Non-small Cell Lung CancerPhase 2/3NCT04968002
Application of Pablizumab Combined With Apatinib and Chemotherapy in Resectable Non-small Cell Lung Cancer： A Prospective, Single Arm, Single Center Phase II Clinical Study of Neoadjuvant Therapy
A Phase 2/3 study testing pablizumab combined with apatinib and neoadjuvant chemotherapy in people with Non-small Cell Lung Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This is a prospective, single arm, single center clinical study to determine the efficacy and safety of pablizumab combined with apatinib and neoadjuvant chemotherapy in patients with stage iia-iiia non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- pablizumab combined with apatinib and neoadjuvant chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 1 Oct 2022
- Phase
- Phase 2/3
- 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
- 2. Non small cell lung cancer was diagnosed by imaging, histopathology or cytology
- The resectable clinical stage assessed by the investigators was stage IIA - IIIA (according to AJCC)
- TNM staging, 8th Edition);
- 3. ECoG PS score: 0-1;
- 4. According to the RECIST version 1.1 evaluation standard, at least one image can be measured
- The lesions were measured;
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- 5. There was no operation contraindication in preoperative organ function examination;
- 6. The laboratory examination indexes meet the requirements:
- 7. No previous treatment for NSCLC, including surgery and chemotherapy
- Therapy, radiotherapy, targeted therapy, hormone or immunotherapy, etc;
- 8. Women of childbearing age agreed to use contraception during the study and within 6 months after the end of the study; study
- The serum or urine pregnancy test was negative in the first seven days, and the patients were not in lactation
- 9. The subjects can understand the research situation and sign the informed consent voluntarily.
- -
- Exclusion Criteria: 1. Have received any treatment including chemotherapy in the past
- Or radiotherapy;
- 2. The tumor has invaded important blood vessels or the tumor is in the treatment stage according to the judgment of the researcher
- There is a high possibility of invading important blood vessels and causing massive hemorrhage;
- 3. Known EGFR mutation or ALK gene translocation;
- 4. There are locally advanced unresectable diseases and metastatic diseases;
- 5. She had been suffering from the need to use corticosteroids (prednisolone) in 14 days before randomization
- Daily dose of nisone or equivalent (10 mg) or other immunosuppressive drugs
- Any disease requiring systemic treatment. Local replacement steroids are permitted
- (daily dose ≤ 10 mg of prednisone or equivalent) and prescription corticosteroids
- Short term (≤ 7 days) prophylactic use of alcohol or for the treatment of non autoimmune.
- Any active autoimmune disease or history of autoimmunity;
- 6. Active autoimmune diseases or autoimmune diseases that may recur
- History. Admission of well controlled type I diabetes and hormone replacement therapy are allowed.
- Hypothyroidism, well controlled celiac disease, and no need for complete treatment
- Skin diseases (such as vitiligo, psoriasis or alopecia) treated by the body or not
- Due to the absence of recurrence of the disease is not expected.
- 7. Interstitial lung disease, non infectious pneumonia or poorly controlled diseases (including pulmonary fibrosis)
- History of vitamin C, acute lung disease, etc.
- 8. active hepatitis B (defined as screening hepatitis B virus surface antigen [HBsAg])
- The results were positive and HBV-DNA was detected. The detection value was higher than that in the study
- Upper limit of normal value of cardiology laboratory) or hepatitis C (defined as screening hepatitis C virus table)
- The subjects with positive results of hcsab and HCV-RNA;
- 9. Known human immunodeficiency virus (HIV) infection (known HIV antibody positive);
- 10. Inoculate live vaccine within 30 days before the first administration. Including but not limited to the following:
- Mumps, rubella, measles, varicella / herpes zoster (varicella), yellow fever
- Rabies, BCG and typhoid vaccine (inactivated virus vaccine allowed);
- 11. Suffering from uncontrolled clinical symptoms or diseases of the heart;
- 12. Long term antiplatelet therapy is needed;
- 13. Those who are allergic to any drug in this program;
- 14. Pregnant or lactating women;
- 15. According to the judgment of the researcher, the subjects may confuse the test results and interfere
- It is not in the best interests of the subjects to participate in the whole trial
- A history or current evidence of any disease, treatment, or laboratory abnormality
- It's a good idea.
- 16. Active bleeding.
Who cannot join
- Ever received any treatment including chemotherapy or radiotherapy in the past;
- The tumor has invaded important blood vessels. There is a high possibility of invading important blood vessels and causing massive hemorrhage if the tumor is in the treatment stage process according to the judgment of the researcher;
- EGFR mutation or ALK gene translocation;
- There are locally advanced unresectable diseases and metastatic diseases;
- Patients had been suffering from the need to use corticosteroids (prednisolone) in 14 days before randomization grouping. Daily dose of nisone or equivalent (10 mg) or other immunosuppressive drugs. Any active autoimmune disease or history of autoimmunity;
- Active autoimmune diseases or autoimmune diseases that may recur
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- Interstitial lung disease, non infectious pneumonia or poorly controlled diseases (including pulmonary fibrosis) etc.
- active hepatitis B (defined as screening hepatitis B virus surface antigen [HBsAg]). And the results were positive and HBV-DNA was detected. The detection value was higher than that in the study upper limit of normal value of cardiology laboratory) or hepatitis C (defined as screening hepatitis C virus table and the subjects with positive results of hcsab and HCV-RNA;
- Known human immunodeficiency virus (HIV) infection (known HIV antibody positive);
- Inoculated live vaccine within 30 days before the first administration. Including but not limited to the following: Mumps, rubella, measles, varicella / herpes zoster (varicella), yellow fever Rabies, BCG and typhoid vaccine (inactivated virus vaccine allowed);
- Suffering from uncontrolled clinical symptoms or diseases of the heart;
- Long term antiplatelet therapy is needed;
- Those who are allergic to any drug in this program;
- Pregnant or lactating women.;
- According to the judgment of the researcher, the subjects may confuse and interfere the test results. It is not in the best interests of the subjects to participate in the whole trial.
- Active bleeding patients.
Trial locations and contacts
1 site in 1 country.
China1 site
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310000
Gang Shen, master, +86 571 87783641., 2198022@zju.edu.cn
About this study
This is a prospective, single arm, single center clinical study to determine the efficacy and safety of pablizumab combined with apatinib and neoadjuvant chemotherapy in patients with stage iia-iiia non-small cell lung cancer. No EGFR mutation or ALK gene translocation was found in the untreated patients with NSCLC stage IIa-IIIb diagnosed by imaging, histopathology or cytology. After informed consent is signed by the patients. The patients were treated according to the protocols. The patients were followed up from adjuvant treatment and follow-up to relapse free survival until disease progression, withdrawal of informed consent, loss of follow-up or death.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- pablizumab combined with apatinib and neoadjuvant chemotherapy
- Keywords
- non-small cell lung cancer, Pabolizumab
- 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.
pablizumab combined with apatinib and neoadjuvant chemotherapyDrug
The patients with stage IIa-IIIa non-small cell lung cancer are treated with pablizumab combined with apatinib and neoadjuvant chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Preoperative neoadjuvant therapy for patients with stage IIa-IIIa non-small cell lung cancer. | Experimental | No EGFR mutation or ALK gene translocation was found in the untreated patients with NSCLC stage IIa-IIIb diagnosed by imaging, histopathology or cytology. After informed consent is signed by the patients. The patients were treated according to the protocols. Receives: Drug: pablizumab combined with apatinib and neoadjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main pathological response rate
After neoadjuvant therapy, the residual tumor was observed under microscope with a result of the proportion of tumor cells was less than or equal to 10%.
Measured: through surgical treatment completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start1 Aug 2021 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968002
- Sponsor's protocol ID
- 2021-0309
- Status last verified
- Jun 2021
- First submitted
- 24 Jun 2021
- Last updated
- 20 Jul 2021
- 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 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Pablizumab Combined With Apatinib and Chemotherapy in Resectable Non-small Cell Lung Cancer： A Prospective, Single Arm, Single Center Phase II Clinical Study of Neoadjuvant Therapy
- ClinicalTrials.gov ID
- NCT04968002
- Acronym / sponsor ID
- 2021-0309
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- non-small cell lung cancer, Pabolizumab
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 20 Jul 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 prospective, single arm, single center clinical study to determine the efficacy and safety of pablizumab combined with apatinib and neoadjuvant chemotherapy in patients with stage iia-iiia non-small cell lung cancer. No EGFR mutation or ALK gene translocation was found in the untreated patients with NSCLC stage IIa-IIIb diagnosed by imaging, histopathology or cytology. After informed consent is signed by the patients. The patients were treated according to the protocols. The patients were followed up from adjuvant treatment and follow-up to relapse free survival until disease progression, withdrawal of informed consent, loss of follow-up or death.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative neoadjuvant therapy for patients with stage IIa-IIIa non-small cell lung cancer. | Experimental | Drug: pablizumab combined with apatinib and neoadjuvant chemotherapyNo EGFR mutation or ALK gene translocation was found in the untreated patients with NSCLC stage IIa-IIIb diagnosed by imaging, histopathology or cytology. After informed consent is signed by the patients. The patients were treated according to the protocols. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (50 listed)
- 2. Non small cell lung cancer was diagnosed by imaging, histopathology or cytology
- The resectable clinical stage assessed by the investigators was stage IIA - IIIA (according to AJCC)
- TNM staging, 8th Edition);
- 3. ECoG PS score: 0-1;
- 4. According to the RECIST version 1.1 evaluation standard, at least one image can be measured
Key exclusion criteria (16 listed)
- Ever received any treatment including chemotherapy or radiotherapy in the past;
- The tumor has invaded important blood vessels. There is a high possibility of invading important blood vessels and causing massive hemorrhage if the tumor is in the treatment stage process according to the judgment of the researcher;
- EGFR mutation or ALK gene translocation;
- There are locally advanced unresectable diseases and metastatic diseases;
- Patients had been suffering from the need to use corticosteroids (prednisolone) in 14 days before randomization grouping. Daily dose of nisone or equivalent (10 mg) or other immunosuppressive drugs. Any active autoimmune disease or history of autoimmunity;
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 |
|---|---|---|
| pablizumab combined with apatinib and neoadjuvant chemotherapyThe patients with stage IIa-IIIa non-small cell lung cancer are treated with pablizumab combined with apatinib and neoadjuvant chemotherapy | Drug | Preoperative neoadjuvant therapy for patients with stage IIa-IIIa non-small cell lung cancer. |
Primary outcome
The main pathological response rate
Time frame: through surgical treatment completion, an average of 4 months
After neoadjuvant therapy, the residual tumor was observed under microscope with a result of the proportion of tumor cells was less than or equal to 10%.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
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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 2/3 study testing pablizumab combined with apatinib and neoadjuvant chemotherapy in people with Non-small Cell Lung Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 50 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 20 Jul 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Gang Shen, master (+86 571 87783641., 2198022@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main pathological response rate (time frame: through surgical treatment completion, an average of 4 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 20 Jul 2021.