Combination therapy of Camrelizumab and Famitinib for advanced lung sarcomatoid carcinoma

Camrelizumab Plus Famitinib as Treatment in Patient With Advanced or Metastatic Pulmonary Sarcomatoid Carcinoma：A Multi-center, Single-arm Study

This study is testing a new combination of two drugs, Camrelizumab and Famitinib, to see if they can help people with advanced lung sarcomatoid carcinoma feel better and live longer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tongji Hospital (Academic / other)
• Drugs / interventions: Camrelizumab, famitinib, chemotherapy, Prednisone
• Locations: 8 sites (Xiamen, Fujian and 7 other locations)
• Trial ID: NCT04888429 on ClinicalTrials.gov

What this trial studies

This clinical trial is a single-arm, multi-center investigation aimed at evaluating the efficacy and safety of the combination of Camrelizumab, a humanized anti-PD1 monoclonal antibody, and Famitinib, an orally bioavailable receptor tyrosine kinase inhibitor, in patients with advanced or metastatic pulmonary sarcomatoid carcinoma. Participants will receive Camrelizumab every three weeks and Famitinib daily, with the primary endpoint being the objective response rate assessed by RECIST criteria. Secondary endpoints include progression-free survival, overall survival, duration of response, and safety profiles of the treatment. The trial seeks to provide insights into the potential benefits of this combination therapy for a challenging cancer type.

Who should consider this trial

Good fit: Ideal candidates include patients with advanced or metastatic pulmonary sarcomatoid carcinoma who have not received prior systemic therapy and meet specific eligibility criteria.

Not a fit: Patients with prior systemic therapy or those with significant tumor invasion as indicated by imaging may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced pulmonary sarcomatoid carcinoma, potentially improving their outcomes.

How similar studies have performed: Other studies have shown promise with similar immunotherapy and targeted therapy combinations, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Patients with histologically stage IIIB, IIIC, IV Pulmonary Sarcomatoid Carcinoma according to WHO criteria or diagnosed with non-small cell lung cancer with sarcomatoid carcinoma component (sarcomatoid component tumour cells can be spindle cells, and/or giant cells and/or heterogenous sarcomatous differentiation including rhabdomyosarcoma, chondrosarcoma, etc.) ；
* Has no prior systemic therapy; (chemotherapy and/or radiotherapy is allowed as part of neoadjuvant/adjuvant therapy. Patients who have had recurrence or metastasis for more than 6 months from the end of neoadjuvant/adjuvant treatment would be enrolled ) ；
* Patients must have at least one measurable lesion according to RECIST 1.1 ；
* ECOG score 0-1 ；
* Agree to provide tumour tissue samples for biomarker exploration (including but not limited to PD-L1 IHC or NGS testing) ；
* Life expectancy more than 3 months;
* Has adequate organ function；

Exclusion Criteria:

* Imaging (CT or MRI) showed tumor invasion of major vessels. hemoptysis ≥ 2.5 mL within 1 month before the first dose;
* Patients with EGFR-sensitive mutation (19Exondel/L858R), ALK, ROS1 gene rearrangement or fusion, BRAFV600E mutation, MET gene exon 14 skipping mutation;
* Patients with active bleeding or bleeding tendency ；
* With hypertension that cannot be reduced to the normal range after antihypertensive drug treatment (systolic blood pressure ≤ 140 mmHg/diastolic blood pressure ≤ 90 mmHg)；
* Urine protein ≥ (+ +), and 24-hour urine protein ≥ 1.0g;
* Presence of thrombotic disorder requiring anticoagulant therapy with warfarin or heparin, or requiring antiplatelet therapy (aspirin ≥ 300 mg/day or clopidogrel ≥ 75 mg/day) ；
* Has multiple factors affecting the absorption of oral drugs, such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction
* Has active central nervous system (CNS) metastases confirmed by CT or MRI
* Subjects diagnosed immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy of non-related tumor within 7 days before the first dose; allowed physiological dose of glucocorticoid (≤10 mg/day Prednisone or equivalent);
* Has active hepatitis B ;
* Has severe infections within 4 weeks of the first dose of study treatment ;
* Women who are pregnant or lactating ;
* With grade II or above myocardial ischemia or myocardial infarction and poorly controlled arrhythmias (QTc interval ≥ 450 ms for males and QTc interval ≥ 470 ms for females). Subjects with grade III-IV cardiac insufficiency or with left ventricular ejection fraction (LVEF) less than 50% according to NYHA criteria;
* Has known history of Human Immunodeficiency Virus (HIV)；
* Has known allergy to Camrelizumab, or famitinib or any of accessories ;

Where this trial is running

Xiamen, Fujian and 7 other locations

• The first Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (Active_not_recruiting)
• Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (Recruiting)
• Qian Chu — Wuhan, Hubei, China (Recruiting)
• Hubei Cancer Hospital — Wuhan, Hubei, China (Recruiting)
• Renmin Hospital of Wuhan University Hubei General Hospital — Wuhan, Hubei, China (Recruiting)
• The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)
• The First Affiliated Hospital of Shandong First Medical University — Jinan, Shandong, China (Active_not_recruiting)

Study contacts

• Principal investigator: Qian Chu — Tongji Hospital
• Study coordinator: Qian Chu

Conditions Sarcomatoid Carcinoma of Lung; Camrelizumab; Famitinib