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Sarcomatoid Carcinoma of LungPhase 2CAPSTONENCT04888429

Camrelizumab Plus Famitinib as Treatment in Patient With Advanced or Metastatic Pulmonary Sarcomatoid Carcinoma

A Phase 2 study testing Camrelizumab and Famitinib in people with Sarcomatoid Carcinoma of Lung, run by Qian Chu at 8 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single arm, multi-center clinical trial. Target population is patients with Advanced or Metastatic Pulmonary Sarcomatoid Carcinoma，aiming to evaluate the efficacy and safety of the combination therapy of Camrelizumab and famitinib . Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Sarcomatoid Carcinoma of Lung
What is being tested?
Camrelizumab and Famitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
8 sitesChina
Study dates
19 Jul 2021to 30 Jun 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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；

Who cannot join

  • 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) ；
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  • 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 ;

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

China8 sites

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

  • The First Affiliated Hospital of Shandong First Medical University

    Jinan, Shandong

  • Qian Chu

    Wuhan, Hubei, 430000

  • Hubei Cancer Hospital

    Wuhan, Hubei

  • Renmin Hospital of Wuhan University Hubei General Hospital

    Wuhan, Hubei

  • The first Affiliated Hospital of Xiamen University

    Xiamen, Fujian

  • Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University

    Zhengzhou, Henan

  • Henan Provincial People's Hospital

    Zhengzhou, Henan

Other trials in China

About this study

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

This is a single arm, multi-center clinical trial. Target population is patients with Advanced or Metastatic Pulmonary Sarcomatoid Carcinoma，aiming to evaluate the efficacy and safety of the combination therapy of Camrelizumab and famitinib . Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody, and famitinib is an orally bioavailable receptor tyrosine kinase (RTK) inhibitor.

Read the detailed description

This trial enrolled patients with advanced or metastatic pulmonary sarcomatoid carcinoma. Patients will receive camrelizumab 200 mg every 3 weeks and famitinib 20 mg once per day. The primary endpoint is objective response rate (ORR) assessed by investigators per RECIST version 1.1. Key secondary endpoints were progression-free survival (PFS), overall survival (OS), duration of response, and safety.

Being tested
Camrelizumab, Famitinib
Keywords
Sarcomatoid Carcinoma of Lung, Camrelizumab, Famitinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CamrelizumabDrug

    Also called SHR-1210

    Patients received camrelizumab 200 mg every 3 weeks

  • FamitinibDrug

    Also called SHR-1020

    Patients received Famitinib 20 mg once per day

Study groups in NCT04888429
Study groupRoleWhat they receive
Camrelizumab + FamitinibExperimentalPatients received camrelizumab 200 mg every 3 weeks and famitinib 20 mg once per day.
Receives: Drug: Camrelizumab; Drug: Famitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    Objective Response Rate using RECIST 1.1 criteria, Proportion of patients with CR and PR

    Measured: about 24 month

Secondary outcomes (5)

  1. Progression-free Survival

    Time from the date of first dose to first observation of progression (RECIST1.1) or date of death (from any cause)

    Measured: about 24 month

  2. Overall Survival

    Time from the date of first dose to death from any cause

    Measured: about 24 month

  3. Duration of response

    Time from the date of the first documented response (CR or PR) to the earliest date of disease progression (RECIST 1.1), or death due to any cause.

    Measured: about 24 month

  4. incidence, type and severity of adverse events

    Descriptive statistics of safety will be presented using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0

    Measured: From time of informed consent through treatment period and up to 30 days post last dose of study treatment (about 24 months)

  5. Disease control rate

    Disease control rate using RECIST 1.1 criteria, Proportion of patients with CR, PR and SD

    Measured: about 24 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2021
  2. Study start19 Jul 2021
  3. Primary completion30 Dec 2024
  4. Study completion30 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04888429
Sponsor's protocol ID
S037
Acronym
CAPSTONE
Status last verified
Oct 2026
First submitted
12 May 2021
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Jiang J, Wei Y, Yang B, Liu X, Cang S, Song Q, Wang H, Jin Z, Wang J, Ye F, She F, Kou H, Zhu B, Chu Q. Camrelizumab plus famitinib as first-line treatment for locally advanced or metastatic pulmonary sarcomatoid carcinomas (CAPSTONE): a multi-center, single-arm, phase 2 trial. EClinicalMedicine. 2026 Oct 24;101:104285. doi: 10.1016/j.eclinm.2026.104285. eCollection 2026 Nov.

    PubMed 42964339

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab and Famitinib in people with Sarcomatoid Carcinoma of Lung, run by Qian Chu at 8 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: about 24 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04888429, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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