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Non-Small Cell Lung CancerPhase 2Compass-001NCT04167774

A Study to Evaluate Camrelizumab in Combination With Nb-Paclitaxel in Patients With Advanced or Metastatic NSCLC

A Phase 2 study testing Camrelizumab and nb-Paclitaxel in people with Non-Small Cell Lung Cancer, run by Sun Yat-sen University at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to explore the efficacy and safety of Camrelizumab in combination with nb-Paclitaxel in treating patients with recurrent/metastatic non-small-cell lung cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Camrelizumab and nb-Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
3 sitesChina
Study dates
30 Jul 2019to 30 Sep 2022
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and Female ≥ 18 years of age
  • Subjects enrolled must have histologically-confirmed or cytologically confirmed diagnosis of stage ⅢB,Ⅳnon-small cell lung cancer（NSCLC）,at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST)
  • Disease progression experienced during or after one prior platinum containing doublet chemotherapy（excluding taxane chemotherapy）
  • Subjects must have had no more than one prior systemic chemotherapeutic regimen Note: a. Replacement of platinum drugs for toxicity is considered as a systemic chemotherapeutic regimen; b.Subjects with recurrent disease > 6 months after Postoperative adjuvant platinum based chemotherapy, who also subsequently progressed during or after a platinum-doublet regimen given to treat the recurrence, are eligible.
  • Life expectancy ≥ 12 weeks.
  • ECOG performance status of 0 or 1.
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  • The main organ's function is normal and it should meet the following criteria:
  • Blood routine examination should be complied with (No blood transfusion, no use of hematopoietic factors and no use of drugs for correction within 14 days):
  • ANC ≥ 1.5×109/L；
  • PLT ≥ 100×109/L；
  • HB ≥ 90 g/L；
  • ALB ≥ 30 g/L
  • TSH ≤ ULN (however, patients with free Triiodothyronine [FT3] or free Thyroxine [FT4] levels ≤ ULN may be enrolled)
  • TBIL ≤ULN；
  • ALT、AST≤ 1.5 ULN
  • AKP≤2.5 ULN
  • Cr≤1.5ULN，endogenous creatinine clearance rate≥60ml/min(Cockcroft-Gault formula);
  • Women of childbearing age must undergo a serological pregnancy test within 7 days before the first dose with negative results and willing to use a medically approved and effective contraceptive method (e.g. intrauterine device, contraceptive pill or condom) during the study and within two months after the last dose. For male subjects whose partners are women of childbearing age, they should be sterilized surgically or agree to use effective contraceptive methods during the study and within two months after the last dose.
  • Subjects should be voluntarily participate in clinical studies and informed consent should be signed.

Who cannot join

  • Subjects have a history of any active autoimmune disease or autoimmune disease including but not limited to the following: autoimmune hepatitis,interstitial pneumonia,uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism which can be included after hormone replacement therapy; Subjects with childhood asthma have been completely alleviated and without any intervention or vitiligo in adulthood can be included. Subjects who need medical intervention with bronchodilators can not be included.
  • Participated in other clinical trials, or finish other clinical trials within 4 weeks.
  • Known history of hypersensitivity to any components of the Camrelizumab formulation，or other monoclonal antibody.
  • Known history of hypersensitivity to paclitaxel or albumin human .
  • Peripheral blood neutrophils <1500/mm3
  • Subjects with epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) translocation.
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  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least two months prior to the first dose of trial treatment and any Neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 14 days prior to trial treatment.
  • Clinically significant cardiovascular diseases, including but not limited to congestive heart failure (New York heart association (NYHA) class > 2), unstable or severe angina, severe acute myocardial infarction within 1 year before enrollment, supraventricular or ventricular arrhythmia which need medical intervention.
  • Subjects with congenital or acquired immunodeficiency such as HIV infection, active hepatitis B (HBV DNA ≥ 2000 IU/ml), hepatitis C (hepatitis C antibody is positive).
  • Subjects with other factors that might lead to the termination of the study, such as serious diseases (including mental illness) requiring combined treatment, severe laboratory abnormality, and family or social factors，which will affect the safety of the subjects, or the collection of data and samples. in the opinion of the treating Investigator.

Trial locations and contacts

3 sites in 1 country.

Xiuyu Cai, MD contact

+86-13580569326

caixy_84@outlook.com

China3 sites, 3 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000

    Xiuyu Cai, MD, caixy_84@outlook.com

    Recruiting

  • The first affiliated hospital of guangzhou medical university

    Guangzhou, Guangdong, 510000

    Wenhua Liang, MD

    Recruiting

  • The First Affiliated Hospital/School of Clinical Medicine of Guangdong Pharmaceutical University

    Guangzhou, Guangdong, 510000

    Xicheng Wang, MD

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Camrelizumab Combined With Nb-Paclitaxel in Patients With Recurrent/Metastatic Non-small-cell Lung Cancer After the Failure of Platinum-based Therapy

The purpose of this study is to explore the efficacy and safety of Camrelizumab in combination with nb-Paclitaxel in treating patients with recurrent/metastatic non-small-cell lung cancer.

Read the detailed description

Camrelizumab is a humanized monoclonal antibody against Programmed death 1(PD-1). Albumin-bound paclitaxel is a new nano-paclitaxel drug coated with human albumin. Patients with recurrent/metastatic non-small-cell lung cancer after the failure of platinum-based therapy will received Camrelizumab 200mg((3mg/kg for underweight patients) iv and nb-Paclitaxel 260mg/m2 iv every 3 weeks. The efficacy and safety will be observed.

Being tested
Camrelizumab, nb-Paclitaxel
Keywords
Immune Checkpoint Inhibitor, nb-Paclitaxel
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • CamrelizumabDrug

    Also called Camrelizumab for Injection

    Camrelizumab will be administered as a 30-minute IV infusion Q3W at a dose of 200mg (3mg/kg for underweight patients).

  • nb-PaclitaxelDrug

    Also called Paclitaxel for Injection(Albumin Bound)

    nb-Paclitaxel will be administered as a 30-minute IV infusion Q3W at a dose of 260mg/m2 for 4-6 cycles.

Study groups in NCT04167774
Study groupRoleWhat they receive
Camrelizumab +nb-PaclitaxelExperimentalParticipants receive Camrelizumab 200mg(3mg/kg for underweight patients) iv and nb-Paclitaxel 260mg/m2 iv every 3 weeks until disease progression or unacceptable toxicity
Receives: Drug: Camrelizumab; Drug: nb-Paclitaxel

What is being measured

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

  1. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

    Measured: Up to approximately 12 months

Secondary outcomes (6)

  1. 12-month PFS rate

    The rate of 12-month PFS

    Measured: From date of enrollment up to 12 months

  2. Progression-free Survival (PFS)

    Progression-free survival is defined as the duration from date of enrollment to the first occurrence of progression of disease or death from any cause

    Measured: Time Frame: Up to approximately 24 months

  3. Overall survival (OS)

    Overall survival is defined as the duration from date of enrollment to the date of death from any cause.

    Measured: Up to approximately 24 months

  4. Duration of Response (DCR)

    DCR is defined as the percentage of participants in the analysis population who have a CR, PR or stable disease (SD) per RECIST 1.1.

    Measured: Up to approximately 24 months

  5. Duration of Response (DOR)

    DOR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.

    Measured: Up to approximately 24 months

  6. Incidence of Adverse Events (AEs) in the treatment of Camrelizumab in combination with nb-Paclitaxel

    Number of participants with adverse events occurring up to 30 days after the last administration are evaluated and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.

    Measured: Up to approximately 24 months

Timeline

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

  1. First posted19 Nov 2019
  2. Study start30 Jul 2019
  3. Primary completion30 Jun 2022 (estimated)
  4. Study completion30 Sep 2022 (estimated)

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
62 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04167774
Sponsor's protocol ID
Compass-001
Acronym
Compass-001
Status last verified
Nov 2019
First submitted
15 Nov 2019
Last updated
22 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Update after discussion

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab and nb-Paclitaxel in people with Non-Small Cell Lung Cancer, run by Sun Yat-sen University at 3 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 19 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Results are not available in the source record.

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

Contact Xiuyu Cai, MD (+86-13580569326, caixy_84@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to approximately 12 months). 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 NCT04167774.

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 22 Nov 2019.

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