Trametinib Plus Anlotinib Combined With Tislelizumab in KRAS-mutant NSCLC

Sponsor
Shanghai Chest Hospital
Study ID
NCT06456138
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced Lung Cancer
  • KRAS Mutation-Related Tumors
  • Refractory Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jul 1, 2024
Status verified
Jun 2024
Primary completion
Jun 30, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Trametinib + Anlotinib + Tislelizumab
    In Phase I, there are four treatment arms: anlotinib (6 mg) plus trametinib (1 mg) plus tislelizumab (200 mg, Q3W), anlotinib (6 mg) plus trametinib (2 mg) plus tislelizumab (200 mg, Q3W), anlotinib (8 mg) plus trametinib (1 mg) plus tislelizumab (200 mg, Q3W), and anlotinib (8 mg) plus trametinib (2 mg) plus tislelizumab (200 mg, Q3W). In Phase II, there is one treatment arm including trametinib (RP2D) plus anlotinib (RP2D) plus tislelizumab (200 mg, Q3W).

Primary Outcome Measure

RP2D [ Time Frame: up to 12 months ]

Central Contacts

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