NCT04797702

Glumetinib Combined With Toripalimab in the Treatment of Relapsed or Metastatic Non-small Cell Lung Cancer.

A Open-label, Multi-center Phase Ib/II Clinical Study of Glumetinib Combined With Toripalimab in Patients With Relapsed or Metastatic Non-small Cell Lung Cancer Who Have Failed or Are Intolerant to Standard Therapy.

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 67 (estimated)
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter Phase Ib/II registration clinical study, consisting of two parts: the Phase Ib dose-climbing study and the Phase II efficacy exploration study. Phase Ib : Phase Ib is a multicenter, single-arm study evaluating the safety, tolerability, and preliminary efficacy of SCC244 combined with Toripalimab in patients with advanced relapsed or metastatic non-small cell lung cancer who have failed standard therapy.At the start of the study, MTPI2 was used to guide toxicity monitoring and dose climbing in combination with Toripalimab (240mg intravenous every 3 weeks), with 5 subjects planned to be enrolled in each dose group.The SMC will decide whether to add the new dose level and sample size based on the latest study data available.The MTD or recommended phase II dose (RP2D) will be determined during the phase Ib study on the basis of the latest availablestudy data, and the phase II study will commence once the MTD or recommended phase II dose (RP2D) is confirmed. Phase II: Phase II is a multicenter, open-label, single-arm study evaluating the efficacy and safety of a recommended dose of glumetinib combined with Toripalimab in patients with relapsed, metastatic non-small cell lung cancer who have failed standard therapy.The SMC determined the dose group for the Phase II study based on the safety and initial efficacy data of the Phase Ib subjects.Approximately 62 evaluable subjects will be enrolled, with the recommended dose of glutmetinib once daily and Toripalimab 240mg every 3 weeks. Every 21 days is a treatment cycle until the subject develops disease progression,intolerable toxicity, has used JS001 for 2 years, the informed consent is withdrawn, the investigator considers that the subject should not continue the medication, lost to follow-up, death occurs, or the study is terminated, whichever comes first.

Conditions

• Relapsed or Metastatic Non-small Cell Lung Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Glumetinib combined with Toripalimab	Ib：All enrolled subjects received Glumetinib combined with Toripalimab on a 21-day cycle, starting with 200mg/ day continuous Glumetinib and 240mg/ 3 weeks Toripalimab. II：The SMC will determine the dose group for the Phase II study based on the safety and initial efficacy data of the Phase Ib subjects. Approximately 62 evaluable subjects will be enrolled in the study to receive the recommended dose of Glumetinib once daily and continuous treatment with Toripalimab 240mg every 3 weeks.

Timeline

• Start date: 2021-04-15
• Primary completion: 2023-07-31
• Completion: 2024-02-26
• First posted: 2021-03-15
• Last updated: 2021-03-15

Locations

1 site across 1 country: China