Bevacizumab Plus Nab-paclitaxel and Platinum for Immunotherapy-treated Non-squamous Non-small Cel… (NCT05407155) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Bevacizumab Plus Nab-paclitaxel and Platinum for Immunotherapy-treated Non-squamous Non-small Cell Lung Cancer
China56 participantsStarted 2022-06-09
Plain-language summary
Immune checkpoint inhibitor (ICI)-based regimen has been widely used in first-line treatment of driver-gene-negative non-squamous non-small cell lung cancer. This study investigate the efficacy and safety of the combination of bevacizumab plus nab-paclitaxel and platinum as second-line treatment for driver-gene-negative non-squamous non-small cell lung cancer patients progressed after ICI-based treatments.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. The participants voluntarily signed the informed consent form.
✓. The participants should be 18\~75 years old.
✓. Histology or cytology confirmed, stage IIIB to IV non-small cell lung cancer (according to the eighth edition of the American Joint Committee on cancer AJCC staging) that could not undergo radical treatment.
✓. No sensitive EGFR mutation, ALK gene rearrangement and ROS1 gene rearrangement are allowed.
✓. Progressed after first-line treatment included immune checkpoint inhibitor (including CTLA-4 monoclonal antibody, PD-1/L1 monoclonal antibody monothrapy or combination therapy, with or without chemotherapy. If the first-line treatment is discontinued due to adverse effects, and patients received no other treatment before disease progression.
✓. For patients who have previously received neoadjuvant and/or adjuvant immune checkpoint inhibitor treatment (with or without chemotherapy or radiotherapy) for the purpose of radical treatment of non-metastatic disease, if first-line treatment contained immune checkpoint inhibitors (the same or different immune checkpoint inhibitors with neoadjuvant or adjuvant settings), they can also be included.
✓. At least one measurable lesion according to RECIST criteria v1.1. If patients received radiotherapy, they can be included only when disease progression of the previously irradiated lesion is observed, and the previously irradiated lesion is not the only lesions.
✓. ECOG PS score: 0-1.
Exclusion criteria
✕. Histologically mixed with small cell or squamous lung cancer.
What they're measuring
1
Objective response rate
Timeframe: From enrollment to end of study, up to 2 years
✕. Previously received anti-angiogenic drugs (including bevacizumab, arotinib, apatinib, etc.) and/or paclitaxel (including paclitaxel, paclitaxel liposomes, and nab-paclitaxel). If paclitaxel is used in the adjuvant treatment setting, patients who progressed after 6 months from the last dose of paclitaxel can be included.
✕. Patients diagnosed with secondary primary malignant tumor within 5 years before enrollment, except cured cervical carcinoma in situ, superficial bladder tumor \[Ta, Tis and T1\], basal or squamous cell skin cancer, localized prostate cancer after radical surgery and breast ductal carcinoma in situ after radical surgery.
✕. Patients with leptomeningeal metastasis or untreated symptomatic or rapidly progressing CNS metastasis.
✕. Unrelieved toxic reactions of CTCAE (5.0) grade 2 or higher caused by any previous treatments, excluding hair loss, nausea and vomiting.
✕. For uncontrollable tumor-related pain, patients who need analgesic treatment must have a stable analgesic treatment plan at enrollment. If there are symptomatic lesions suitable for palliative radiotherapy (such as bone metastasis or metastatic nerve invasion), the treatment should be completed before enrollment. The patient should recover from the effects of radiation. For asymptomatic metastatic lesions, if the investigator believes there is the possibility of dysfunction or intractable pain (such as epidural metastasis not currently related to spinal cord compression), local regional treatment should be considered before enrollment.
✕. Major surgery other than that for the purpose of diagnosis was performed within 4 weeks before enrollment, or expected major surgery during the study period.
✕. Serious infection within 4 weeks before enrollment, including but not limited to infection, bacteremia or severe pneumonia that leads to hospitalization, or any active infection that the investigator believes may affect the safety of patients.