Early Stage Non-small Cell Lung CancerPhase 2NCT04530227
Camrelizumab With Chemotherapy in Adults With Medically Inoperable Early Stage NSCLC
A Phase 2 study testing Biological: Camrelizumab, Pemetrexed and Nab-paclitaxel in people with Early Stage Non-small Cell Lung Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
The purpose of this study is to assess the efficacy and safety of Camrelizumab plus chemotherapy in the treatment of adult participants with medically inoperable Stage I or IIA non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Stage Non-small Cell Lung Cancer
- What is being tested?
- Biological: Camrelizumab, Pemetrexed and Nab-paclitaxel
- 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
- 25 Sep 2020to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥18 years, male and female are not limited;
- Patients with ECOG score of 0-1;
- Life expectancy ≥12 weeks;
- Patients must have histologically- or cytologically-documented NSCLC (according to 2015 WHO Classification);
- Patients with stage I - IIA (T1-T2bN0M0, tumor size ≤ 50mm) confirmed by radiographic；and medical inoperable, unable to undergo thoracic surgery, or refusing to surgery (according to the eighth edition of TNM staging);
- Patients with measurable target lesions according to the RECIST 1.1 standard;
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- Patients have not received prior treatment for their NSCLC, including radiotherapy, chemotherapy, surgery and target drugs;
- Can provide tumor tissue;
- Adequate organ and marrow function;
- Fertile female were required to have a serum or urine pregnancy test within 72 hours before the start dose of study medication and the result has been negative;If female of childbearing potential, is willing to use adequate contraception for the course of the study through 90 days after the last dose of study medication; if male with a female partner(s) of child-bearing potential, must agree to use adequate contraception starting with the first dose of study medication through 90 days after the last dose of study medication;
- Provision of signed ICF.
Who cannot join
- Known any distance metastases;
- Patients with known EGFR gene mutation or ALK fusion mutation;
- Patients with any active autoimmune disease or history of autoimmune disease;
- Patients with innate or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B, hepatitis C or co-infection with hepatitis B and hepatitis C;
- Subjects requiring systemic treatment with corticosteroids (> 10 mg / day of prednisone or its equivalent) or other immunosuppressants within 14 days prior to the first administration;
- Patient must not have received a live, attenuated vaccine within 4 weeks prior to the first administration;
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- Any therapy for NSCLC treatment;
- Patients with other malignant tumors in the past 5 years;
- Patients with previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiologic pneumonia, drug-induced pneumonia and active pneumonia confirmed by imaging;
- Patients with cardiac insufficiency;
- Routine urine test indicated that urine protein was >= (+ +), or 24-hour urine protein was >= 1g, or severe liver and kidney dysfunction;
- Patients with severe infection or fever of unknown origin >38.5 ℃ within 4 weeks prior to the first administration;
- Patients with known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Pregnant or lactating women; those with fertility who are unwilling or unable to take effective contraceptive measures;
- Known allergies, hypersensitivity, or intolerance to camrelizumab or its excipients or to pemetrexed or to nab-paclitaxel;
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of patient safety or study results，or the patient is unlikely to comply with study procedures, restrictions, and requirements.
Trial locations and contacts
1 site in 1 country.
Lianming Zhang, PhD contact
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, 300060
Changli Wang
About this study
Official title: A Pilot Study of Camrelizumab With Chemotherapy in Adults With Medically Inoperable Early Stage Non-Small Cell Lung Cancer (NSCLC)
The purpose of this study is to assess the efficacy and safety of Camrelizumab plus chemotherapy in the treatment of adult participants with medically inoperable Stage I or IIA non-small cell lung cancer (NSCLC).
Read the detailed description
This trial will evaluate the safety and efficacy of camrelizumab in combination with chemotherapy, followed by camrelizumab alone after 4-6 cycles of combination in participants with medically inoperable stage I or IIA non-small cell lung cancer (NSCLC). The primary objective of this pilot study is to determine the Camrelizumab plus chemotherapy improves progression-free survival (PFS) . All the efficacy and safety are assessed by investigator : 1) response rate (ORR), 2) disease control rate (DCR); 3) overall survival (OS), 4) PFS rate of 1-year, 2-year, and 5-year; and 5) OS rate of 1-year, 2-year, and 5-year.
Explore objective is potential biomarker associated with efficacy.
- Conditions
- Early Stage Non-small Cell Lung Cancer
- Being tested
- Biological: Camrelizumab, Pemetrexed, Nab-paclitaxel
- Keywords
- programmed cell death 1 (PD-1, PD1), programmed cell death-ligand 1 (PD-L1, PDL1)
- 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.
Biological: CamrelizumabDrug
Also called SHR-1210
PD-1
PemetrexedDrug
Also called Pemetrexed Disodium
chemotherapy
Nab-paclitaxelDrug
Also called Paclitaxel for Injection（Albumin Bound）
chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab combined with chemotherapy | Experimental | Participants receive camrelizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 18 cycles PLUS Investigator's choice of chemotherapy.
Interventions:
Biological: Camrelizumab Receives: Drug: Biological: Camrelizumab; Drug: Pemetrexed; Drug: Nab-paclitaxel |
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 approximately 3 years
Secondary outcomes (10)
Overall Survival (OS)
OS is defined as the first date of treatment to date of death from any causes.
Measured: up to approximately 5 years
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 approximately 1 years
Disease Control Rate (DCR)
DCR is defined as the percentage of patients who have achieved complete response and partial response per RECIST 1.1 by investigator..
Measured: up to approximately 3 years
Adverse Events (AEs)
The number of participants experiencing an AE will be assessed.
Measured: up to 18 months
PFS at 12 months (PFS12)
PFS will be calculated using Kaplan-Meier product limit methods.
Measured: up to maximum 12 months
PFS at 24 months (PFS24)
PFS will be calculated using Kaplan-Meier product limit methods.
Measured: up to maximum 24 months
PFS at 5 years
PFS will be calculated using Kaplan-Meier product limit methods.
Measured: up to maximum 5 years
OS at 12 months (OS12)
OS will be calculated using Kaplan-Meier product limit methods.
Measured: up to maximum 12 months
OS at 24 months (OS24)
OS will be calculated using Kaplan-Meier product limit methods.
Measured: up to maximum 24 months
OS at 5 years
OS will be calculated using Kaplan-Meier product limit methods.
Measured: up to maximum 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start25 Sep 2020
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Stage Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- 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
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530227
- Sponsor's protocol ID
- MA-NSCLC-II-007
- Status last verified
- Aug 2020
- First submitted
- 25 Aug 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Camrelizumab With Chemotherapy in Adults With Medically Inoperable Early Stage Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT04530227
- Acronym / sponsor ID
- MA-NSCLC-II-007
- Conditions
- Early Stage Non-small Cell Lung Cancer
- Keywords
- programmed cell death 1 (PD-1, PD1), programmed cell death-ligand 1 (PD-L1, PDL1)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Aug 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 chemotherapy in the treatment of adult participants with medically inoperable Stage I or IIA non-small cell lung cancer (NSCLC).
Detailed description
This trial will evaluate the safety and efficacy of camrelizumab in combination with chemotherapy, followed by camrelizumab alone after 4-6 cycles of combination in participants with medically inoperable stage I or IIA non-small cell lung cancer (NSCLC). The primary objective of this pilot study is to determine the Camrelizumab plus chemotherapy improves progression-free survival (PFS) . All the efficacy and safety are assessed by investigator : 1) response rate (ORR), 2) disease control rate (DCR); 3) overall survival (OS), 4) PFS rate of 1-year, 2-year, and 5-year; and 5) OS rate of 1-year, 2-year, and 5-year.
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 combined with chemotherapy | Experimental | Drug: Biological: Camrelizumab, Drug: Pemetrexed, Drug: Nab-paclitaxelParticipants receive camrelizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 18 cycles PLUS Investigator's choice of chemotherapy. Interventions: Biological: Camrelizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients aged ≥18 years, male and female are not limited;
- Patients with ECOG score of 0-1;
- Life expectancy ≥12 weeks;
- Patients must have histologically- or cytologically-documented NSCLC (according to 2015 WHO Classification);
- Patients with stage I - IIA (T1-T2bN0M0, tumor size ≤ 50mm) confirmed by radiographic；and medical inoperable, unable to undergo thoracic surgery, or refusing to surgery (according to the eighth edition of TNM staging);
Key exclusion criteria (16 listed)
- Known any distance metastases;
- Patients with known EGFR gene mutation or ALK fusion mutation;
- Patients with any active autoimmune disease or history of autoimmune disease;
- Patients with innate or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B, hepatitis C or co-infection with hepatitis B and hepatitis C;
- Subjects requiring systemic treatment with corticosteroids (> 10 mg / day of prednisone or its equivalent) or other immunosuppressants within 14 days prior to the first administration;
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 |
|---|---|---|
| Biological: CamrelizumabAlso: SHR-1210PD-1 | Drug | Camrelizumab combined with chemotherapy |
| PemetrexedAlso: Pemetrexed Disodiumchemotherapy | Drug | Camrelizumab combined with chemotherapy |
| Nab-paclitaxelAlso: Paclitaxel for Injection（Albumin Bound）chemotherapy | Drug | Camrelizumab combined with chemotherapy |
Primary outcome
Progression-free Survival (PFS)
Time frame: up to approximately 3 years
PFS is determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
10 secondary outcomes
Overall Survival (OS)
Time frame: up to approximately 5 years
Objective response rate (ORR)
Time frame: up to approximately 1 years
Disease Control Rate (DCR)
Time frame: up to approximately 3 years
Adverse Events (AEs)
Time frame: up to 18 months
PFS at 12 months (PFS12)
Time frame: up to maximum 12 months
PFS at 24 months (PFS24)
Time frame: up to maximum 24 months
PFS at 5 years
Time frame: up to maximum 5 years
OS at 12 months (OS12)
Time frame: up to maximum 12 months
OS at 24 months (OS24)
Time frame: up to maximum 24 months
OS at 5 years
Time frame: up to maximum 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
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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.
Lianming Zhang, PhD contact
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 Biological: Camrelizumab, Pemetrexed and Nab-paclitaxel in people with Early Stage Non-small Cell Lung Cancer, run by Tianjin Medical University Cancer Institute and Hospital 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 16 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 13 Nov 2020. 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 Changli Wang, PhD (86-22-23340123 ext. 6417, wangchangli@medmail.com.cn), 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 approximately 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2020.