NCT05266846 Pembrolizumab Plus Bevacizumab and Chemotherapy for ALK-rearranged NSCLC With Persistent 5'ALK
| NCT ID | NCT05266846 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Hunan Province Tumor Hospital |
| Condition | ALK Gene Mutation |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2024-05-29 |
| Primary Completion | 2026-11-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 78 participants in total. It began in 2024-05-29 with a primary completion date of 2026-11-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is an open-label, multiple centers, two-arms phase II study to evaluate the safety and efficacy Pembrolizumab,Bevacizumab in combination with Chemotherapy could improve PFS in Alectinib Failed ALK-rearranged Advanced Lung Adenocarcinoma with Persistent 5'ALK. The eligible patients should have Stage IV Adenocarcinoma ALK-rearranged tested by NGS Perisitent with 5'ALK Failed from first line Alectinib. The patients should meet the physical requirements to receive Pembrolizumab, Bevacizumab with Chemotherapy. All the patients who meet these requirements will be enrolled in this study. The eligible patients will be treated with Pembrolizumab 200 mg intravenously (IV) plus Bevacizumab 15mg/kg+ Pemetrexed 500mg/m2+Carboplatin AUC=4 for up to 4 cycles followed by Pembrolizumab 200mg Q3W+ Bevacizumab 15mg/kg+Pemetrexed 500mg/m2 for up to 31cycles or until disease progression, intolerable toxicity, or physician or participant decision.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years of age on day of signing informed consent. * Stage IV ALK-rearranged Lung Adenocarcinoma Persistent with 5'ALK Failed from first line Alectinib * Have at least 1 lesion that meets the criteria for being measurable, as defined by RECIST 1.1, and is appropriate for selection as a target lesion, as determined by local site investigator radiology review. Lesions that appear measurable, but have undergone palliative irradiation, cannot be target lesions ④20 FFPE sliders prepared,Subjects who do not have histology samples (defined as core or excisional biopsy, or resections) will need to undergo a new biopsy to provide a tissue sample ⑤Eastern Cooperative Oncology Group performance status 0 or 1 * Life expectancy ≥3 months * Adequate hematologic and end organ function Exclusion Criteria: Cancer-Specific Exclusions: ①Active or untreated central nervous system metastases ②Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome General Medical Exclusions: * Pregnant or lactating women. * Has active autoimmune disease that has required systemic treatment in the past 2 years. * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted. * Positive test for human immunodeficiency virus. ⑤Active hepatitis B or hepatitis C. ⑥Severe infection within 4 weeks prior to randomization . ⑦Significant cardiovascular disease. ⑧Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures. ⑨Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment for another health-related problem. Exclusion Criteria Related to Medications: Prior treatment with anti-programmed death-1, anti-PD-L1 therapeutic antibodies，and anti-VEGF agents.
Contact & Investigator
Yongchang C Zhang, MD
PRINCIPAL INVESTIGATOR
Hunan Cancer Hospital
Frequently Asked Questions
Who can join the NCT05266846 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ALK Gene Mutation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05266846 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05266846 currently recruiting?
Yes, NCT05266846 is actively recruiting participants. Contact the research team at zhangyongchang@csu.edu.cn for enrollment information.
Where is the NCT05266846 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT05266846 clinical trial?
NCT05266846 is sponsored by Hunan Province Tumor Hospital. The principal investigator is Yongchang C Zhang, MD at Hunan Cancer Hospital. The trial plans to enroll 78 participants.