Cranial Radiotherapy Plus Chemoimmunotherapy in Untreated Driver-mutation Negative NSCLC With Stable Brain Metastasis

Sponsor
Fudan University
Study ID
NCT06501391
Phase
PHASE2
Status
Recruiting
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Conditions

  • Brain Metastases
  • NSCLC Stage IV

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PD-L1/PD-1 inhibitor and chemotherapy — DRUG
    Stable brain metastases patients in this arm will receive PD-L1/PD-1 inhibitors and chemotherapy.
  • SRT or WBRT — RADIATION
    Stable brain metastases (BM) patients in this arm will receive stereotactic radiotherapy (SRT) and whole brain radiation therapy (WBRT) according to their BM condition.

Study Details

Non-small cell lung cancer (NSCLC), the most prevalent form of lung cancer, has a significant risk of brain metastasis (BM). Historically, the median overall survival for advanced NSCLC patients with BM was under six months with traditional chemotherapy. However, recent advancements with immune checkpoint inhibitors (ICIs) have shown promise, with some studies reporting improved intracranial objective response rates, progression-free survival, and overall survival when combined with chemotherapy. Despite these improvements, challenges remain, such as treatment resistance, recurrence, and the need for better therapeutic strategies. Local interventions like stereotactic radiotherapy (SRT) and whole brain radiation therapy (WBRT) have been crucial for treating BM, with SRT being particularly effective. The combination of immunotherapy and radiotherapy is emerging as a synergistic approach, with studies suggesting it may enhance local control and survival rates while maintaining safety. Guidelines recommend SRT for patients with limited BMs, and clinical data support the safety and efficacy of combining brain radiotherapy with immunotherapy. A meta-analysis and other studies have shown promising results with this combination, including local control rates and overall survival benefits, with manageable toxicities. However, there is still a need for more prospective clinical trials to verify the safety and efficacy of combining cranial radiotherapy with immunotherapy in NSCLC patients with BM, especially those without driver gene mutations. Therefore, we plan to conduct a phase 2 prospective study, focusing on combining brain radiotherapy with PD-1/PD-L1 inhibitors. We will stratify eligible patients based on the status of BMs (active BM vs stable BM) .

Key Dates

First listed
Jul 15, 2024
Start date
Jul 1, 2024
Status verified
Aug 2024
Primary completion
Jul 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
54 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: stable BM, PD-1/PD-L1 inhibitors plus chemotherapy
  • Experimental: stable BM, PD-1/PD-L1 inhibitors, chemotherapy plus radiotherapy

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 2 years ]

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