Efficacy and Biomarker Explanation of IBI-323 + Bevacizumab Plus Platinum Based Chemotherapy on ALK-Rearranged NSCLC

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05296278
• Other study ID #: REVERSE
• Status: Recruiting
• Phase: Phase 2
• Start date: December 25, 2023
• Est. completion date: April 1, 2026

Study information

• Verified date: January 2024
• Source: Hunan Province Tumor Hospital
• Contact: Yongchang C Zhang, MD
• Phone: +8613873123436
• Email: zhangyongchang[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 1, 2026
• Est. primary completion date: December 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• IBI-323 combined with bevacizumab plus Platinum
IBI-323 (30 mg/kg) ccombined with bevacizumab (15 mg/kg) plus platinum based chemotherapy ivgtt, every 21 days until disease progression

Locations

Country	Name	City	State
China	Hunan Cancer hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Province Tumor Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects	1 year
Secondary	OS	Defined as the time from the start of treatment to the death of the subject due to any cause.	1 year
Secondary	DCR	Disease control rates were assessed according to RECIST V1.1	1 year