Clinical trial · Interventional
Serplulimab Plus Bevacizumab and Chemotherapy for EGFR-mutant Metastatic NSCLC Patients After EGFR-TKI Treatment 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
NCT06334757CI-TRIAL-00075502unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy and safety of Serplulimab Plus Bevacizumab and chemotherapy in TKI-resistant EGFR-mutated non-squamous NSCLC Chinese patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Squamous Non-Small Cell Lung Cancer | Lung Non-Squamous Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab Biosimilar HLX04 | Drug | Bevacizumab | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
| Serplulimab | Drug | Serplulimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Serplulimab+Bevacizumab+Pemetrexed+Carboplatin
- description
- Using Serplulimab in combination with bevacizumab, carboplatin and pemetrexed to treat patients with EGFR mutated, advanced non-small cell lung cancer (NSCLC) after failure of EGFR tyrosine kinase inhibitors.
- interventionNames
- Drug: Serplulimab
- Drug: Bevacizumab Biosimilar HLX04
- Drug: Pemetrexed
- Drug: Carboplatin
Primary outcomes (1)
- measure
- ORR(Overall Response Rate)
- timeFrame
- From start of treatment to 12 months
- description
- The proportion of subjects who have a complete response (CR) or a partial response (PR)
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.