Objective This study aimed to observe and compare the efficacy and safety of different anticoagulants combined with immunotherapy and chemotherapy for advanced nonsmall cell lung cancer (NSCLC). Methods In this prospective, randomized, controlled clinical trial, treatment-naïve subjects with stage <InlineEquation ID="IEq300"> <EquationSource Format="TEX">$\text{I}\!\text{I}\!\text{I}$</EquationSource> <EquationSource Format="MATHML"><math> <mrow> <mtext>I</mtext> <mspace width="-0.166667em" /> <mtext>I</mtext> <mspace width="-0.166667em" /> <mtext>I</mtext> </mrow> </math></EquationSource> </InlineEquation>B–<InlineEquation ID="IEq301"> <EquationSource Format="TEX">$\text{I}\!\text{V}$</EquationSource> <EquationSource Format="MATHML"><math> <mrow> <mtext>I</mtext> <mspace width="-0.166667em" /> <mtext>V</mtext> </mrow> </math></EquationSource> </InlineEquation> NSCLC were enrolled and randomly assigned to the control group (tislelizumab + chemotherapy), low-molecular-weight heparin (LMWH) group (LMWH + tislelizumab + chemotherapy), and rivaroxaban group (rivaroxaban + tislelizumab + chemotherapy). The primary endpoint was progression-free survival (PFS), and the secondary endpoints were objective response rate (ORR), disease control rate (DCR), and safety. Results In this study, 143 patients were enrolled, including 46 in the control group, 48 in the LMWH group, and 49 in the rivaroxaban group. The median PFS of the control, LMWH, and rivaroxaban groups was 8.5 months (95%CI: 7.6–9.4), 8.6 months (95% CI: 8.1–9.1), and 11.2 months (95% CI: 9.4–13.0), respectively. Kaplan–Meier curve analysis showed no significant difference in PFS between the LMWH and control groups (HR = 1.041, 95% CI: 0.676–1.604; P = 0.852). The rivaroxaban group had significantly higher PFS than the control (HR = 0.766, 95% CI: 0.623–0.967; P = 0.021) and LMWH groups (HR = 0.582, 95% CI: 0.376–0.901; P = 0.013). No significant differences were observed in the ORR, complete response, partial response, DCR, or stable disease among the three groups (all P > 0.05). Conclusions Rivaroxaban combined with immune checkpoint inhibitors and chemotherapy has potential advantages in NSCLC treatment. It may enhance the antitumor efficacy by regulating immune functions, thereby prolonging the PFS of patients. Trial registration Trial Registration: ChiCTR2500106653.

Efficacy and safety of low-molecular-weight heparin or rivaroxaban combined with immunotherapy and chemotherapy in the treatment of advanced nonsmall cell lung cancer: a prospective, randomized, controlled clinical study

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2025年11月12日

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Hongchuan Zhang,
Junfeng Li,
Guangjin Yuan,
Shengyuan Huang,
Xuemei Li

摘要

Objective

This study aimed to observe and compare the efficacy and safety of different anticoagulants combined with immunotherapy and chemotherapy for advanced nonsmall cell lung cancer (NSCLC).

Methods

In this prospective, randomized, controlled clinical trial, treatment-naïve subjects with stage $\text{I}\!\text{I}\!\text{I}$ $I I I$ B– $\text{I}\!\text{V}$ $I V$ NSCLC were enrolled and randomly assigned to the control group (tislelizumab + chemotherapy), low-molecular-weight heparin (LMWH) group (LMWH + tislelizumab + chemotherapy), and rivaroxaban group (rivaroxaban + tislelizumab + chemotherapy). The primary endpoint was progression-free survival (PFS), and the secondary endpoints were objective response rate (ORR), disease control rate (DCR), and safety.

Results

In this study, 143 patients were enrolled, including 46 in the control group, 48 in the LMWH group, and 49 in the rivaroxaban group. The median PFS of the control, LMWH, and rivaroxaban groups was 8.5 months (95%CI: 7.6–9.4), 8.6 months (95% CI: 8.1–9.1), and 11.2 months (95% CI: 9.4–13.0), respectively. Kaplan–Meier curve analysis showed no significant difference in PFS between the LMWH and control groups (HR = 1.041, 95% CI: 0.676–1.604; P = 0.852). The rivaroxaban group had significantly higher PFS than the control (HR = 0.766, 95% CI: 0.623–0.967; P = 0.021) and LMWH groups (HR = 0.582, 95% CI: 0.376–0.901; P = 0.013). No significant differences were observed in the ORR, complete response, partial response, DCR, or stable disease among the three groups (all P > 0.05).

Conclusions

Rivaroxaban combined with immune checkpoint inhibitors and chemotherapy has potential advantages in NSCLC treatment. It may enhance the antitumor efficacy by regulating immune functions, thereby prolonging the PFS of patients.

Trial registration

Trial Registration: ChiCTR2500106653.