Trametinib Plus Anlotinib in Non-G12C KRAS-Mutant NSCLC Patients

Status Completed

Clinical Trial Summary

This is a Phase I exploratory study. The study is divided into two parts (A/B).In part A, the primary endpoint is the determination of the recommended phase 2 dose (RP2D). Secondary endpoint for phase Ia includes evaluating the objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and adverse events (AEs). Following the establishment of the RP2D, the expansion cohort will be initiated. Transitioning to part B, 20 patients will be enrolled to further evaluate the ORR. All patients will receive the trametinib plus anlotinib regimen based on the RP2D determined in part A. The primary endpoint for part B is to assess the ORR, while secondary endpoint includes evaluating PFS, overall survival (OS), DCR, AEs, and duration of overall response (DoR). In part A, the study plans to enroll eligible patients to receive the MEK inhibitor trametinib (2 mg) in combination with anlotinib (6mg, 8 mg, 10 mg, 12 mg). The number of subjects is determined according to the actual situation of dose climbing. In part B, another 20 eligible patients will be enrolled and treated with trametinib (2mg) + anlotinib (RP2D), until the disease progression (PD) or unacceptable toxicity occurs to further evaluate the safety, tolerability and efficacy. Patients participated in safety follow-up after the first course of treatment until 3 months after discontinuation due to PD or toxicity. Dose-limiting toxicities from the first cycle were collected. Therapeutic efficacy evaluation was scheduled according to RECIST version 1.1 every 4-8 weeks. After the investigators' evaluation, the assessment cycle could extend to 12 weeks or longer due to the uncontrollable factors during the treatment period. Blood samples will be collected for pharmacokinetic analysis and biomarker discovery at baseline and at each periodic assessment.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04967079
Study type	Interventional
Source	Shanghai Chest Hospital
Contact
Status	Completed
Phase	Phase 1
Start date	August 1, 2021
Completion date	March 26, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05094804` - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents	Phase 1/Phase 2
Recruiting	`NCT05707286` - Pilot Study to Determine Pro-Inflammatory Cytokine Kinetics During Immune Checkpoint Inhibitor Therapy
Recruiting	`NCT04258137` - Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study	N/A
Completed	`NCT01945021` - Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC	Phase 2
Completed	`NCT04487457` - Prospective Study to Evaluate the Blood Kinetics of Immune Cells and Immunosuppressive Cytokines After Exposure to an Immunity Checkpoint Inhibitor (ICI): Study of the Impact of Chemotherapy
Terminated	`NCT04022876` - A Study of ALRN-6924 for the Prevention of Chemotherapy-induced Side Effects (Chemoprotection)	Phase 1
Recruiting	`NCT05898763` - TEIPP Immunotherapy in Patients With NSCLC	Phase 1/Phase 2
Recruiting	`NCT05532696` - Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients	Phase 1/Phase 2
Completed	`NCT04311034` - A Study of RC48-ADC in Subjects With Advanced Non-small Cell Lung Cancer	Phase 1/Phase 2
Active, not recruiting	`NCT03177291` - Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC	Phase 1
Terminated	`NCT03257722` - Pembrolizumab + Idelalisib for Lung Cancer Study	Phase 1/Phase 2
Completed	`NCT00349089` - Trial on Refinement of Early Stage Lung Cancer Adjuvant Therapy	Phase 2
Completed	`NCT05116891` - A Phase 1/2 Study of CAN04 in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumors	Phase 1/Phase 2
Recruiting	`NCT04571632` - Clinical Trial of SBRT and Systemic Pembrolizumab With or Without Avelumab/Ipilimumab+ Dendritic Cells in Solid Tumors	Phase 2
Terminated	`NCT03599518` - DS-1205c With Gefitinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer	Phase 1
Not yet recruiting	`NCT06020989` - Lazertinib and Chemotherapy Combination in EGFR-mutant NSCLC Patients Without ctDNA Clearance After lead-in Lazertinib Monotherapy	Phase 2
Withdrawn	`NCT03982134` - PDR001 + Panobinostat for Melanoma and NSCLC	Phase 1
Withdrawn	`NCT03574649` - QUILT-2.024: Phase 2 Neoadjuvant, Consolidation, and Adjuvant Combination NANT Immunotherapy Versus Standard of Care in Subjects With Resectable Non-small Cell Lung Cancer	Phase 2
Withdrawn	`NCT02844140` - DE-CT in Lung Cancer Proton Therapy	N/A
Terminated	`NCT02628535` - Safety Study of MGD009 in B7-H3-expressing Tumors	Phase 1