Trametinib Plus Anlotinib Combined With Tislelizumab in KRAS-mutant NSCLC
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Chest Hospital
About this trial
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.
Eligibility criteria
Qualifiers
According to the 8th edition of the AJCC/UICC TNM staging system for NSCLC, patients with locally advanced (stage III B/III C), metastatic or recurrent (stage IV) NSCLC confirmed by histology or cytology who are unable to undergo surgery and radical concomitant radiochemotherapy and are confirmed to have at least one measurable lesion according to RECIST 1.1.
KRAS mutation positive detected by ARMS or NGS;
Have been treated with 1st line of standard therapy and experienced disease progression;
Patients who were assessed as CR, PR, or SD (reduction) after being treated with 2 cycles of anlotinib and trametinib.
Disqualifiers
Small cell lung cancer (including mixed small cell and non-small cell lung cancer);
Patients who have received previous treatment ≥ 4th lines of standard therapies.;
There are obvious bleeding symptoms or active autoimmune disease;
Patients with other driver mutation.
Trial design
Treatments tested in this trial
- Trametinib
- Anlotinib
- Tislelizumab
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Shanghai Chest Hospital
Lead sponsor
BeiGene
Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Collaborator
Novartis
Collaborator
Source ClinicalTrials.gov