Trametinib Plus Anlotinib Combined With Tislelizumab in KRAS-mutant NSCLC

Status Not yet recruiting

Clinical Trial Summary

Lung cancer is the most common cause of cancer-related death worldwide. Approximately 85% to 90% of lung cancer cases are non-small cell lung cancer (NSCLC), of which KRAS is one of the most common driver genes, occurring in 25-30% of lung adenocarcinomas and 3-5% of squamous cell carcinomas. KRAS-mutant NSCLC had been considered undruggable in past decades. This research sought to address a significant challenge in treating NSCLC with KRAS mutations, which are notoriously difficult to target effectively. Here, we proposal that the combined use of anlotinib and trametinib combined with tislelizumab may form an effective strategy for the treatment of KRAS-mutant NSCLC patients.

Clinical Trial Description

This is a phase 1/2, open-label, multi-center study aimed at exploring the potential therapeutic efficacy of tislelizumab (intravenous), trametinib (oral) and anlotinib (oral) in KRAS-mutant advanced non-small cell lung cancer patients. The primary objectives were safety, recommended phase 2 dose (RP2D) in Phase I and PFS in Phase II. The secondary aim of the study is to evaluate the progression-free survival (PFS), overall survival (OS), adverse events (AEs), and duration of response (DOR) of the combined strategy in these patients. If the RP2D is reached in Phase I, Phase II will be started; if RP2D is not reached in Phase I, Phase II will not be started. The number of subjects is determined according to the actual situation of dose climbing. All patients will be of histo- and/or cytopathology confirmed. Determination of the KRAS mutation type will be performed in the pathological department of Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine. Both ARMS method or targeted sequencing are acceptable. It is not acceptable for subjects with the presence of other driver gene mutation. All eligible subjects must have adequate renal, hepatic, and hematologic function, as defined in "inclusion criteria". ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06456138
Study type	Interventional
Source	Shanghai Chest Hospital
Contact	Tianqing Chu, MD, PhD
Phone	+86 13661775640
Email	ctqxkyy@163.com
Status	Not yet recruiting
Phase	Phase 1/Phase 2
Start date	July 1, 2024
Completion date	December 31, 2028

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04575831` - Exercise, Nutrition, and Palliative Care in Advanced Lung Cancer (ENPAL)	N/A
Completed	`NCT04069494` - Descriptors and Predictors of Burden and Information Needs
Terminated	`NCT03330834` - CAR-T Cell Immunotherapy for Advanced Lung Cancer	Phase 1
Withdrawn	`NCT03004105` - MEDI4736 With Selumetinib for KRAS Mutant Non-Small Cell Lung Cancer (NSCLC)	Phase 2
Withdrawn	`NCT03501056` - Study of Activated Cytokine-induced Killer Armed With Bispecific Antibody for Advanced Lung Cancer	Phase 2
Not yet recruiting	`NCT05279521` - The Effect of Interventional Pulmonary Rehabilitation Exercise With Advanced Lung Cancer.	N/A
Terminated	`NCT02768337` - Cambridge Brain Mets Trial 1	Phase 1/Phase 2
Completed	`NCT04672369` - A Study to Evaluate the Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced NSCLC	Phase 1
Recruiting	`NCT03751592` - Phase Ib/IIa Studies of Chlorogenic Acid for Injection for Safety and Efficacy of Advanced Lung Cancer	Phase 1/Phase 2
Not yet recruiting	`NCT05431569` - A Phase IIa Study to Evaluate the Efficacy and Safety of 6MW3211 in Patients With Advanced Lung Cancer	Phase 2
Recruiting	`NCT06228209` - Tier - Palliative Care For Patients With Advanced Heart Failure or Cancer	N/A
Completed	`NCT04672356` - A Study to Evaluate the Safety , Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer	Phase 1
Active, not recruiting	`NCT04670445` - Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Advanced Cancer	N/A
Not yet recruiting	`NCT06107894` - TIL Therapy for Patients With Advanced Solid Tumors	Phase 1
Recruiting	`NCT06183762` - A Real-World Study of Treatment Patterns and Effectiveness in MET Mutation-Positive Advanced Lung Cancer
Recruiting	`NCT05664971` - JS004 Combined With Toripalimab and With Standard Chemotherapy Treat Patients With Advanced Lung Cancer	Phase 1/Phase 2
Recruiting	`NCT05815862` - Clinical Study of AL2846 Capsules in the Treatment of Advanced Lung Tumor and Advanced Ovarian Cancer	Phase 2
Recruiting	`NCT05805956` - IMM2902 in Patients With Advanced Solid Tumors Expressing HER2	Phase 1/Phase 2
Recruiting	`NCT06106152` - WTX212A Monotherapy and in Combination With PD -1/PD-L1 Monoclonal Antibody	Early Phase 1
Recruiting	`NCT05000684` - Study of JS004 Combined With Toripalimab for Advanced Lung Cancer	Phase 1/Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.