Camrelizumab plus famitinib as first-line treatment for locally advanced or metastatic pulmonary sarcomatoid carcinomas (CAPSTONE): a multi-center, single-arm, phase 2 trial
Abstract
Background: The combination of immune checkpoint inhibitors and antiangiogenic agents has demonstrated a synergistic antitumor effect in numerous solid tumors, but has rarely been investigated in pulmonary sarcomatoid carcinoma (PSC). We assessed the activity and safety of camrelizumab (a programmed cell death-1 inhibitor) plus famitinib (an antiangiogenic agent) in patients with PSC. Methods: CAPSTONE is an open-label, single-arm, Simon two-stage, phase 2 trial done at eight sites in China. Eligible patients were aged between 18 and 75 years and had previously untreated stage IIIB–IV pulmonary sarcomatoid carcinoma, an Eastern Cooperative Oncology Group performance status of 0 or 1, and at least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Patients received intravenous camrelizumab 200 mg every 3 weeks and oral famitinib 20 mg once daily until disease progression or intolerable toxicity. The primary endpoint was confirmed objective response rate (ORR) as per RECIST version 1.1 in the full analysis set, which included all patients who received at least one dose of study drug. Safety was assessed in all as-treated patients. This study is registered at ClinicalTrials.gov , NCT04888429 , and enrollment is complete. Findings: Between August 4, 2021 and March 21, 2024, 28 patients were enrolled. With a median follow-up of 18.1 months, the confirmed ORR was 42.9% (95% confidence interval [CI] 24.5–62.8). The disease control rate was 85.7% (95% CI 67.3–96.0). The median duration of response was 16.0 months (95% CI 5.0–29.9); the median progression-free survival was 7.1 months (95% CI 3.5–12.5); and the median overall survival was 18.1 months (95% CI 10.3–28.1). Treatment-related adverse events (TRAEs) of grade 3 or more were observed in 10 (35.7%) patients, the most common being decreased platelet count (four [14.3%]) and decreased neutrophil count (three [10.7%]). Three (10.7%) patients discontinued camrelizumab, and three (10.7%) discontinued famitinib due to TRAEs. Two patients died of unknown cause, which were assessed by the investigator as possibly related to study treatment. Interpretation: Camrelizumab plus famitinib showed antitumor activity in patients with locally advanced or metastatic PSC. This combination may be a potential first-line option for this patient population, and warrants further investigation in a large-sample trial. Funding: National Science and Technology Major Project of the Ministry of Science and Technology of China (No. 2024ZD0519700), National Natural Science Foundation of China (62131009, 82472969), Innovation Research Group Program of the Natural Science Foundation of Hubei Province (2026AFA036), Hubei Provincial Health Science and Technology Innovation and Achievement Transformation Project , Jiangsu Hengrui Pharmaceuticals Co., Ltd .
Related
- Surufatinib and camrelizumab plus nab-paclitaxel–gemcitabine as first-line treatment for metastatic pancreatic ductal adenocarcinoma: a retrospective cohort study
- Real-world comparative outcomes of first-line immune combinations (ICI-ICI vs ICI-TKI) in metastatic renal cell carcinoma with sarcomatoid features.
- An Exploratory Study of ABT-806, a Tumor-Specific Anti-EGFR Antibody, in Subjects with Recurrent or Metastatic Head and Neck and Other Squamous Cell Carcinomas
- A randomized, placebo-controlled, phase II study of docetaxel and platinum with or without erlotinib in recurrent/metastatic head and neck squamous-cell carcinomas.
- Treatment Patterns and Survival in Older Patients with FIGO Stage IIB–IV Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Carcinomas
BibTeX
@article{jiang2026camrelizumab,
title = {{Camrelizumab plus famitinib as first-line treatment for locally advanced or metastatic pulmonary sarcomatoid carcinomas (CAPSTONE): a multi-center, single-arm, phase 2 trial}},
author = {Jizong Jiang and Yuxuan Wei and Bin Yang and Xianling Liu and Shundong Cang and Qibin Song and Huijuan Wang and Zheng Jin and Jun Wang and Feng Ye and Fenglin She and Hongyi Kou and Bo Zhu and Qian Chu},
journal = {eClinicalMedicine},
year = {2026},
month = oct,
doi = {10.1016/j.eclinm.2026.104285},
url = {https://linkinghub.elsevier.com/retrieve/pii/S2589537026005389},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Camrelizumab plus famitinib as first-line treatment for locally advanced or metastatic pulmonary sarcomatoid carcinomas (CAPSTONE): a multi-center, single-arm, phase 2 trial
AU - Jizong Jiang
AU - Yuxuan Wei
AU - Bin Yang
AU - Xianling Liu
AU - Shundong Cang
AU - Qibin Song
AU - Huijuan Wang
AU - Zheng Jin
AU - Jun Wang
AU - Feng Ye
AU - Fenglin She
AU - Hongyi Kou
AU - Bo Zhu
AU - Qian Chu
PY - 2026
DA - 2026/10/24
JO - eClinicalMedicine
DO - 10.1016/j.eclinm.2026.104285
UR - https://linkinghub.elsevier.com/retrieve/pii/S2589537026005389
AB - Background: The combination of immune checkpoint inhibitors and antiangiogenic agents has demonstrated a synergistic antitumor effect in numerous solid tumors, but has rarely been investigated in pulmonary sarcomatoid carcinoma (PSC). We assessed the activity and safety of camrelizumab (a programmed cell death-1 inhibitor) plus famitinib (an antiangiogenic agent) in patients with PSC. Methods: CAPSTONE is an open-label, single-arm, Simon two-stage, phase 2 trial done at eight sites in China. Eligible patients were aged between 18 and 75 years and had previously untreated stage IIIB–IV pulmonary sarcomatoid carcinoma, an Eastern Cooperative Oncology Group performance status of 0 or 1, and at least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Patients received intravenous camrelizumab 200 mg every 3 weeks and oral famitinib 20 mg once daily until disease progression or intolerable toxicity. The primary endpoint was confirmed objective response rate (ORR) as per RECIST version 1.1 in the full analysis set, which included all patients who received at least one dose of study drug. Safety was assessed in all as-treated patients. This study is registered at ClinicalTrials.gov , NCT04888429 , and enrollment is complete. Findings: Between August 4, 2021 and March 21, 2024, 28 patients were enrolled. With a median follow-up of 18.1 months, the confirmed ORR was 42.9% (95% confidence interval [CI] 24.5–62.8). The disease control rate was 85.7% (95% CI 67.3–96.0). The median duration of response was 16.0 months (95% CI 5.0–29.9); the median progression-free survival was 7.1 months (95% CI 3.5–12.5); and the median overall survival was 18.1 months (95% CI 10.3–28.1). Treatment-related adverse events (TRAEs) of grade 3 or more were observed in 10 (35.7%) patients, the most common being decreased platelet count (four [14.3%]) and decreased neutrophil count (three [10.7%]). Three (10.7%) patients discontinued camrelizumab, and three (10.7%) discontinued famitinib due to TRAEs. Two patients died of unknown cause, which were assessed by the investigator as possibly related to study treatment. Interpretation: Camrelizumab plus famitinib showed antitumor activity in patients with locally advanced or metastatic PSC. This combination may be a potential first-line option for this patient population, and warrants further investigation in a large-sample trial. Funding: National Science and Technology Major Project of the Ministry of Science and Technology of China (No. 2024ZD0519700), National Natural Science Foundation of China (62131009, 82472969), Innovation Research Group Program of the Natural Science Foundation of Hubei Province (2026AFA036), Hubei Provincial Health Science and Technology Innovation and Achievement Transformation Project , Jiangsu Hengrui Pharmaceuticals Co., Ltd .
SN - 2589-5370
ER -