ImmunotherapyPhase 2PANORAMANCT05825443
Adjuvant Chemotherapy Combined With Camrelizumab for ⅡA -ⅢA NSCLC Patients
A Phase 2 study testing Camrelizumab in people with Immunotherapy and Chemotherapy, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Postoperative adjuvant chemotherapy followed by immunotherapy for non-small cell lung cancer has become a new treatment recommendation, but there are still many clinical problems to be solved in postoperative adjuvant immunotherapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Immunotherapy, Chemotherapy
- What is being tested?
- Camrelizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2023to 1 Apr 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign the informed consent form before starting the study;
- For patients with non-small cell lung cancer who have undergone surgical resection, the TNM stage after surgery is IIA-IIIA;
- Patients cannot receive targeted adjuvant therapy;
- 18-80 years old;
- The patient can recover within 3-8 weeks after the operation, and receive postoperative adjuvant treatment;
- The ECOG PS score is 0 or 1;
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- Have not received any chemotherapy for non-small cell lung cancer before enrollment;
- Within 7 days before enrollment, the laboratory inspection must meet all the following requirements:
- Absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, hemoglobin ≥ 9g/dL;
- Total bilirubin ≤ 1.5 ULN; AST and ALT ≤ 2.5 ULN;
- Serum creatinine ≤ 1.25 ULN, or serum creatinine clearance ≥ 60ml/min;
- Female patients must meet: menopause or have undergone surgical sterilization. Women with fertility must take effective contraceptive measures. Do not breastfeed.
- Male patients must agree to use appropriate contraceptive measures.
Who cannot join
- Known or suspected to be allergic to the drug or any component of the drug related to the test;
- Patients who can receive targeted treatment;
- Other malignant tumors in five years before enrollment, excluding the cured cervical carcinoma in situ, the cured skin basal cell carcinoma, and other types of tumors that were cured only after surgical treatment;
- Myocardial infarction, unstable angina pectoris and grade II congestive heart failure in six months before enrollment; New angina pectoris occurred within 3 months; Ventricular arrhythmia requiring medication;
- Uncontrolled hypertension after treatment with antihypertensive drugs, i.e. systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg;
- History of HIV infection, active period of HCV infection, active period of HBV infection (HBV-DNA>1000 copies/ml);
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- The researcher judged that there was a risk of bleeding;
- Active severe clinical infection (≥ grade 3 CTCAE V5.0);
- Epilepsy patients who need medication;
- Allogeneic organ transplantation;
- Patients who need kidney dialysis;
- Thrombotic or embolic venous or arterial events occurred within six months before enrollment;
- Serious uncured wounds, ulcers or fractures;
- Interstitial pneumonia;
- Any malabsorption disease;
- Any disease that is unstable or may endanger the patient's safety;
- Drug abuse, medical, psychological or social diseases;
- Participate in other clinical studies within 3 months before enrollment;
- During pregnancy or lactation;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guandong, Guangdong, 510515
Di Lu, MD, PhD, 86+13268379321, david_lu189@163.com
About this study
Official title: Efficacy and Safety of Postoperative Adjuvant Chemotherapy Combined With Camrelizumab for Patients With ⅡA -ⅢA Non-small Cell Lung Cancer：a Phase II , Single-arm Clinical Study
Postoperative adjuvant chemotherapy followed by immunotherapy for non-small cell lung cancer has become a new treatment recommendation, but there are still many clinical problems to be solved in postoperative adjuvant immunotherapy. This study aims to explore the efficacy and safety of adjuvant chemotherapy combined with immunotherapy in patients with stage IIA-IIIA non-small cell lung cancer after surgery. Patients who meet the protocol and sign the informed consent form received 4 cycles of chemotherapy combined with camrelizumab, followed by maintenance with camrelizumab until one year or the disease progressed or unacceptable toxicity.
- Conditions
- Immunotherapy, Chemotherapy
- Being tested
- Camrelizumab
- Keywords
- Camrelizumab, Non-small Cell Lung Cancer, Adjuvant therapy
- 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 Cisplatin, carboplatin, pemetrexed, paclitaxel liposome
Patients received four 21-day cycles of chemotherapy (decided by the researcher) combined with camrelizumab (200 mg in day 1), followed by maintenance with camrelizumab (200 mg in day 1, q3w), until one year or the disease progressed or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Patients who meet the protocol and sign the informed consent form received 4 cycles of chemotherapy combined with camrelizumab, followed by maintenance with camrelizumab until one year or the disease progressed or unacceptable toxicity. The chemotherapy regimen is decided by the researcher. Receives: Drug: Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-years disease free survival (2y-DFS)
DFS, defined as the time from first dose of Camrelizumab to the first occurrence of disease recurrence as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. According to the K-M curve, the proportion of disease-free progression in 2 years.
Measured: Up to approximately 2 years
Secondary outcomes (8)
Three-years disease free survival (3y-DFS)
According to the K-M curve, the proportion of disease-free progression in 3 years
Measured: Up to approximately 3 years
Five-years disease free survival (5y-DFS)
According to the K-M curve, the proportion of disease-free progression in 5 years
Measured: Up to approximately 5 years
Disease free survival (DFS）
DFS, defined as the time from first dose of Camrelizumab to the first occurrence of disease recurrence as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first.
Measured: Up to approximately 2 years
Overall survival (OS)
Defined as the time from randomization to death from any cause.
Measured: Up to approximately 5 years
Two-years overall survival（2y-OS)
According to the K-M curve, the proportion of OS in 2 years
Measured: Up to approximately 2 years
Three-years overall survival（3y-OS)
According to the K-M curve, the proportion of OS in 3 years
Measured: Up to approximately 3 years
Five-years overall survival（5y-OS)
According to the K-M curve, the proportion of OS in 5 years
Measured: Up to approximately 5 years
Treatment-related adverse events（TRAE）
The incidence of TRAE and the incidence of level 3-4 TRAE according to CTCAE v5.0
Measured: Up to approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start10 Apr 2023
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunotherapyStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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
- Model description
- Four cycles of chemotherapy combine with camrelizumab, followed by maintenance with camrelizumab until one year or the disease progressed or unacceptable toxicity
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825443
- Sponsor's protocol ID
- NFEC-2023-031
- Acronym
- PANORAMA
- Status last verified
- Apr 2023
- First submitted
- 2 Mar 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Postoperative Adjuvant Chemotherapy Combined With Camrelizumab for Patients With ⅡA -ⅢA Non-small Cell Lung Cancer：a Phase II , Single-arm Clinical Study
- ClinicalTrials.gov ID
- NCT05825443
- Acronym / sponsor ID
- PANORAMA / NFEC-2023-031
- Conditions
- Immunotherapy, Chemotherapy
- Keywords
- Camrelizumab, Non-small Cell Lung Cancer, Adjuvant therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 24 Apr 2023 (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.
Postoperative adjuvant chemotherapy followed by immunotherapy for non-small cell lung cancer has become a new treatment recommendation, but there are still many clinical problems to be solved in postoperative adjuvant immunotherapy. This study aims to explore the efficacy and safety of adjuvant chemotherapy combined with immunotherapy in patients with stage IIA-IIIA non-small cell lung cancer after surgery. Patients who meet the protocol and sign the informed consent form received 4 cycles of chemotherapy combined with camrelizumab, followed by maintenance with camrelizumab until one year or the disease progressed or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Four cycles of chemotherapy combine with camrelizumab, followed by maintenance with camrelizumab until one year or the disease progressed or unacceptable toxicity
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: CamrelizumabPatients who meet the protocol and sign the informed consent form received 4 cycles of chemotherapy combined with camrelizumab, followed by maintenance with camrelizumab until one year or the disease progressed or unacceptable toxicity. The chemotherapy regimen is decided by the researcher. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Sign the informed consent form before starting the study;
- For patients with non-small cell lung cancer who have undergone surgical resection, the TNM stage after surgery is IIA-IIIA;
- Patients cannot receive targeted adjuvant therapy;
- 18-80 years old;
- The patient can recover within 3-8 weeks after the operation, and receive postoperative adjuvant treatment;
Key exclusion criteria (19 listed)
- Known or suspected to be allergic to the drug or any component of the drug related to the test;
- Patients who can receive targeted treatment;
- Other malignant tumors in five years before enrollment, excluding the cured cervical carcinoma in situ, the cured skin basal cell carcinoma, and other types of tumors that were cured only after surgical treatment;
- Myocardial infarction, unstable angina pectoris and grade II congestive heart failure in six months before enrollment; New angina pectoris occurred within 3 months; Ventricular arrhythmia requiring medication;
- Uncontrolled hypertension after treatment with antihypertensive drugs, i.e. systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg;
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: Cisplatin, carboplatin, pemetrexed, paclitaxel liposomePatients received four 21-day cycles of chemotherapy (decided by the researcher) combined with camrelizumab (200 mg in day 1), followed by maintenance with camrelizumab (200 mg in day 1, q3w), until one year or the disease progressed or unacceptable toxicity. | Drug | Treatment group |
Primary outcome
Two-years disease free survival (2y-DFS)
Time frame: Up to approximately 2 years
DFS, defined as the time from first dose of Camrelizumab to the first occurrence of disease recurrence as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. According to the K-M curve, the proportion of disease-free progression in 2 years.
8 secondary outcomes
Three-years disease free survival (3y-DFS)
Time frame: Up to approximately 3 years
Five-years disease free survival (5y-DFS)
Time frame: Up to approximately 5 years
Disease free survival (DFS）
Time frame: Up to approximately 2 years
Overall survival (OS)
Time frame: Up to approximately 5 years
Two-years overall survival（2y-OS)
Time frame: Up to approximately 2 years
Three-years overall survival（3y-OS)
Time frame: Up to approximately 3 years
Five-years overall survival（5y-OS)
Time frame: Up to approximately 5 years
Treatment-related adverse events（TRAE）
Time frame: Up to approximately 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- 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.
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 in people with Immunotherapy and Chemotherapy, run by Nanfang Hospital, Southern Medical University 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 13 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 25 Apr 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Di Lu (020-62787240, david_lu1989@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two-years disease free survival (2y-DFS) (time frame: Up to approximately 2 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 25 Apr 2023.