NCT05296278RecruitingPhase 2
Efficacy and Biomarker Explanation of IBI-323 Combined With Bevacizumab Plus Platinum Based Chemotherapy on ALK-Rearranged Non-Small Cell Lung Cancer Who Failed From First Line Alectinib
Hunan Province Tumor Hospital1 site in 1 country70 target enrollmentStarted: December 25, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- ORR
Study Overview
Brief Summary
This study aimed to explore the efficacy and biomarker explanation of IBI-323 combined with bevacizumab plus platinum based chemotherapy on ALK-rearranged non-small cell lung cancer who failed from first line Alectinib.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Sign written informed consent before implementing any trial-related procedures;
- •Age ≥18 years old and ≤75 years old.
- •No limit on the gender.
- •Patients diagnosed with Lung Adenocarcinoma ALK-Rearranged Stage IIIA-IV by pathology.
- •Patients who failed from first line Alectinib with stable brain metastasis included (Radiotherapy treated Oligo-metastasis).
- •According to the Solid Tumor Efficacy Evaluation Criteria (RECIST V1.1), at least one lesion can be measured on imaging. Lesions located in the field of previous radiation therapy may be considered measurable if progression is demonstrated.
- •ECOG score 0-1 points.
Exclusion Criteria
- •Patients with contraindication of chemotherapy Pregnant or breast feeding women.
- •Participate in another interventional clinical study, unless participating in an observational (non-interventional) clinical study or in the survival follow-up phase of an interventional study.
- •Participants are known to have had previous severe allergic reactions to other monoclonal antibodies or to any of the components of the IBI323 preparation, and severe allergies to bevacizumab, pemetrexed, cisplatin, and carboplatin.
- •Previous systematic anti-tumor therapy for advanced non-squamous NSCLC other than ALK-TKI (including cytotoxic chemotherapy in combination with radiotherapy).
- •Previous use of anti-PD-1 anti-PD-L1 anti-programmed death receptor ligand 2(PD-L2) or anti-cytotoxic T-lymphocyte-associated antigen 4(CTLA-4) drugs or any other drugs that act on T-cell co-stimulation or checkpoint pathways (such as OX40 CD137 LAG3, etc.).
- •Radical radiation therapy within 28 days prior to the first dose, or palliative radiation therapy within 14 days prior to the first dose.
- •Received ALK-TKI treatment within 2 weeks prior to the first administration of the study drug
Arms & Interventions
Cohort A
Experimental
patients with only 3'ALK confirmed by NGS
Intervention: IBI-323 combined with bevacizumab plus Platinum (Drug)
Cohort B
Experimental
patients with 3'ALK with retention of 5'ALK
Intervention: IBI-323 combined with bevacizumab plus Platinum (Drug)
Outcomes
Primary Outcomes
ORR
Time Frame: 1 year
Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects
Secondary Outcomes
- OS(1 year)
- DCR(1 year)
Investigators
Yongchang Zhang
Director, Head of Medical Oncology, Principal Investigator, Clinical Professor
Hunan Province Tumor Hospital
Study Sites (1)
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