Unresectable Locally Advanced Non-small Cell Lung CancerPhase 2NCT06700421
Phase II Clinical Study of Adebrelimab Combined with Apatinib in the Treatment of Locally Advanced Non-small Cell Lung Cancer Patients with Radiation Pneumonitis
A Phase 2 study testing Adebrelimab + Apatinib in people with Unresectable Locally Advanced Non-small Cell Lung Cancer, run by Wei Zhou at 1 site in China.
Trial summary
A prospective, single-center, phase II clinical study of adebrelimab combined with apatinib in the treatment of unresectable stage III NSCLC patients with grade ≤2 radiation pneumonitis after definitive chemoradiotherapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Locally Advanced Non-small Cell Lung Cancer
- What is being tested?
- Adebrelimab + Apatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 13 Aug 2024to 31 Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old, male or female;
- ECOG PS score 0-1;
- The expected survival time is not less than 12 weeks;
- Histologically or cytologically confirmed non-small cell lung cancer patients with unresectable locally advanced (stage III) (AJCC TNM staging, 8th edition);
- Patients who are not candidates for EGFR, ALK, or ROS1 targeted therapy, as confirmed by histologic or cytologic specimens (with documented evidence of no EGFR sensitizing mutation, ALK gene rearrangement, or ROS1 gene fusion);
- Patients with grade 2 or below radiation pneumonitis without disease progression after receiving platinum-based concurrent/sequential chemoradiotherapy;
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- First dose was administered on days 1-42 (up to 42 days) after completion of concurrent/sequential platinum-based chemoradiotherapy for grade ≤1 RP; Patients with grade 2 RP who were downgraded to less than grade 1 RP within 56 days (including 56 days) after concurrent/sequential chemoradiotherapy received the first medication, and consolidation chemotherapy after radiotherapy was not allowed during the period.
- All toxic effects from previous antineoplastic therapy, except hearing loss, alopecia, and fatigue, had to have recovered to grade 1 or less (according to NCI CTCAE V5.0) or baseline levels to be eligible.
- 9. Have not received any anti-CTLA-4, anti-PD-1, anti-PD-L1/2, anti-angiogenesis inhibitors, or anti-tumor vaccine therapy; 10. Provide or collect biopsy tissue or blood samples during the treatment for biomarker analysis according to the subjects' wishes; 11. Normal function of major organs and bone marrow; 12. Female subjects of childbearing potential had to have a negative serum or urine pregnancy test 72 hours before starting the trial and be willing to use a highly effective, medically approved contraceptive method for the duration of the study and for 90 days after the last dose of the trial drug; Male participants whose partner was a woman of childbearing potential agreed to use an effective method of contraception or to be surgically sterilized for the duration of the study and for 90 days after the last dose of the trial drug.
- 13. The subjects voluntarily participated in this study, and signed the informed consent form. The compliance was good, and the efficacy and adverse reactions were followed up according to the protocol.
Who cannot join
- Histological types of mixed small cell lung cancer and non-small cell lung cancer;
- Disease progression after chemoradiotherapy; Had undergone major surgery within 28 days before the first dose of a study drug or was planned to undergo major surgery during the study (at the investigator's discretion); 3.
- 4. Administration of live attenuated vaccine within 28 days prior to dose or planned for the duration of the study; 5. Participated in another clinical study within 28 days before the first use of a trial drug, and used any trial drug; 6. Grade ≥3 radiation pneumonitis caused by chemoradiotherapy; 7. Imaging (CT/MRI) showed that the tumor invaded the large blood vessels or had unclear boundaries with blood vessels; 8. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 9. Presence of any active autoimmune disease or a history of autoimmune disease with expected recurrence; 10. Congenital or acquired immune deficiency; 11. Suffering from an infectious disease that is poorly controlled; 12. Subjects requiring systemic treatment with corticosteroids (>10mg/ day of prednisone or equivalent dose of the same hormone) or other immunosuppressive agents within 14 days before the first dose of the trial drug; 13. Cancer other than NSCLC in the past 5 years; 14. Evidence of past or current severe impairment of lung function, with forced expiratory volume in 1 second (FEV1) <1.2L or DLCO<50% of predicted value; 15. Grade II or above myocardial ischemia or myocardial infarction with poorly controlled arrhythmia; 16. Have poorly controlled hypertension; 17. Occurrence of arterial/venous thrombotic events (cerebral embolism, deep vein thrombosis, pulmonary embolism, etc.) within 6 months before the first dose; 18. Subjects with clinically significant bleeding symptoms or clear evidence or history of bleeding tendency within 3 months before the first dose; 19. Obvious hemoptysis symptoms within 30 days before the first dose or hemoptysis of 2.5mL or more per day; 20. Known hereditary or acquired bleeding and thrombophilia (e.g. hemophilia, coagulopathy, thrombocytopenia, hypersplenism, etc.); 21. Urine routine showed urine protein ≥ (++), or 24-hour urine protein ≥ 1.0g; 22. The need for systemic antibiotics due to infection within 14 days before the first dose of medication; Or unexplained fever > 38.5 ° C 14 days before the first dose of medication; 23. Pregnant or lactating women; 24. Known allergy or intolerance to the study drug or its excipients; 25. Any condition that the investigator considers may harm the subject or cause the subject to be unable to meet or perform the requirements of the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality
About this study
Official title: A Prospective, Single-center, Phase II Clinical Study of Adebrelimab Combined with Apatinib in the Treatment of Unresectable Stage III NSCLC Patients with Grade ≤2 Radiation Pneumonitis After Definitive Chemoradiotherapy
A prospective, single-center, phase II clinical study of adebrelimab combined with apatinib in the treatment of unresectable stage III NSCLC patients with grade ≤2 radiation pneumonitis after definitive chemoradiotherapy
Read the detailed description
A prospective, single-center, phase II clinical study of adebrelimab combined with apatinib in the treatment of unresectable stage III NSCLC patients with grade ≤2 radiation pneumonitis after definitive chemoradiotherapy.At least 32 participants will be enrolled in this study.
- Being tested
- Adebrelimab + Apatinib
- Keywords
- Unresectable locally advanced non-small cell lung cancer, Radiation pneumonitis, Adebrelimab, Apatinib, Chemoradiotherapy
- Medical subject headings
- Radiation Pneumonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab + ApatinibDrug
Also called immunotherapy, Programmed death ligand 1 inhibitor, Antiangiogenic agents
Adebrelimab combined with apatinib
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | Patients with grade 0-1 radiation pneumonitis were enrolled and treated with adebrelimab combined with apatinib within 42 days after definitive chemoradiotherapy Receives: Drug: Adebrelimab + Apatinib |
| Group B | Other | Patients with grade 2 radiation pneumonitis were enrolled and treated with adebrelimab combined with apatinib within 56 days after definitive chemoradiotherapy Receives: Drug: Adebrelimab + Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Refers to the time from the start of nonrandomization until tumor progression or death from any cause, whichever occurs first
Measured: Doses were administered every 6 weeks from the first dose of study drug until approximately 12 months
Secondary outcomes (4)
overall survival, OS
Refers to the time from the start of nonrandomization until death from any cause.
Measured: Doses were administered every 6 weeks from the first dose of study drug until approximately 12 months
Objective Response Rate, ORR
Refers to the proportion of patients who have achieved a pre-defined tumor volume reduction (CR/PR) and maintained the minimum time frame required by the accepted response evaluation criteria (such as solid tumor RECIST Version 1.1).
Measured: Doses were administered every 6 weeks from the first dose of study drug until approximately 12 months
Disease control rate, DCR
Proportion of all subjects whose best overall response (BOR) was rated as complete response (CR), partial response (PR), and stable disease (SD) according to RECIST v1.1 criteria.
Measured: Doses were administered every 6 weeks from the first dose of study drug until approximately 12 months
Duration of response, DOR
Defined as the period from the date the tumor remission was first recorded to the date the disease progression was first recorded or the date of death from any cause
Measured: Doses were administered every 6 weeks from the first dose of study drug until approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start13 Aug 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Locally Advanced Non-small Cell Lung CancerStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei Zhou, Chongqing University Cancer Hospital
- Investigators
- Wei Zhou, Principal investigator, Chongqing University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700421
- Sponsor's protocol ID
- MA-NSCLC-II-035
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The survival data of individual participant will be shared after the research iscompleted.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Phase II Clinical Study of Adebrelimab Combined with Apatinib in the Treatment of Unresectable Stage III NSCLC Patients with Grade ≤2 Radiation Pneumonitis After Definitive Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT06700421
- Acronym / sponsor ID
- MA-NSCLC-II-035
- Keywords
- Unresectable locally advanced non-small cell lung cancer, Radiation pneumonitis, Adebrelimab, Apatinib, Chemoradiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Wei ZhouUniversity, hospital or other
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Nov 2024 (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.
A prospective, single-center, phase II clinical study of adebrelimab combined with apatinib in the treatment of unresectable stage III NSCLC patients with grade ≤2 radiation pneumonitis after definitive chemoradiotherapy
Detailed description
A prospective, single-center, phase II clinical study of adebrelimab combined with apatinib in the treatment of unresectable stage III NSCLC patients with grade ≤2 radiation pneumonitis after definitive chemoradiotherapy.At least 32 participants will be enrolled in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Drug: Adebrelimab + ApatinibPatients with grade 0-1 radiation pneumonitis were enrolled and treated with adebrelimab combined with apatinib within 42 days after definitive chemoradiotherapy |
| Group B | Other | Drug: Adebrelimab + ApatinibPatients with grade 2 radiation pneumonitis were enrolled and treated with adebrelimab combined with apatinib within 56 days after definitive chemoradiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years old, male or female;
- ECOG PS score 0-1;
- The expected survival time is not less than 12 weeks;
- Histologically or cytologically confirmed non-small cell lung cancer patients with unresectable locally advanced (stage III) (AJCC TNM staging, 8th edition);
- Patients who are not candidates for EGFR, ALK, or ROS1 targeted therapy, as confirmed by histologic or cytologic specimens (with documented evidence of no EGFR sensitizing mutation, ALK gene rearrangement, or ROS1 gene fusion);
Key exclusion criteria (3 listed)
- Histological types of mixed small cell lung cancer and non-small cell lung cancer;
- Disease progression after chemoradiotherapy; Had undergone major surgery within 28 days before the first dose of a study drug or was planned to undergo major surgery during the study (at the investigator's discretion); 3.
- 4. Administration of live attenuated vaccine within 28 days prior to dose or planned for the duration of the study; 5. Participated in another clinical study within 28 days before the first use of a trial drug, and used any trial drug; 6. Grade ≥3 radiation pneumonitis caused by chemoradiotherapy; 7. Imaging (CT/MRI) showed that the tumor invaded the large blood vessels or had unclear boundaries with blood vessels; 8. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 9. Presence of any active autoimmune disease or a history of autoimmune disease with expected recurrence; 10. Congenital or acquired immune deficiency; 11. Suffering from an infectious disease that is poorly controlled; 12. Subjects requiring systemic treatment with corticosteroids (>10mg/ day of prednisone or equivalent dose of the same hormone) or other immunosuppressive agents within 14 days before the first dose of the trial drug; 13. Cancer other than NSCLC in the past 5 years; 14. Evidence of past or current severe impairment of lung function, with forced expiratory volume in 1 second (FEV1) <1.2L or DLCO<50% of predicted value; 15. Grade II or above myocardial ischemia or myocardial infarction with poorly controlled arrhythmia; 16. Have poorly controlled hypertension; 17. Occurrence of arterial/venous thrombotic events (cerebral embolism, deep vein thrombosis, pulmonary embolism, etc.) within 6 months before the first dose; 18. Subjects with clinically significant bleeding symptoms or clear evidence or history of bleeding tendency within 3 months before the first dose; 19. Obvious hemoptysis symptoms within 30 days before the first dose or hemoptysis of 2.5mL or more per day; 20. Known hereditary or acquired bleeding and thrombophilia (e.g. hemophilia, coagulopathy, thrombocytopenia, hypersplenism, etc.); 21. Urine routine showed urine protein ≥ (++), or 24-hour urine protein ≥ 1.0g; 22. The need for systemic antibiotics due to infection within 14 days before the first dose of medication; Or unexplained fever > 38.5 ° C 14 days before the first dose of medication; 23. Pregnant or lactating women; 24. Known allergy or intolerance to the study drug or its excipients; 25. Any condition that the investigator considers may harm the subject or cause the subject to be unable to meet or perform the requirements of the study.
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 |
|---|---|---|
| Adebrelimab + ApatinibAlso: immunotherapy, Programmed death ligand 1 inhibitor, Antiangiogenic agentsAdebrelimab combined with apatinib | Drug | Group A, Group B |
Primary outcome
Progression free survival (PFS)
Time frame: Doses were administered every 6 weeks from the first dose of study drug until approximately 12 months
Refers to the time from the start of nonrandomization until tumor progression or death from any cause, whichever occurs first
4 secondary outcomes
overall survival, OS
Time frame: Doses were administered every 6 weeks from the first dose of study drug until approximately 12 months
Objective Response Rate, ORR
Time frame: Doses were administered every 6 weeks from the first dose of study drug until approximately 12 months
Disease control rate, DCR
Time frame: Doses were administered every 6 weeks from the first dose of study drug until approximately 12 months
Duration of response, DOR
Time frame: Doses were administered every 6 weeks from the first dose of study drug until approximately 12 months
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 22 Nov 2024.
- Individual participant dataSharing planned: Yes. The survival data of individual participant will be shared after the research iscompleted.
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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.
Wei Zhou principal investigator
Chongqing University Cancer 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 Adebrelimab + Apatinib in people with Unresectable Locally Advanced Non-small Cell Lung Cancer, run by Wei Zhou 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 10 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 22 Nov 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: Doses were administered every 6 weeks from the first dose of study drug until approximately 12 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 22 Nov 2024.