Advanced Non Squamous NSCLCPhase 2NCT04670913
Camrelizumab Plus Apatinib for Advanced Non-Squamous NSCLC Previously Treated With First-Line Immunotherapy
A Phase 2 study testing Camrelizumab and Apatinib in people with Advanced Non Squamous NSCLC, run by Junling Li at 1 site in China.
Trial summary
The purpose of this study is to assess the efficacy and safety of Camrelizumab plus Apatinib in the treatment of advanced non-squamous NSCLC previously treated with first-line immunotherapy Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Non Squamous NSCLC
- What is being tested?
- Camrelizumab and Apatinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2021to Jun 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed (infomed consent form, ICF).
- The best response of first-line immunotherapy was SD or above, and PFS was at least 3 months.
- Male and female aged ≥18 years and ≤75 years.
- Subjects with histologically or cytologically-documented non-squamous cell NSCLC who present with Stage IIIB/IV disease or recurrent or progressive disease following multimodal therapy.
- Patients who are unwilling to receive chemotherapy after disease recurrence or progression during/after first-line treatment including PD-(L)1 combined with chemotherapy, and PD-(L)1 monotherapy for advanced or metastatic disease.
- Measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria.
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- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Subjects are eligible if CNS metastases are asymptomatic or treated.
- Life expectancy ≥12 weeks.
- Fertile female must agree to use adequate contraception within 24 weeks from the beginning of the first dose of study medication to the last dose.
- Adequate organ and marrow function.
Who cannot join
- Prior treatment with anti-tumor virus, or prior T cell co-stimulation factors,including anti-Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibody or other T cell-targeted drugs.
- Subjects who had discontinued prior treatment due to immune-related adverse events (irAEs) or who are not suitable for PD-(L)1 treatment assessed by the investigator.
- Subjects with histologically or cytologically-documented squamous cell NSCLC.
- Prior treatments with anti-angiogenic agents.
- Subjects with activated EGFR gene mutation or ALK fusion mutation.
- Untreated or active central nervous system metastases (such as brain or meningeal metastases). Subjects are eligible if CNS metastases are asymptomatic or treated and subjects are off corticosteroids for at least 2 weeks prior to first dose of study therapy.
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- Radiotherapy for the chest and whole brain should be completed within 4 weeks before the first dose of study drug (palliative radiotherapy for bone lesions should be completed before the first dose of study drugs).
- History of active or recent history of known or suspected autoimmune disease.
- History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, radiation pneumonitis requiring steroid therapy, or evidence of active pneumonitis with clinical symptoms.
- History of active tuberculosis regardless of prior treatment.
- Malignancies other than NSCLC within 5 years prior to first administration of drugs, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome, such as cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and ductal carcinoma in situ after radical resection.
- Known mental illness, alcohol abuse, inability to quit smoking, drug or drug abuse, etc.
- Active hepatitis B or hepatitis C; History of known HIV-positive history or known AIDS.
- Treatment with any investigational agent within 28 days of signing ICF.
- According to the judgment of the investigator, subjects have other factors that may cause the study to be terminated halfway, such as non-compliance with the protocol, other serious diseases (including mental illness) requiring combined treatment, severe laboratory abnormalities, and Factors such as family or society will affect the safety of subjects or the collection of data and samples.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China
Beijing, Beijing Municipality, 100021
Junling Li, PhD, +861087788713, drlijunling@vip.163.com
Puyuan Xing, PhD, +861087788713, xingpuyuan@163.com
About this study
Official title: A Single-Arm Phase II Trial of Camrelizumab Plus Apatinib for Advanced Non-Squamous NSCLC Previously Treated With First-Line Immunotherapy
The purpose of this study is to assess the efficacy and safety of Camrelizumab plus Apatinib in the treatment of advanced non-squamous NSCLC previously treated with first-line immunotherapy
Read the detailed description
This trial will evaluate the safety and efficacy of Camrelizumab plus Apatinib in participants with advanced non-squamous NSCLC previously treated with first-line immunotherapy. The primary objective of this pilot study is to determine the Camrelizumab plus Apatinib improves progression-free survival (PFS) . All the efficacy and safety are assessed by investigator : 1) response rate (ORR), 2) duration of response(DoR), 3) overall survival(OS), 4) disease control rate (DCR); the safety and quality of life assessment Explore objective is potential biomarker associated with efficacy.
- Conditions
- Advanced Non Squamous NSCLC
- Being tested
- Camrelizumab, Apatinib
- Keywords
- programmed cell death 1 (PD-1, PD1), programmed cell death-ligand 1 (PD-L1, PDL1), anti-angiogenesis, First-Line Immunotherapy
- Medical subject headings
- Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
Also called SHR-1210
A human anti-PD-1 monoclonal antibody
ApatinibDrug
Also called Apatinibmesylate
A tyrosine kinase inhibitor selectively targeting VEGFR-2
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab plus Apatinib | Experimental | Camrelizumab, 200mg, q3w, iv and Apatinib, 250mg, qd, po Receives: Drug: Camrelizumab; Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
PFS is determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
Measured: up to 1 year
Secondary outcomes (7)
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: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 by investigator.
Measured: up to 1 year
Duration of Response
Duration of Response, determined using RECIST v1.1 criteria
Measured: up to 1 year
Disease Control Rate (DCR)
Disease Control Rate, determined using RECIST v1.1 criteria
Measured: up to 1 year
Overall Survival (OS)
Overall survival is the time interval from the date of randomization to death due to any reason or lost of follow-up
Measured: up to 2 years
Adverse Events (AEs) and Serious Adverse Events(SAEs)
The number of participants experiencing an AE and SAE will be assessed.Adverse
Measured: up to 1 year
QLQ-LC13
Quality of Life questionnaire lung cancer module 13
Measured: up to 1 years
EORTCQLQ-C30
European Organization for Reasearch and Treatment of Cancer C30
Measured: up to 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start28 Jun 2021
- Primary completionDec 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Non Squamous NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Junling Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Junling Li, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670913
- Sponsor's protocol ID
- NCC2607
- Status last verified
- Jun 2021
- First submitted
- 26 Nov 2020
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xing P, Wang M, Zhao J, Zhong W, Chi Y, Xu Z, Li J. Study protocol: A single-arm, multicenter, phase II trial of camrelizumab plus apatinib for advanced nonsquamous NSCLC previously treated with first-line immunotherapy. Thorac Cancer. 2021 Oct;12(20):2825-2828. doi: 10.1111/1759-7714.14113. Epub 2021 Aug 18.
PubMed 34409776
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Phase II Trial of Camrelizumab Plus Apatinib for Advanced Non-Squamous NSCLC Previously Treated With First-Line Immunotherapy
- ClinicalTrials.gov ID
- NCT04670913
- Acronym / sponsor ID
- NCC2607
- Conditions
- Advanced Non Squamous NSCLC
- Keywords
- programmed cell death 1 (PD-1, PD1), programmed cell death-ligand 1 (PD-L1, PDL1), anti-angiogenesis, First-Line Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Junling LiUniversity, hospital or other
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy and safety of Camrelizumab plus Apatinib in the treatment of advanced non-squamous NSCLC previously treated with first-line immunotherapy
Detailed description
This trial will evaluate the safety and efficacy of Camrelizumab plus Apatinib in participants with advanced non-squamous NSCLC previously treated with first-line immunotherapy. The primary objective of this pilot study is to determine the Camrelizumab plus Apatinib improves progression-free survival (PFS) . All the efficacy and safety are assessed by investigator : 1) response rate (ORR), 2) duration of response(DoR), 3) overall survival(OS), 4) disease control rate (DCR); the safety and quality of life assessment Explore objective is potential biomarker associated with efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab plus Apatinib | Experimental | Drug: Camrelizumab, Drug: ApatinibCamrelizumab, 200mg, q3w, iv and Apatinib, 250mg, qd, po |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Provision of signed (infomed consent form, ICF).
- The best response of first-line immunotherapy was SD or above, and PFS was at least 3 months.
- Male and female aged ≥18 years and ≤75 years.
- Subjects with histologically or cytologically-documented non-squamous cell NSCLC who present with Stage IIIB/IV disease or recurrent or progressive disease following multimodal therapy.
- Patients who are unwilling to receive chemotherapy after disease recurrence or progression during/after first-line treatment including PD-(L)1 combined with chemotherapy, and PD-(L)1 monotherapy for advanced or metastatic disease.
Key exclusion criteria (15 listed)
- Prior treatment with anti-tumor virus, or prior T cell co-stimulation factors,including anti-Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibody or other T cell-targeted drugs.
- Subjects who had discontinued prior treatment due to immune-related adverse events (irAEs) or who are not suitable for PD-(L)1 treatment assessed by the investigator.
- Subjects with histologically or cytologically-documented squamous cell NSCLC.
- Prior treatments with anti-angiogenic agents.
- Subjects with activated EGFR gene mutation or ALK fusion mutation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CamrelizumabAlso: SHR-1210A human anti-PD-1 monoclonal antibody | Drug | Camrelizumab plus Apatinib |
| ApatinibAlso: ApatinibmesylateA tyrosine kinase inhibitor selectively targeting VEGFR-2 | Drug | Camrelizumab plus Apatinib |
Primary outcome
Progression-free Survival (PFS)
Time frame: up to 1 year
PFS is determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
7 secondary outcomes
Objective response rate (ORR)
Time frame: up to 1 year
Duration of Response
Time frame: up to 1 year
Disease Control Rate (DCR)
Time frame: up to 1 year
Overall Survival (OS)
Time frame: up to 2 years
Adverse Events (AEs) and Serious Adverse Events(SAEs)
Time frame: up to 1 year
QLQ-LC13
Time frame: up to 1 years
EORTCQLQ-C30
Time frame: up to 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Derived from this study: PubMed 34409776Xing P, Wang M, Zhao J, Zhong W, Chi Y, Xu Z, Li J. Study protocol: A single-arm, multicenter, phase II trial of camrelizumab plus apatinib for advanced nonsquamous NSCLC previously treated with first-line immunotherapy. Thorac Cancer. 2021 Oct;12(20):2825-2828. doi: 10.1111/1759-7714.14113. Epub 2021 Aug 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camrelizumab and Apatinib in people with Advanced Non Squamous NSCLC, run by Junling Li 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 11 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: status not confirmed, as of the sponsor's last update on 29 Jun 2021. 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 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 Junling Li, PhD (86-010-87788713, drlijunling@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (time frame: up to 1 year). 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 NCT04670913, 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 29 Jun 2021.