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

NCT05296278 | Recruiting Phase 2

• 1 other identifier: REVERSE
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• ORR

  Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects

  1 year

Secondary Outcomes (2)

• OS

  1 year

• DCR

  1 year

Study Arms (2)

Cohort A

EXPERIMENTAL

patients with only 3'ALK confirmed by NGS

Drug: IBI-323 combined with bevacizumab plus Platinum

Cohort B

EXPERIMENTAL

patients with 3'ALK with retention of 5'ALK

Drug: IBI-323 combined with bevacizumab plus Platinum

Interventions

IBI-323 combined with bevacizumab plus Platinum DRUG

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

Cohort A; Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hunan Province Tumor Hospital: lead

Study Sites (1)

Hunan Cancer hospital

Changsha, Hunan, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Bevacizumab; Platinum

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Central Study Contacts

Yongchang C Zhang, MD

CONTACT

+8613873123436; zhangyongchang@csu.edu.cn

Nong C Yang, MD

CONTACT

+8613873123436; yangnong0217@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Medical Oncology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: March 25, 2022
• Study Start: December 25, 2023
• Primary Completion: December 10, 2025
• Study Completion: April 1, 2026
• Last Updated: January 10, 2024

Record last verified: 2024-01

Locations

CN (1)