Combining IBI-323 with Bevacizumab and Chemotherapy for Lung Cancer Treatment
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
This study is testing a new treatment combining IBI-323, bevacizumab, and chemotherapy for adults with a specific type of lung cancer who haven't improved with their previous medication.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hunan Province Tumor Hospital Academic / other |
| Drugs / interventions | bevacizumab, Alectinib, chemotherapy, radiation |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT05296278 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of IBI-323 in combination with bevacizumab and platinum-based chemotherapy for patients with ALK-rearranged non-small cell lung cancer (NSCLC) who have not responded to first-line treatment with Alectinib. The trial aims to evaluate both the efficacy of this combination therapy and the potential biomarkers that may explain its effects. Participants must be adults aged 18 to 75 with a confirmed diagnosis of lung adenocarcinoma and stable brain metastases. The study will assess measurable lesions using imaging techniques according to established criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with ALK-rearranged lung adenocarcinoma who have experienced treatment failure with Alectinib.
Not a fit: Patients who are pregnant, breastfeeding, or have contraindications to chemotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could provide a new effective option for patients with ALK-rearranged NSCLC who have failed previous therapies.
How similar studies have performed: While this specific combination has not been widely tested, similar approaches in targeting ALK-rearranged NSCLC have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Changsha, Hunan
- Hunan Cancer hospital — Changsha, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Yongchang C Zhang, MD
- Email: zhangyongchang@csu.edu.cn
- Phone: +8613873123436
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.