Non Small Cell Lung CancerPhase 2NCT06467617
Adebrelimab Plus Chemo and Recaticimab in Perioperative Treatment of Resectable NSCLC
A Phase 2 study testing Adebrelimab plus albumin-bound paclitaxel, carboplatin and recaticimab in people with Non Small Cell Lung Cancer, run by Beijing Chest Hospital, Capital Medical University at 1 site in China.
Trial summary
Current studies confirmed that the immune perioperative treatment with combination chemotherapy curative effect and safety of resectable NSCLC, but its short-term curative effect and long-term survival benefit remains to be further improved to explore the new way of immune combination therapy. 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?
- Adebrelimab plus albumin-bound paclitaxel, carboplatin and recaticimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 14 Aug 2024to 1 Mar 2027
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years old, male and female;
- ECOG PS 0-1;
- Histologically or cytologically confirmed operable stage II-III NSCLC (stages II, IIIA, and T3N2M0 IIIB) according to the UICC and AJCC 8th edition TNM staging system. Non-massive metastases (short diameter ≤2cm Lymph nodes) with expected complete resectable N2;
- With a measurable lesions (per RECIST 1.1 standard, tumor lesions on CT scan length to diameter 10 mm, or lymph node lesions on CT scans short diameter 15 mm or higher);
- Anti-tumor treatment (radiotherapy, chemotherapy, surgery, and targeted therapy) naive enrollment;
- Enough of lung function to go through R0 resection with a purpose of cure;
- Normal main organs function, should meet the following criteria: (1) the blood routine examination shall meet within 14 days (without blood transfusion, hematopoietic factor not used and unused drugs to correct) a. ANC≥1.8 x 109 / L; B. Hb≥100 g/L; C. PLT ≥ 125×109/L; (2) Biochemical examination must meet the following criteria: a. TBIL ≤ 1.5ULN; B. ALT、AST≤2.5 ULN; Serum creatinine sCr≤1.5ULN, endogenous creatinine clearance≥50ml/min (Cockcroft-Gault formula)
Who cannot join
- Known EGFR or ALK mutation;
- T4 tumors invading the heart, great vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, tracheal carina, Upper sulcus lung cancer;
- Use of immunosuppressive drugs within 4 weeks before the first dose of study drug, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (i.e., ≤10 mg/day of prednisolone or other corticosteroids at physiological doses of equivalent drugs, with discontinuation of the drug for ≥1 week);
- Received immunoregulatory effects of herbal medicine or Immune regulating effect of drugs (including thymosin, interferon, interleukin, except for local control Pleural effusion use) within 4 weeks before the first use of the study drug;
- Malignant tumors other than NSCLC occurred within 5 years before enrollment.
- Administered Live attenuated vaccine ≤ 4 weeks before the first dose or will be planned for the duration of the study；
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- Current are participating in clinical research and treatment of intrusive, or within 4 weeks before the first delivery received study drugs or other treatments; Not fully recovered from any intervention-related toxicity and/or complications before the first dose (i.e., ≤ grade 1 or baseline, excluding fatigue or alopecia)；
- Severe infection (e.g., requiring intravenous antibiotics, antifungal or antiviral drugs) within 4 weeks before the first dose, or unexplained fever during screening/before the first dose. 38.5°C；
- Have or suspected a history of pneumonia/interstitial lung disease or any lung disease that would interfere with pulmonary function testing;
- With any active history of autoimmune disease or autoimmune diseases; Patients with complete remission of childhood asthma without any intervention in adulthood or with vitiligo were eligible;
- With congenital or acquired immune function defects, such as human immunodeficiency virus (HIV) infection, active hepatitis B, hepatitis C, hepatitis B and hepatitis C infection together and alcoholic liver cirrhosis patients;
- Patients with grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval ≥450ms in men and ≥470ms in women). According to NYHA standard, grade III ~ Ⅳ cardiac insufficiency, or heart colour to exceed examination prompt left ventricular ejection fraction (LVEF) < 50% into the group of the first six months happened myocardial infarction, heart failure, New York heart association class II or above has not been control angina pectoris, out of control of severe ventricular arrhythmia, with clinical significance of cardiac disease, Or abnormal electrocardiogram (ecg) indicate that acute ischemia or active conduction system;
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) more than 2 times the upper limit of normal value, or total bilirubin more than 1.5 times the upper limit of normal value (ULN); Creatine kinase (CK) was more than 3 times the upper limit of normal; There were major hemorrhagic events or arteriovenous thrombotic events
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Known allergy, hypersensitivity, or intolerance to the study drug or its excipients;
- Any condition considered by the investigator to be present that could 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. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Chest Hospital
Beijing, Beijing Municipality, 101125
Jinghui Wang, 13683128239, jinghuiwang2006@163.com
About this study
Official title: A Phase II Clinical Study of Adabrelimab Combined With Carboplatin, Albumin-bound Paclitaxel, and Recaticimab in Perioperative Treatment of Resectable NSCLC
Current studies confirmed that the immune perioperative treatment with combination chemotherapy curative effect and safety of resectable NSCLC, but its short-term curative effect and long-term survival benefit remains to be further improved to explore the new way of immune combination therapy.
Experimental study showed that the inhibition of PCSK9 could significantly increase in tumor cells of the immune response in mice, inhibit the PCSK9 enhanced anti-tumor immune response of mice can be further coordinate with immune checkpoint therapy, forming a lasting anti-tumor immune effect.
Read more
There are no reports on the peri-operative treatment of immune combined with chemotherapy and PCSK-9 inhibitors in patients with resectable NSCLC.
Based on the above, the aim of this study is to explore the efficacy and safety of Adebrelimab combined with recaticimab and chemotherapy in the perioperative treatment of patients with resectable NSCLC.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Adebrelimab plus albumin-bound paclitaxel, carboplatin and recaticimab
- 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.
Adebrelimab plus albumin-bound paclitaxel, carboplatin and recaticimabDrug
Adebrelimab (1200 mg,IV, D1, Q3W) +
albumin-bound paclitaxel (260 mg/m2, IV, divided by D1,8,Q3W) +
carboplatin (AUC 5mg/mL/min, IV, D1,Q3W) +
recaticimab (150 mg, SC, D1,Q3W)
21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Adebrelimab plus albumin-bound paclitaxel, carboplatin and recaticimab | Experimental | Participants will receive Adebrelimab 1200mg IV on Day 1 of a 21-Day cycle plus albumin-bound paclitaxel 260 mg/m2, IV, divided by D1,8 of a 21-Day cycle plus Carboplatin AUC 5mg/mL/min, IV, and recaticimab 150 mg, SC on the Day 1 of a 21-Day cycle Receives: Drug: Adebrelimab plus albumin-bound paclitaxel, carboplatin and recaticimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR
Pathological complete response；
Measured: 1.5 year
Secondary outcomes (4)
MPR
major pathologic response
Measured: through study completion, an average of 2 year
ORR
Objective response rate
Measured: through study completion, an average of 2 year
EFS
Event free survival
Measured: through study completion, an average of 2 year
DFS
Disease free survival
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start14 Aug 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Mar 2027 (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.
- 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chest Hospital, Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinghui Wang, Beijing Chest Hospital, Capital Medical University
- Investigators
- Jinghui Wang, Study chair, Director of Research Laboratory, Beijing Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467617
- Sponsor's protocol ID
- BJXK-2024-IIT-05
- Status last verified
- Dec 2024
- First submitted
- 13 Jun 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study of Adabrelimab Combined With Carboplatin, Albumin-bound Paclitaxel, and Recaticimab in Perioperative Treatment of Resectable NSCLC
- ClinicalTrials.gov ID
- NCT06467617
- Acronym / sponsor ID
- BJXK-2024-IIT-05
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Beijing Chest Hospital, Capital Medical UniversityUniversity, hospital or other
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 21 Jun 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.
Current studies confirmed that the immune perioperative treatment with combination chemotherapy curative effect and safety of resectable NSCLC, but its short-term curative effect and long-term survival benefit remains to be further improved to explore the new way of immune combination therapy.
Experimental study showed that the inhibition of PCSK9 could significantly increase in tumor cells of the immune response in mice, inhibit the PCSK9 enhanced anti-tumor immune response of mice can be further coordinate with immune checkpoint therapy, forming a lasting anti-tumor immune effect.
There are no reports on the peri-operative treatment of immune combined with chemotherapy and PCSK-9 inhibitors in patients with resectable NSCLC.
Based on the above, the aim of this study is to explore the efficacy and safety of Adebrelimab combined with recaticimab and chemotherapy in the perioperative treatment of patients with resectable NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adebrelimab plus albumin-bound paclitaxel, carboplatin and recaticimab | Experimental | Drug: Adebrelimab plus albumin-bound paclitaxel, carboplatin and recaticimabParticipants will receive Adebrelimab 1200mg IV on Day 1 of a 21-Day cycle plus albumin-bound paclitaxel 260 mg/m2, IV, divided by D1,8 of a 21-Day cycle plus Carboplatin AUC 5mg/mL/min, IV, and recaticimab 150 mg, SC on the Day 1 of a 21-Day cycle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18-75 years old, male and female;
- ECOG PS 0-1;
- Histologically or cytologically confirmed operable stage II-III NSCLC (stages II, IIIA, and T3N2M0 IIIB) according to the UICC and AJCC 8th edition TNM staging system. Non-massive metastases (short diameter ≤2cm Lymph nodes) with expected complete resectable N2;
- With a measurable lesions (per RECIST 1.1 standard, tumor lesions on CT scan length to diameter 10 mm, or lymph node lesions on CT scans short diameter 15 mm or higher);
- Anti-tumor treatment (radiotherapy, chemotherapy, surgery, and targeted therapy) naive enrollment;
Key exclusion criteria (16 listed)
- Known EGFR or ALK mutation;
- T4 tumors invading the heart, great vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, tracheal carina, Upper sulcus lung cancer;
- Use of immunosuppressive drugs within 4 weeks before the first dose of study drug, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (i.e., ≤10 mg/day of prednisolone or other corticosteroids at physiological doses of equivalent drugs, with discontinuation of the drug for ≥1 week);
- Received immunoregulatory effects of herbal medicine or Immune regulating effect of drugs (including thymosin, interferon, interleukin, except for local control Pleural effusion use) within 4 weeks before the first use of the study drug;
- Malignant tumors other than NSCLC occurred within 5 years before enrollment.
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 plus albumin-bound paclitaxel, carboplatin and recaticimabAdebrelimab (1200 mg,IV, D1, Q3W) + albumin-bound paclitaxel (260 mg/m2, IV, divided by D1,8,Q3W) + carboplatin (AUC 5mg/mL/min, IV, D1,Q3W) + recaticimab (150 mg, SC, D1,Q3W) 21-day cycle | Drug | Adebrelimab plus albumin-bound paclitaxel, carboplatin and recaticimab |
Primary outcome
pCR
Time frame: 1.5 year
Pathological complete response；
4 secondary outcomes
MPR
Time frame: through study completion, an average of 2 year
ORR
Time frame: through study completion, an average of 2 year
EFS
Time frame: through study completion, an average of 2 year
DFS
Time frame: through study completion, an average of 2 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 16 Dec 2024.
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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.
Jinghui Wang study chair
Director of Research Laboratory, Beijing 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 Adebrelimab plus albumin-bound paclitaxel, carboplatin and recaticimab in people with Non Small Cell Lung Cancer, run by Beijing Chest Hospital, Capital 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 7 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: looking for participants now, as of the sponsor's last update on 16 Dec 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?
Contact Jinghui Wang (13683128239, jinghuiwang2006@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR (time frame: 1.5 year). 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 16 Dec 2024.