Combining Serplulimab, Bevacizumab, and chemotherapy for lung cancer after TKI failure

A Multi-center, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of Serplulimab Plus Bevacizumab and Chemotherapy for EGFRm+ Locally Advanced or Metastasis Non-Squamous NSCLC Patients After EGFR-TKI Treatment Failure

This study is testing a new combination of Serplulimab, Bevacizumab, and chemotherapy to see if it helps adults with advanced lung cancer who didn't respond to earlier treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Henan Cancer Hospital (Government)
• Drugs / interventions: Serplulimab, Bevacizumab, chemotherapy
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT06334757 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of a combination treatment involving Serplulimab, Bevacizumab, and chemotherapy in patients with EGFR-mutant non-squamous non-small cell lung cancer (NSCLC) who have not responded to previous EGFR-TKI therapy. The trial focuses on adult patients aged 18 to 70 years with advanced stages of NSCLC that are not suitable for surgery or radical treatment. Participants will receive the combination therapy to assess its impact on tumor response and overall health outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with EGFR-mutant metastatic non-squamous NSCLC who have experienced treatment failure with EGFR-TKI.

Not a fit: Patients with untreated symptomatic brain metastases or those who have previously received certain immunotherapies or VEGF inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with resistant EGFR-mutant NSCLC.

How similar studies have performed: While this approach is relatively novel, previous studies have shown promise in combining immunotherapy with chemotherapy for lung cancer treatment.

Eligibility criteria

Inclusion Criteria:

1. Signed written informed consent before any trial-related processes;
2. Age ≥ 18 years and ≤70 years male or females;
3. Has a histologically or cytologically confirmed stage IIIB/IIIC (American Joint Committee on Cancer \[AJCC\] 8th edition) NSCLC that is unresectable and not fit for radical concurrent chemoradiotherapy, or metastatic / recurrent non-squamous NSCLC;
4. Patients with EGFR mutation confirmed by tumor histology or cytology or hematology prior to EGFR-TKI treatment
5. EGFR-TKI resistance, confirmed by RECIST 1.1
6. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;

Exclusion Criteria:

1. History of severe allergies to any study drug
2. Has previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or any other stimulatory or inhibitory agents of T cell receptors
3. Previous exposure to VEGF inhibitor for anti-cancer treatment
4. Patients with untreated symptomatic brain metastases. Patients with treated brain metastases will be allowed if brain imaging obtained greater than 4 weeks from trial enrollment reveals stable disease.
5. Has received a live-virus vaccination within 28 days of planned treatment start
6. Interstitial lung disease or pneumonitis requiring oral or IV glucocorticoids Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study

Where this trial is running

Zhengzhou, Henan

• Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)

Study contacts

• Study coordinator: zhen he

Conditions Non-Squamous Non-Small Cell Lung Cancer