NSCLCPhase 2CAMFA-LNCT05005468
A Phase II Trial of Camrelizumab Combined With Famitinib for Adjuvant Treatment of Stage II-IIIA NSCLC.
A Phase 2 study testing Camrelizumab and Famitinib in people with NSCLC, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
This is a phase II, open-label, multi-cohort study, aiming to investigate safety and efficacy of Camrelizumab combined with famitinib for adjuvant treatment of stage II-IIIA non-small cell lung cancer with high-risk for relapse and no driver gene mutation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC
- What is being tested?
- Camrelizumab and Famitinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- Sep 2021to Aug 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old and ≤75 years old, both male and female;
- Standard surgical R0 resection and pathologically confirmed patients with stage II-IIIA (UICC/AJCC 7th edition lung cancer TNM staging) non-small cell lung cancer;
- ECOG PS score 0-1 points;
- EGFR, ALK gene wild type;
- The function of major organs is normal, the following standards are met: a) Routine blood examination (under 14 days without blood transfusion and no hematopoietic stimulating factor drugs for correction): hemoglobin (Hb) ≥90g/L; absolute neutrophil count (ANC) ≥1.5×10^9/L; platelet (PLT) ≥100×10^9/L; white blood cell count (WBC) ≥3.0×10^9/L; b) Biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN); serum total bilirubin (TBIL) ≤1.5×ULN; serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥50ml/min; c) coagulation function: activated partial coagulation activity Enzyme time (APTT), international normalized ratio (INR), prothrombin time (PT)≤1.5×ULN; d) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF)≥50%;
- The estimated survival time is at least 1 year;
- Women of childbearing age must undergo a negative pregnancy test (serum or urine) within 14 days before enrollment, and voluntarily use appropriate methods of contraception during the observation period and within 3 months after the last administration of the study drug; for men, it should be Surgical sterilization or consent to use appropriate methods of contraception during the observation period and within 3 months after the last administration of the study drug;
- The patient voluntarily participates and signs an informed consent form (or signed by a legal representative). It is expected to have good compliance and be able to cooperate with the research according to the requirements of the plan.
Who cannot join
- Have received neoadjuvant chemotherapy, radiotherapy or adjuvant radiotherapy;
- There is an unhealed wound or the risk of hemorrhage as judged by the investigator;
- Even after drug treatment, hypertension is still poorly controlled (continuous increase in systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg);
- Urine routine test indicates urine protein ≥(++), or 24-hour urine protein ≥1.0g;
- Abnormal blood coagulation function (INR>2.0, PT>16s), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy, and allow preventive use of low-dose aspirin and low molecular heparin;
- Patients at risk of gastrointestinal bleeding, including the following conditions: There are active peptic ulcer lesions and stool occult blood (++ ~ +++); Those who have a history of melena and hematemesis within 3 months; For fecal occult blood (+) or (+/-), it is necessary to review the stool routine within 1 week. Those who still (+) or (+/-) must undergo gastroscopy. If there is ulcer, bleeding disease, and The treating physician believes that there is a potential risk of bleeding;
Show all 18Show fewer
- Suffer from uncontrolled cardiac clinical symptoms or diseases, such as (1) NYHA II and above heart failure; (2) Unstable angina; (3) Myocardial infarction within 1 year; (4) Clinical significance Patients with supraventricular or ventricular arrhythmia requiring clinical intervention;
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis (hepatitis B, defined as hepatitis B virus surface antigen [HBsAg] test results are positive, HBV-DNA ≥ 500 IU/ml and abnormal liver function; hepatitis C is defined as hepatitis C antibody [HCV-Ab] positive, HCV-RNA higher than the detection limit of the analysis method and abnormal liver function) or combined hepatitis B and C co-infection ；
- Suffer from any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (hormone replacement) Can be included after treatment)); patients with childhood asthma that have been completely relieved and do not require any intervention or vitiligo after adulthood can be included, but patients who require medical intervention with bronchodilators cannot be included;
- Severe infection (such as intravenous infusion of antibiotics, antifungal or antiviral drugs required) within 2 weeks before the first administration, or unexplained fever >38.5°C during the screening period/before the first administration;
- Arterial/venous thrombosis events that occurred within 6 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.;
- Suffered from or accompanied with other systemic malignancies in the last 5 years, (except for cured skin basal cell carcinoma, cervical carcinoma in situ and ovarian cancer);
- Have received a preventive vaccine or attenuated vaccine within 4 weeks before the first administration;
- Those who are known to be allergic to any test drug or its excipients;
- Pregnant and lactating patients, and reproductive patients are unwilling to take effective contraceptive measures;
- Have a clear history of neurological or mental disorders, including epilepsy and dementia;
- Patients who cannot swallow the study drug, such as chronic diarrhea (including but not limited to irritable bowel syndrome, Crohn's disease, ulcerative colitis) and intestinal obstruction and other factors that affect drug intake and absorption;
- Other circumstances deemed inappropriate by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Trial of Camrelizumab Combined With Famitinib for Adjuvant Treatment of Stage II-IIIA Non-small Cell Lung Cancer With High-risk for Relapse and no Driver Gene Mutation.
This is a phase II, open-label, multi-cohort study, aiming to investigate safety and efficacy of Camrelizumab combined with famitinib for adjuvant treatment of stage II-IIIA non-small cell lung cancer with high-risk for relapse and no driver gene mutation.
Read the detailed description
Immunotherapy has shown good efficacy in advanced NSCLC. The IMpower010 study has found that immune adjuvant therapy after postoperative chemotherapy can significantly prolong disease-free survival. A number of basic and clinical studies have found that anti-vascular drugs can improve the tumor immune microenvironment, and the combination of anti-vascular and immunotherapy may further improve the efficacy. In this study, postoperative NSCLC with a high risk of recurrence was screened out through ctDNA detection, and received Camrelizumab combined with famitinib or observation to observe the efficacy and safety.
- Conditions
- NSCLC
- Being tested
- Camrelizumab, Famitinib
- Keywords
- NSCLC, II-IIIA
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 is given on the first day of each cycle, intravenous drip.
FamitinibDrug
Also called Famitinib Malate Capsules
Famitinib is administered orally, once a day.
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab Combined With Famitinib | Experimental | Drug: Camrelizumab Drug: Famitinib Receives: Drug: Camrelizumab; Drug: Famitinib |
| Observation | No intervention | Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS
Disease free survival
Measured: 6-18 months
Secondary outcomes (2)
OS
Overall survival
Measured: 30-48 months
DFS at 2/3/5years
DFS at 2/3/5years
Measured: 2-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study startSep 2021 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Shanghai Chest 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baohui Han, Shanghai Chest Hospital
- Investigators
- Baohui Han, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005468
- Sponsor's protocol ID
- NSCLC-ADJ-IIT-SHR1210-FMTN
- Acronym
- CAMFA-L
- Status last verified
- Aug 2021
- First submitted
- 5 Aug 2021
- Last updated
- 13 Aug 2021
- 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 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Camrelizumab Combined With Famitinib for Adjuvant Treatment of Stage II-IIIA Non-small Cell Lung Cancer With High-risk for Relapse and no Driver Gene Mutation.
- ClinicalTrials.gov ID
- NCT05005468
- Acronym / sponsor ID
- CAMFA-L / NSCLC-ADJ-IIT-SHR1210-FMTN
- Conditions
- NSCLC
- Keywords
- NSCLC, II-IIIA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 13 Aug 2021 (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.
This is a phase II, open-label, multi-cohort study, aiming to investigate safety and efficacy of Camrelizumab combined with famitinib for adjuvant treatment of stage II-IIIA non-small cell lung cancer with high-risk for relapse and no driver gene mutation.
Detailed description
Immunotherapy has shown good efficacy in advanced NSCLC. The IMpower010 study has found that immune adjuvant therapy after postoperative chemotherapy can significantly prolong disease-free survival. A number of basic and clinical studies have found that anti-vascular drugs can improve the tumor immune microenvironment, and the combination of anti-vascular and immunotherapy may further improve the efficacy. In this study, postoperative NSCLC with a high risk of recurrence was screened out through ctDNA detection, and received Camrelizumab combined with famitinib or observation to observe the efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab Combined With Famitinib | Experimental | Drug: Camrelizumab, Drug: FamitinibDrug: Camrelizumab Drug: Famitinib |
| Observation | No intervention | –Observation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years old and ≤75 years old, both male and female;
- Standard surgical R0 resection and pathologically confirmed patients with stage II-IIIA (UICC/AJCC 7th edition lung cancer TNM staging) non-small cell lung cancer;
- ECOG PS score 0-1 points;
- EGFR, ALK gene wild type;
- The function of major organs is normal, the following standards are met: a) Routine blood examination (under 14 days without blood transfusion and no hematopoietic stimulating factor drugs for correction): hemoglobin (Hb) ≥90g/L; absolute neutrophil count (ANC) ≥1.5×10^9/L; platelet (PLT) ≥100×10^9/L; white blood cell count (WBC) ≥3.0×10^9/L; b) Biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN); serum total bilirubin (TBIL) ≤1.5×ULN; serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥50ml/min; c) coagulation function: activated partial coagulation activity Enzyme time (APTT), international normalized ratio (INR), prothrombin time (PT)≤1.5×ULN; d) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF)≥50%;
Key exclusion criteria (18 listed)
- Have received neoadjuvant chemotherapy, radiotherapy or adjuvant radiotherapy;
- There is an unhealed wound or the risk of hemorrhage as judged by the investigator;
- Even after drug treatment, hypertension is still poorly controlled (continuous increase in systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg);
- Urine routine test indicates urine protein ≥(++), or 24-hour urine protein ≥1.0g;
- Abnormal blood coagulation function (INR>2.0, PT>16s), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy, and allow preventive use of low-dose aspirin and low molecular heparin;
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-1210Camrelizumab is given on the first day of each cycle, intravenous drip. | Drug | Camrelizumab Combined With Famitinib |
| FamitinibAlso: Famitinib Malate CapsulesFamitinib is administered orally, once a day. | Drug | Camrelizumab Combined With Famitinib |
Primary outcome
DFS
Time frame: 6-18 months
Disease free survival
2 secondary outcomes
OS
Time frame: 30-48 months
DFS at 2/3/5years
Time frame: 2-5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for NSCLC
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Baohui Han principal investigator
Shanghai Chest Hospital
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 Famitinib in people with NSCLC, run by Shanghai Chest 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 8 inclusion and 18 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 Aug 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 Baohui Han (18930858216, 18930858216@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFS (time frame: 6-18 months). 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 Aug 2021.