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Maleic acid

Enzyme Inhibitors

Participants will receive sutetinib maleate capsule taken orally with (preferred) or without food, at the dose directed by the Investigators, 28 days for a cycle.

Sutetinib Maleate Capsule

Xiaoyang Xia

Dawei Zhang

The main objective of the study will be to evaluate the efficacy of sutetinib maleate capsules in participants with locally advanced or metastatic non-small cell lung cancer NSCLC (uncommon EGFR mutations only).

Sutetinib is an investigational irreversible EGFR tyrosine kinase inhibitor. EGFR is a gene that makes a protein that is involved in cell growth and cell survival. Mutated (changed) forms of the EGFR gene and protein have been found in some types of cancer, including non-small cell lung cancer. These changes may cause cancer cells to grow and spread in the body. The purpose of this study is to explore how effective Sutetinib maleate capsules are for the treatment of patients with locally advanced or metastatic NSCLC with uncommon EGFR mutations.

A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC

A Multicenter, Open-label, Phase 2 Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Uncommon EGFR Mutations Only)

Ratio of participants who do not have objective tumor progression or have not died 1 year after the first dose of IP.

Ratio of surviving participants 1 year after the first dose of IP.

Teligene US

Study drug to be taken orally with or without food (with food preferred) for up to13 cycles

Heather Lyon

Anthony Lam, MD, MHS

Katherina Scilla, M.D.

Xiuning Le, M.D., Ph.D.

This is a Phase 2b, multicenter, open-label study to evaluate the safety and efficacy of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Non-resistant Uncommon EGFR Mutations Only, Including L861Q, G719X, and/or S768I)

Sutetinib is an investigational irreversible EGFR tyrosine kinase inhibitor. EGFR is a gene that makes a protein that is involved in cell growth and cell survival. Mutated (changed) forms of the EGFR gene and protein have been found in some types of cancer, including non-small cell lung cancer. These changes may cause cancer cells to grow and spread in the body. The purpose of this study is to explore how effective Sutetinib maleate capsules are for the treatment of patients with locally advanced or metastatic NSCLC with non-resistant uncommon EGFR mutations

Study to Evaluate Sutetinib Maleate Capsule in Locally Advanced or Metastatic Non-small Cell Lung Cancer

A Multicenter, Open-label, Phase IIb Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Non-resistant Uncommon EGFR Mutations Only, Including L861Q, G719X, and/or S768I)

Objective response rate (ORR) assessed by IRC

Safety and tolerability as determined by the incidence of adverse events (AEs), including severe AEs and serious AEs(SAEs)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC	NCT06010329	Non-small Cell ...	Sutetinib Malea...	18 Years - 75 Years	Teligene US
Study to Evaluate Sutetinib Maleate Capsule in Locally Advanced or Metastatic Non-small Cell Lung Cancer	NCT05168566	Non-small Cell ...	Sutetinib Malea...	18 Years -	Teligene US
A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC	NCT06010329	Non-small Cell ...	Sutetinib Malea...	18 Years - 75 Years	Teligene US
A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC	NCT06010329	Non-small Cell ...	Sutetinib Malea...	18 Years - 75 Years	Teligene US

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