTT462 (ERKi), are ongoing (NCT03114319, NCT04330664, NCT04000529, NCT04294160).
- |||||||||| Trial completion: A Study of PDR001 in Combination With CJM112, EGF816, Ilaris (clinicaltrials.gov) - Apr 28, 2021
P1, N=289, Completed,
Studies of TNO155 in combination with other agents, including nazartinib (mutant-selective EGFR inhibitor[i]), adagrasib (KRAS G12Ci), spartalizumab (anti-PD-1 antibody), ribociclib (CDK4/6i), and dabrafenib (BRAFi) with LTT462 (ERKi), are ongoing (NCT03114319, NCT04330664, NCT04000529, NCT04294160). Active, not recruiting --> Completed
- |||||||||| batoprotafib (TNO155) / Novartis
Trial completion date, Trial primary completion date, First-in-human: Dose Finding Study of TNO155 in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - Feb 24, 2021
P1, N=255, Recruiting,
Active, not recruiting --> Completed Trial completion date: Aug 2022 --> Aug 2023 | Trial primary completion date: Aug 2022 --> Aug 2023
- |||||||||| nazartinib (EGF816) / Novartis
Trial completion date, Trial primary completion date: Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC (clinicaltrials.gov) - Jan 6, 2021
P1, N=157, Recruiting,
Trial completion date: Aug 2022 --> Aug 2023 | Trial primary completion date: Aug 2022 --> Aug 2023 Trial completion date: May 2022 --> Mar 2024 | Trial primary completion date: May 2022 --> Mar 2024
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