Efficacy and Safety of HGXJT in Bone Metastatic NSCLC Patients (NCT05378334) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy and Safety of HGXJT in Bone Metastatic NSCLC Patients
China82 participantsStarted 2022-06-15
Plain-language summary
This is a double-blind, randomized controlled study evaluating the efficacy and safety of HGXJT in combination with ICI-based standard treatment in lung cancer patients with bone metastases. Enrolled participates will randomly receive HGXJT or placebo during the first 4-6 cycles of ICI-based standard treatment.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Patients with non-small cell lung cancer diagnosed by histopathology or cytopathology.
✓. Presence of bone metastases.
✓. EGFR/ALK gene wild type.
✓. No prior treatment with PD-1 inhibitors (combination or monotherapy)
✓. Those who have not received prior antitumor therapy or have not received further antitumor therapy after failure of first-line antitumor therapy.
✓. PS score (ECOG) ≤ 2 points
✓. Normal hepatic and renal function.
✓. Presence of at least one assessable lesion.
Exclusion criteria
✕. Unable to complete the baseline assessment form
✕. Combination of other serious illnesses, including uncontrolled active infection, severe electrolyte disturbances, and significant bleeding tendencies.
✕. Pregnant or lactating women.
✕. Combined autoimmune diseases, hematologic disorders, or long-term use of hormones or immunosuppressive drugs.
✕. Combination of other uncontrolled tumors.
✕. Combination of severe brain or mental illness that affects the patient's ability to self-report.
What they're measuring
1
(Disease control rate assessed by investigators) DCR (CR+PR+SD)
Timeframe: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.
Trial details
NCT IDNCT05378334
SponsorGuangzhou University of Traditional Chinese Medicine