Pembrolizumab Plus Bevacizumab and Chemotherapy for ALK-rearranged NSCLC With Persistent 5'ALK

Immunotherapy Clinical Trial

Official title:

Pembrolizumab Plus Bevacizumab and Chemotherapy in Alectinib Failed ALK-rearranged Advanced Lung Adenocarcinoma Patients With Persistent 5'ALK: An Open Label, Single Arm, Phase II Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05266846
• Other study ID #: PROMOTION
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 20, 2024
• Est. completion date: February 16, 2025

Study information

• Verified date: December 2023
• 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 is an open-label, multiple center, single-arm 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: February 16, 2025
• Est. primary completion date: November 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ?20 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 ?Eastern Cooperative Oncology Group performance status 0 or 1
• Life expectancy =3 months
• Adequate hematologic and end organ function Exclusion Criteria: Cancer-Specific Exclusions: ?Active or untreated central nervous system metastases ?Malignancies 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. ?Active hepatitis B or hepatitis C. ?Severe infection within 4 weeks prior to randomization . ?Significant cardiovascular disease. ?Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures. ?Is 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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung
• ALK Gene Mutation
• Immunotherapy
• Lung Adenocarcinoma

Intervention

Drug:
• Pembrolizumab Combined With Bevacizumab and Chemotherapy
Pembrolizumab + Bevacizumab + Chemotherapy

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	PFS	Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)	2 years
Secondary	ORR	Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects	2 years
Secondary	DCR	Defined as the proportion of subjects with complete remission (CR), partial remission (PR) and stable disease (SD) to the total subjects	2 years