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Small-cell Lung CancerPhase 2NCT04683198

Camrelizumab Combined With Apatinib ,Carboplatin and Etoposide in Participants With ES-SCLC

A Phase 2 study testing camrelizumab, Apatinib Mesylate and Carboplatin in people with Small-cell Lung Cancer, run by Chinese Academy of Medical Sciences.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This single-arm, Phase II, multicenter study was designed to evaluate the safety and efficacy of Camrelizumab (anti-programmed death-receptor 1 [PD-1] antibody) in combination with Apatinib+carboplatin plus (+) etoposide in chemotherapy-naive participants with ES-SCLC. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Small-cell Lung Cancer
What is being tested?
camrelizumab, Apatinib Mesylate and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
No sites listed yet
Study dates
1 Apr 2021to 30 Jun 2024
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 and 70 years old
  • Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system);
  • No prior systemic treatment for ES-SCLC；
  • Has received radiotherapy and chemotherapy for limited stage SCLC must have received definitive treatment, and has at least 6 months of no treatment interval from the last treatment to the diagnosis of extensive SCLC
  • Eastern Cooperative Oncology Group performance status of 0 or 1；
  • life expectancy≥ 12 weeks
  • Adequate hematologic and organ function
  • Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 90 days after the last dose of study (such as intrauterine devices , contraceptives or condoms) ; No pregnant or breastfeeding women, and a negative pregnancy test are received within 72h before the first dose of the study.

Who cannot join

  • Has prior therapy with apatinib,anlotinib, anti-programmed cell death (PD)-1, anti-PD-L1 or other immunotherapy against PD-1/PD-L1;
  • Has active or untreated central nervous system (CNS) metastases and/or cancerous meningitis;
  • Has spinal cord compression which was not cured or relieved through surgery and/or radiotherapy, or diagnosed spinal cord compression after treatment showed no clinical evidence of disease stabilization prior to allocation ≥1 week;
  • Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear;
  • Active autoimmune diseases requiring systemic treatment occurred within 2 years prior to first administration ;
  • Immunosuppressive therapy with immunosuppressive agents or systemic or absorbable local hormones (dosage > 10 mg/day prednisone or other therapeutic hormones) is required for the purpose of immunosuppression, and is still in use for 2 weeks after the first administration;
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  • Has arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident including transient ischemic attack, deep vein thrombosis and pulmonary embolism;
  • Within 3 months prior to initial administration, subjects with evidence of bleeding had clinical significance or history of bleeding tendency, regardless of severity;
  • Has vaccinated with vaccines or attenuated vaccines within 4 weeks prior to first administration
  • Has major surgical procedure、biopsy or obvious traumatic injury within 28 days before allocation;
  • Has participated in other anticancer drug clinical trials within 4 weeks;
  • Has diagnosed and/or treated additional malignancy within 5 years prior to allocation. Exceptions include cured basal cell carcinoma of skin and carcinoma in situ of cervix;
  • Has any severe and/or uncontrolled disease;
  • Has adverse events caused by previous therapy except alopecia that did not recover to ≤ grade 1;
  • Has drug abuse history that unable to abstain from or mental disorders; 13. Has any severe and/or uncontrolled disease;
  • Severe hypersensitivity occurs after administration of other monoclonal antibodies;
  • According to the judgement of the researchers, there are other factors that may lead to the termination of the study.

About this study

Official title: A Single -Arm, Open-label, Multicenter Phase II Study of Camrelizumab Combined With Apatinib ,Carboplatin and Etoposide in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)

This single-arm, Phase II, multicenter study was designed to evaluate the safety and efficacy of Camrelizumab (anti-programmed death-receptor 1 [PD-1] antibody) in combination with Apatinib+carboplatin plus (+) etoposide in chemotherapy-naive participants with ES-SCLC. Participants will be receive camrelizumab +apatinib+ carboplatin + etoposide on 21-day cycles for four -six cycles in the induction phase followed by maintenance with camrelizuab +apatinib until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.

Being tested
camrelizumab, Apatinib Mesylate, Carboplatin, Etoposide
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

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

  • camrelizumabDrug

    Also called SHR-1210

    Camrelizumab intravenous infusion was administered at a dose of 200 mg on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4/6) and maintenance phase ,until PD.

  • Apatinib MesylateDrug

    Apatinib capsules 250 mg given orally , once daily in 21-day cycle and maintenance phase,until PD.

  • CarboplatinDrug

    Carboplatin intravenous infusion to achieve an initial target AUC of 5 mg/mL/min was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4/6).

  • EtoposideDrug

    Etoposide intravenous infusion was administered at a dose of 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle during the induction phase (Cycles 1-4/6).

Study groups in NCT04683198
Study groupRoleWhat they receive
Experimental: camrelizumab +apatinib+ Carboplatin + EtoposideExperimentalInduced stage：camrelizumab 200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus Apatinib capsules 250 mg given orally +Etoposide (100mg/m2 IV continuously on Day 1, 2 and 3）+Carboplatin（AUC 5 mg/mL/min IV on Day 1 ; maintenance stage：Camrelizumab 200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus Apatinib capsules 250 mg given orally, once daily in 21-day cycle .
Receives: Drug: camrelizumab; Drug: Apatinib Mesylate; Drug: Carboplatin; Drug: Etoposide

What is being measured

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

  1. Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least 20% increase in the sum of the longest diameter of target lesions compared to baseline, or unequivocal progression in non-target lesion(s), or the appearance of new lesion(s).

    Measured: Baseline until PD or death, whichever occurs first (up to approximately 13 months)

Secondary outcomes (5)

  1. Overall survival (OS)

    Baseline until death from any cause

    Measured: up to approximately 20 months

  2. Overall response rate (ORR)

    Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) .

    Measured: up to 12 months

  3. Disease control rate (DCR)

    Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).

    Measured: up to 12 months

  4. Duration of response（DOR）

    For participants who demonstrate CR or PR, 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 12 months

  5. PFS rate of 6 months progression-free survival

    PFS rate of progression-free survival at 6 months: the percentage of subjects who did not develop disease progression or die of any cause at 6 months after beganing.

    Measured: up to 6 months

Timeline

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

  1. First posted24 Dec 2020
  2. Study start1 Apr 2021 (estimated)
  3. Primary completion30 Oct 2023 (estimated)
  4. Study completion30 Jun 2024 (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
69 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04683198
Sponsor's protocol ID
MA-SCLC-II-001
Status last verified
Oct 2020
First submitted
17 Dec 2020
Last updated
24 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing camrelizumab, Apatinib Mesylate and Carboplatin in people with Small-cell Lung Cancer, run by Chinese Academy of Medical Sciences.

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 8 inclusion and 17 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 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1 (time frame: Baseline until PD or death, whichever occurs first (up to approximately 13 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 NCT04683198.

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 24 Dec 2020; AzTrials last refreshed its copy on 8 Nov 2026.

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