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

NCT05266846 | Recruiting Phase 2

• 1 other identifier: 2022017
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

ALK Gene Mutation; Lung Adenocarcinoma; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• PFS

  Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)

  2 years

Secondary Outcomes (2)

• ORR

  2 years

• DCR

  2 years

Study Arms (2)

Pembrolizumab plus Bevacizumab and Chemotherapy

EXPERIMENTAL

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

Drug: Pembrolizumab injection

Bevacizumab plus Chemotherapy

EXPERIMENTAL

Bevacizumab plus Chemotherapy was used for ALK-rearranged NSCLC With Persistent 5'ALK.

Drug: Pembrolizumab injection

Interventions

Pembrolizumab injection DRUG

Pembrolizumab 20mg ivgtt once every 21day Platium based Chemotherapy ivgtt once every 21day Bevacizumab 15mg/kg ivgtt once every 21day

Also known as: pemetrexed, Bevacizumab, CISPLATIN

Bevacizumab plus Chemotherapy; Pembrolizumab plus Bevacizumab and Chemotherapy

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Hunan Province Tumor Hospital: lead

Study Sites (1)

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

pembrolizumab; Pemetrexed; Bevacizumab; Cisplatin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Yongchang C Zhang, MD

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Deputy Director of Thoracic Oncology Department

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 4, 2022
• Study Start: May 29, 2024
• Primary Completion (Estimated): November 16, 2026
• Study Completion (Estimated): February 16, 2027
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

CN (1)