Health TrialsbyHealthPanel

Trametinib Plus Anlotinib Combined With Tislelizumab in KRAS-mutant NSCLC

ConditionsKRAS Mutation-Related TumorsAdvanced Lung CancerRefractory Tumor
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Trametinib

    Drug

    Trametinib will be administrated orally every day.

  • Anlotinib

    Drug

    Anlotinib will be administrated orally from day 1 to day 14 per 21-day cycle.

  • Tislelizumab

    Drug

    Tislelizumab will be administered at full dose (200mg, Q3W) on the patient who received the efficacy evaluation of stable disease (SD) or partial response (PR) or complete response (CR) after 2 cycles' treatment of trametinib plus anlotinib.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Trametinib + Anlotinib + TislelizumabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

RP2D

recommended phase 2 dose

Time frame
up to 12 months
2

PFS

progression-free survival

Time frame
up to 18 months

Secondary outcomes

1

ORR

objective response rate

Time frame
up to 12 months
2

OS

overall survival

Time frame
up to 24 months
3

DOR

duration of response

Time frame
up to 18 months
4

AEs

adverse events

Time frame
up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Chest Hospital

Lead sponsor

BeiGene

Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Collaborator

Novartis

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: