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

ConditionsALK Gene MutationLung AdenocarcinomaImmunotherapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHunan Province Tumor Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pembrolizumab injection

    Drug

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

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: Pembrolizumab plus Bevacizumab and ChemotherapyExperimental treatment 1 intervention
Group B: Bevacizumab plus ChemotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

PFS

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

Time frame
2 years

Secondary outcomes

1

ORR

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

Time frame
2 years
2

DCR

Defined as the proportion of subjects with complete remission (CR), partial remission (PR) and stable disease (SD) to the total subjects

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hunan Province Tumor Hospital

Lead sponsor

Source ClinicalTrials.gov
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