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Advanced NSCLCPhase 3NCT05106335

A Study to Evaluate Camrelizumab Combined With Famitinib as Subsequent Therapy in Patients With Advanced NSCLC

A Phase 3 study testing camrelizumab + famitinib, famitinib and docetaxel in people with Advanced NSCLC, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a randomized, open-label, international, multi-center, phase III trial to evaluate the efficacy, and safety of camrelizumab combined with famitinib malate versus docetaxel as subsequent therapy in Advanced NSCLC. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced NSCLC
What is being tested?
camrelizumab + famitinib, famitinib and docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteChina
Study dates
6 Jan 2022to 11 May 2022
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed metastatic or recurrent non-small cell lung cancer.
  • Failed previous platinum-based chemotherapy and anti-PD-(L)1 monoclonal antibody treatment.
  • Have measurable disease based on RECIST v1.1.
  • ECOG PS score: 0-1.
  • Expected survival ≥ 3 months.
  • Non-surgically sterilized female subjects or women of childbearing potential must be negative for a serum pregnancy test within 3 days prior to the first dose and must be non-lactating. Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to take highly effective contraceptive measures during the study period and until 6 months after the last study dose.
  • Subjects must participate voluntarily, sign the ICF, have good compliance, and cooperate with follow-up visits.

Who cannot join

  • Have uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites.
  • Have known history of prior malignancy in the past 3 years.
  • Have active pulmonary tuberculosis.
  • Have clinical symptoms of the heart or heart diseases that are not well controlled.
  • Have hypertension which cannot be well controlled by antihypertensives
  • Urinalysis has indicated that the urine protein is ≥ ++ and quantitative test of urine protein has confirmed that the 24-h urine protein is > 1.0 g.
Show all 12Show fewer
  • Have a thrombosis tendency or are currently receiving thrombolysis/anticoagulation therapy.
  • Have received major surgery within 4 weeks prior to randomization; or palliative radiotherapy within 2 weeks prior to randomization; or have not recovered from the toxicities and/or complications of previous interventions to NCI-CTCAE Grade ≤ 1.
  • Have known history of arterial/venous thrombosis within 6 months prior to randomization, such as cerebrovascular accidents, deep vein thrombosis and pulmonary embolism.
  • Are currently participating and receiving study therapy or have participated in a study and received the last dose of study drug within 4 weeks (or 5 half-lives of the study drug) prior to randomization.
  • Previous treatment with camrelizumab, docetaxel, and small-molecule VEGFR inhibitors including famitinib.
  • Have other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Subei People's Hospital of Jiangsu Province

    Yangzhou, Jiangsu, 225001

Other trials in China

About this study

Official title: A Randomized, Open-Label, Controlled, Multi-Center Phase III Clinical Study of Camrelizumab Combined With Famitinib Malate Versus Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer Who Progressed on Prior Immune Checkpoint Inhibitor Treatment and Platinum-Based Chemotherapy

This is a randomized, open-label, international, multi-center, phase III trial to evaluate the efficacy, and safety of camrelizumab combined with famitinib malate versus docetaxel as subsequent therapy in Advanced NSCLC.

Conditions
Advanced NSCLC
Being tested
camrelizumab + famitinib, famitinib, docetaxel

What participants receive

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

  • camrelizumab + famitinibDrug

    camrelizumab for intravenous injection; famitinib malate capsules for oral administration

  • famitinibDrug

    famitinib malate capsules for oral administration

  • docetaxelDrug

    docetaxel for intravenous injection

Study groups in NCT05106335
Study groupRoleWhat they receive
Treatment Arm AExperimentalcamrelizumab + famitinib
Receives: Drug: camrelizumab + famitinib
Treatment Arm CExperimentalfamitinib
Receives: Drug: famitinib
Treatment Arm BActive comparatordocetaxel
Receives: Drug: docetaxel

What is being measured

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

  1. OS

    OS is the time interval from the date of randomization to death due to any reason or lost of follow-up.

    Measured: up to 4 years

Secondary outcomes (5)

  1. PFS

    Progression-Free-Survival, defined as the time from randomization to the first occurrence of disease progression with use of RECIST v1.1 or death from any cause, whichever occurs first.

    Measured: up to 4 years

  2. ORR

    Objective Response Rate, determined using RECIST v1.1 criteria, defined as best overall response (CR or PR) across all assessment time points.

    Measured: up to 4 years

  3. DoR

    Duration of Response, determined using RECIST v1.1 criteria.

    Measured: up to 4 years

  4. DCR

    Disease Control Rate, determined using RECIST v1.1 criteria.

    Measured: up to 4 years

  5. TTF

    Time to Treatment Failure, defined as the time from randomization to treatment discontinuation.

    Measured: up to 4 years

Timeline

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

  1. First posted3 Nov 2021
  2. Study start6 Jan 2022
  3. Primary completion11 May 2022
  4. Study completion11 May 2022

Why it stopped: Sponsor R \& D Strategy Adjustment

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Camrelizumab Combined with Famitinib Malate Versus Docetaxel
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05106335
Sponsor's protocol ID
SHR-1210-III-332
Status last verified
Aug 2023
First submitted
22 Oct 2021
Last updated
16 Aug 2023
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing camrelizumab + famitinib, famitinib and docetaxel in people with Advanced NSCLC, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site 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 12 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: stopped early, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was stopped early (reason given: Sponsor R \& D Strategy Adjustment). Results are not available in the source record.

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?

OS (time frame: up to 4 years). 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 NCT05106335.

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 16 Aug 2023.

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