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Efficacy and Safety of Platinum-based Chemotherapy + Bevacizumab + Durvalumab, and Salvage SBRT for IV Non-Small Cell Lung Cancer Patients With EGFR Mutations After Failure of First Line Osimertinib: A Multicenter, Prospective, Phase II Clinical Study

NCT04517526 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-08-18

No results posted yet for this study

Summary

Lung cancer still occupies the highest incidence and mortality rate in the wordwild, and non-small cell lung cancer (NSCLC) accounts for about 80% to 85% of all lung cancers. Currently, immune checkpoint inhibitors targeting PD-1/PD-L1 have become one of the new standard treatments for advanced NSCLC in some molecular subtypes. In the Asian population, EGFR mutations are the most important molecular subtype in lung cancer patients, with an incidence of 39.6% in NSCLC and even more than 50% in adenocarcinoma. EGFR-TKIs are still the first-line treatment for advanced EGFR-mutant NSCLC and can induce a rapid response in this type of NSCLC, but acquired resistance usually occurs between 9 and 16-18 months (three generations of TKI), and the mechanism is complex. Subsequent treatment options are challenging. In contrast, immune checkpoint inhibitors have a specific role in improving the immune status of cancer patients, which may lead to sustained disease control. Clinical studies have shown that the regimen of pemetrexed/platinum-based chemotherapy combined with/PD-L1 inhibitors and bevacizumab has been effective in patients with EGFR-sensitive mutations. Preclinical and clinical studies have shown that EGFR-TKIs can modulate the tumor immune microenvironment and optimize the anti-tumor activity, thus enhancing the benefit of PD-1/PD-L1 inhibitors in patients with NSCLC. In addition, recent studies have shown that stereotactic body radiotherapy (SBRT/SRT) also performs well in the treatment of patients with stage IV NSCLC and can bring survival benefits to patients with advanced disease. We propose to design a prospective, multicenter, phase II clinical study of platinum-containing dual-drug chemotherapy + bevacizumab + SBRT/SRT for EGFR-mutant non-small cell lung cancer with first-line progression of Osimertinib, taking into account the current clinical research status. The Durvalumab regimen consists of 4 to 6 cycles of bevacizumab and/or Durvalumab maintenance therapy until disease progression, with stereotactic radiotherapy to oligoprogression sites, with the ultimate expectation of long-term survival benefit for this group of patients. The primary endpoints are PFS, overall OS, secondary endpoints are treatment-related toxicity, disease control rate, and exploratory endpoints are molecular markers of potential efficacy and toxicity,

Conditions

  • Lung Cancer Stage IV，EGFR-mutant，TKI，PD-L1，SBRT

Interventions

DRUG

pemetrexed，cisplatin/carboplatin，bevacizumab，durvalumab，SBRT

pemetrexed (500 mg/m2/d1) + cisplatin/carboplatin (20-25 mg/m2 × 3 days/AUC 5) + bevacizumab (7.5 mg/kg) + durvalumab (10 mg/kg) every 3 weeks for 4 to 6 cycles after informed consent, followed by bevacizumab and/or durvalumab anti-maintenance therapy until the emergence of what the investigator considers to be treatment-related toxicity or disease progression in the patient, followed by stereotactic radiotherapy to appropriate oligometastatic or oligoprogressive sites.

Sponsors & Collaborators

  • Shanghai Cancer Hospital, China

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2022-11-01
Completion
2022-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04517526 on ClinicalTrials.gov