Non Small Cell Lung CancerPhase 2NCT06424899
A Study Comparing Neoadjuvant Chemoimmunotherapy and Immuno-consolidationafter Compared With Immunoconsolidation After Radical Chemoradiotherapy for Stage III Potentially Resectable NSCLC
A Phase 2 study testing Adebrelimab, radical chemoradiotherapy and Platinum based chemotherapy in people with Non Small Cell Lung Cancer, run by Zeng Jian at 1 site in China.
Trial summary
To evaluate the efficacy and safety adebrelimab in Combination with chemotherapy after 3 cycles as neoadjuvant therapy and surgery or chemoradiotherapy based on MDT compared with adebrelimab after chemoradiotherapy in potentially operable stage III NSCLC. 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, radical chemoradiotherapy and Platinum based chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 19 May 2024to 31 Dec 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
- 1. Age 18-75 years old;
- 2. Histologically or cytologically confirmed non-small cell lung cancer. If the pathological type of the patient is adenocarcinoma, genetic testing should be performed to exclude EGFR/ALK mutations. Tumor tissue should be the first choice for genetic testing. If sufficient tumor tissue is not available, genetic testing using serum can be performed.
- 3. According to AJCC 8th Edition, the patient had stage IIIA-IIIB (T1-4N2M0). N2 was a non-giant type with lymph node diameter ≤3cm and no invasion or exocapsular invasion. Pathological biopsy of mediastinal lymph nodes is recommended to be clear, and patients without pathology should at least meet the short diameter of enhanced chest CT ≥1cm and high metabolism of PET-CT.
- 4. All lesions (including primary lesions and lymph nodes/metastases evaluated as metastases) of the patient should be evaluated jointly by surgeons, radiologists, and radiologists to be potentially resectable.
- 5. Subjects must have measurable target lesions (according to RECIST 1.1 criteria);
- 6. ECOG behavior status score 0-1;
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- 7. No previous history of other malignant tumors;
- 8. Never received anti-tumor therapy such as surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy related to non-small cell lung cancer;
- 9. The patient should have adequate cardiopulmonary function: FEV1 and DLCO of the patient were ≥50% of the predicted value, and the ultrasonography suggested LVEF≥55%, and no clear signs of heart failure and severe coronary artery stenosis were found in various tests. The cardiopulmonary function was assessed by the surgeon as being able to tolerate surgical treatment.
- 10.The functional level of all vital organs must meet the following requirements:
- Bone marrow: absolute neutrophil count (ANC) ≥1.5× 109/L, platelet ≥100 × 109/L, hemoglobin ≥9 g /dl;
- Good coagulation function: defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN;
- Liver: total bilirubin ≤1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5 times the upper limit of normal;
- Kidney: serum creatinine ≤1.25 times the upper limit of normal or creatinine clearance (calculated by Cockcroft-Gault formula) ≥60 ml/min;
- 11. Fertile men and women of childbearing age must consent to effective contraceptive use from the time they sign the master informed consent until 180 days after the final administration of the study drug. Women of reproductive age include premenopausal women and women within 2 years after menopause. Pregnancy test results of women of reproductive age must be negative within ≤ 7 days before the first study drug administration;
- 12. Voluntary participation in clinical research; Fully understand and know this study and sign ICF (Informed Consent).
Who cannot join
- 1. All lesions could not be completely resected by surgery;
- 2. Have any active autoimmune disease or history of autoimmune disease (such as uveitis, enteritis, hepatitis, pituitaritis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (may be included after hormone replacement therapy), tuberculosis); Patients with complete remission of childhood asthma without any intervention or vitiligo in adulthood could be included, but patients requiring medical intervention with bronchodilators could not be included;
- 3. Have a congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (HCV antibody positive and HCV-RNA above the lower detection limit of analytical methods), or co-infection with hepatitis B and hepatitis C;
- 4. There is a third lacunar effusion that is difficult to control, such as a large amount of pleural effusion or ascites or pericardial effusion;
- 5. Subjects requiring systemic therapy with corticosteroids (>10 mg/ day of prednisone or equivalent) or other immunosuppressants within 14 days prior to initial medication. In the absence of active autoimmune disease, inhaled or topical corticosteroids are permitted, as well as adrenal hormone replacement therapy at doses > 10 mg/ day of prednisone efficacy;
- 6. Subjects who have been treated with anti-tumor vaccine or other immunostimulating anti-tumor drugs (interferon, interleukin, thymosin, immunocell therapy, etc.) within 1 month before the first administration;
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- 7. Participants who are participating in another clinical study or whose first dose is less than 4 weeks (or 5 half-lives of the investigational drug) since the end (last dose) of the previous clinical study;
- 8. Evidence of past or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiological pneumonia, drug-induced pneumonia, and severe impairment of lung function;
- 9. Major surgery, open biopsy, or significant trauma were performed within 28 days prior to enrollment;
- 10. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- 11. Pregnant or lactating women; A fertile patient who is unwilling or unable to take effective contraceptive measures;
- 12. Known allergic reactions, hypersensitivities, or intolerances to study drugs;
- 13. There are other circumstances in which the investigator considers it inappropriate to participate in 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
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Jian Zeng, Doctor, +86 13675870286, luotaobo@163.com
About this study
Official title: A Randomized, Controlled, Multicenter Phase II Clinical Study Comparing Neoadjuvant Chemoimmunotherapy and Immuno-consolidationafter Compared With Immunoconsolidation After Radical Chemoradiotherapy for Stage III Potentially Resectable NSCLC
To evaluate the efficacy and safety adebrelimab in Combination with chemotherapy after 3 cycles as neoadjuvant therapy and surgery or chemoradiotherapy based on MDT compared with adebrelimab after chemoradiotherapy in potentially operable stage III NSCLC.
Read the detailed description
In recent years, tumor immunotherapy has become an important means of clinical treatment of tumor. The emergence of immunotherapy has provided a new direction for the exploration of neoadjuvant therapy for non-small cell lung cancer. The purpose of this study is to compare the use of adebrelimab in patients with stage III potentially resectable locally advanced NSCLC (non-small cell lung cancer). The study will directly compare the curative chemoradiotherapy plus immune maintenance therapy model (Pacific model) with the neoadjuvant immune therapy plus curative surgery plus immune maintenance therapy model (Keynote-671 model). This comparison aims to provide a basis for determining treatment plans for patients with locally advanced NSCLC.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Adebrelimab, radical chemoradiotherapy, Platinum based chemotherapy
- 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.
AdebrelimabDrug
Also called SHR-1316
This product is administered by intravenously guttae. The recommended dose of subcutaneous injection is 20mg/kg, administered every 3 Weeks (Q3W).
radical chemoradiotherapyRadiation
The total dose of radiotherapy was 60 Gy ± 10% (54 Gy - 66 Gy). The minimum technical standard for radiotherapy is the three dimensional conformal radiotherapy (3D-CRT) planned by CT.
Platinum based chemotherapyDrug
Platinum based chemotherapy: Platinum drug must be one of cisplatin, carboplatin or nedaplatin; The other drug must contain one of the following: etoposide, vinorelbine, vinblastine, pemetrexed, taxanes (e.g., paclitaxel, docetaxel, albumin paclitaxel, paclitaxel liposomes) or gemcitabine (gemcitabine is not permitted in concurrent chemoradiotherapy regimens).
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant: adebrelimab combined with platinum-based chemotherapy | Experimental | Adebrelimab 20mg/kg combined with platinum-based chemotherapy, q3w, MDT after 3 cycles, if the patient is suitable for surgery, surgery will be performed, and Adebrelimab adjuvant therapy will be performed for 35 cycles after surgery or until the disease recurrence or toxicity is difficult to tolerate as indicated by imaging; If the patient is not eligible for surgery after evaluation,, radical chemoradiotherapy will be performed, followed by Adebrelimab consolidation therapy for 35 cycles or until radiographically indicated disease recurrence or toxicity is difficult to tolerate. Receives: Drug: Adebrelimab; Radiation: radical chemoradiotherapy; Drug: Platinum based chemotherapy |
| radical chemoradiotherapy and adebrelimab consolidation for 38 cycles | Active comparator | Consolidation therapy with adebrelimab , 20mg/kg, q3w, d1, was started within 1 to 42 days after radical chemoradiotherapy. The infusion time of adebrelimab was 60 minutes or more, and the treatment lasted for 38 consecutive cycles or until the disease recurred or the toxic reaction was difficult to tolerate as indicated by imaging. Receives: Drug: Adebrelimab; Radiation: radical chemoradiotherapy; Drug: Platinum based chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 year EFS rate
From the start of randomization to 2 years, the proportion of participants who experience any of the following events: disease progression making surgical treatment impossible, local or distant recurrence, or death due to any cause.
Event-free Survival (EFS) is a term commonly used in the context of clinical trials and oncology to describe a period during which a patient with a disease, typically a cancer, remains free from any adverse events that are of clinical significance.
Measured: Up to 2 years
Secondary outcomes (3)
OS
Overall Survival, the time from the date of randomization until the death of the participant or the last follow-up.
Measured: Up to 2 years
TTDM
the time from the initial diagnosis of a cancer until the first occurrence of distant metastasis.
Measured: Up to 2 years
TRAEs
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v5.0
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start19 May 2024 (estimated)
- Primary completion19 May 2027 (estimated)
- Study completion31 Dec 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeng Jian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeng Jian, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424899
- Sponsor's protocol ID
- IRB-2024-106
- Status last verified
- May 2024
- First submitted
- 10 May 2024
- Last updated
- 22 May 2024
- 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 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Multicenter Phase II Clinical Study Comparing Neoadjuvant Chemoimmunotherapy and Immuno-consolidationafter Compared With Immunoconsolidation After Radical Chemoradiotherapy for Stage III Potentially Resectable NSCLC
- ClinicalTrials.gov ID
- NCT06424899
- Acronym / sponsor ID
- IRB-2024-106
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Zeng JianUniversity, hospital or other
- Study start
- 19 May 2024 (estimated)
- Primary completion
- 19 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 May 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.
To evaluate the efficacy and safety adebrelimab in Combination with chemotherapy after 3 cycles as neoadjuvant therapy and surgery or chemoradiotherapy based on MDT compared with adebrelimab after chemoradiotherapy in potentially operable stage III NSCLC.
Detailed description
In recent years, tumor immunotherapy has become an important means of clinical treatment of tumor. The emergence of immunotherapy has provided a new direction for the exploration of neoadjuvant therapy for non-small cell lung cancer. The purpose of this study is to compare the use of adebrelimab in patients with stage III potentially resectable locally advanced NSCLC (non-small cell lung cancer). The study will directly compare the curative chemoradiotherapy plus immune maintenance therapy model (Pacific model) with the neoadjuvant immune therapy plus curative surgery plus immune maintenance therapy model (Keynote-671 model). This comparison aims to provide a basis for determining treatment plans for patients with locally advanced NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant: adebrelimab combined with platinum-based chemotherapy | Experimental | Drug: Adebrelimab, Radiation: radical chemoradiotherapy, Drug: Platinum based chemotherapyAdebrelimab 20mg/kg combined with platinum-based chemotherapy, q3w, MDT after 3 cycles, if the patient is suitable for surgery, surgery will be performed, and Adebrelimab adjuvant therapy will be performed for 35 cycles after surgery or until the disease recurrence or toxicity is difficult to tolerate as indicated by imaging; If the patient is not eligible for surgery after evaluation,, radical chemoradiotherapy will be performed, followed by Adebrelimab consolidation therapy for 35 cycles or until radiographically indicated disease recurrence or toxicity is difficult to tolerate. |
| radical chemoradiotherapy and adebrelimab consolidation for 38 cycles | Active comparator | Drug: Adebrelimab, Radiation: radical chemoradiotherapy, Drug: Platinum based chemotherapyConsolidation therapy with adebrelimab , 20mg/kg, q3w, d1, was started within 1 to 42 days after radical chemoradiotherapy. The infusion time of adebrelimab was 60 minutes or more, and the treatment lasted for 38 consecutive cycles or until the disease recurred or the toxic reaction was difficult to tolerate as indicated by imaging. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 1. Age 18-75 years old;
- 2. Histologically or cytologically confirmed non-small cell lung cancer. If the pathological type of the patient is adenocarcinoma, genetic testing should be performed to exclude EGFR/ALK mutations. Tumor tissue should be the first choice for genetic testing. If sufficient tumor tissue is not available, genetic testing using serum can be performed.
- 3. According to AJCC 8th Edition, the patient had stage IIIA-IIIB (T1-4N2M0). N2 was a non-giant type with lymph node diameter ≤3cm and no invasion or exocapsular invasion. Pathological biopsy of mediastinal lymph nodes is recommended to be clear, and patients without pathology should at least meet the short diameter of enhanced chest CT ≥1cm and high metabolism of PET-CT.
- 4. All lesions (including primary lesions and lymph nodes/metastases evaluated as metastases) of the patient should be evaluated jointly by surgeons, radiologists, and radiologists to be potentially resectable.
- 5. Subjects must have measurable target lesions (according to RECIST 1.1 criteria);
Key exclusion criteria (13 listed)
- 1. All lesions could not be completely resected by surgery;
- 2. Have any active autoimmune disease or history of autoimmune disease (such as uveitis, enteritis, hepatitis, pituitaritis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (may be included after hormone replacement therapy), tuberculosis); Patients with complete remission of childhood asthma without any intervention or vitiligo in adulthood could be included, but patients requiring medical intervention with bronchodilators could not be included;
- 3. Have a congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (HCV antibody positive and HCV-RNA above the lower detection limit of analytical methods), or co-infection with hepatitis B and hepatitis C;
- 4. There is a third lacunar effusion that is difficult to control, such as a large amount of pleural effusion or ascites or pericardial effusion;
- 5. Subjects requiring systemic therapy with corticosteroids (>10 mg/ day of prednisone or equivalent) or other immunosuppressants within 14 days prior to initial medication. In the absence of active autoimmune disease, inhaled or topical corticosteroids are permitted, as well as adrenal hormone replacement therapy at doses > 10 mg/ day of prednisone efficacy;
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 |
|---|---|---|
| AdebrelimabAlso: SHR-1316This product is administered by intravenously guttae. The recommended dose of subcutaneous injection is 20mg/kg, administered every 3 Weeks (Q3W). | Drug | neoadjuvant: adebrelimab combined with platinum-based chemotherapy, radical chemoradiotherapy and adebrelimab consolidation for 38 cycles |
| radical chemoradiotherapyThe total dose of radiotherapy was 60 Gy ± 10% (54 Gy - 66 Gy). The minimum technical standard for radiotherapy is the three dimensional conformal radiotherapy (3D-CRT) planned by CT. | Radiation | neoadjuvant: adebrelimab combined with platinum-based chemotherapy, radical chemoradiotherapy and adebrelimab consolidation for 38 cycles |
| Platinum based chemotherapyPlatinum based chemotherapy: Platinum drug must be one of cisplatin, carboplatin or nedaplatin; The other drug must contain one of the following: etoposide, vinorelbine, vinblastine, pemetrexed, taxanes (e.g., paclitaxel, docetaxel, albumin paclitaxel, paclitaxel liposomes) or gemcitabine (gemcitabine is not permitted in concurrent chemoradiotherapy regimens). | Drug | neoadjuvant: adebrelimab combined with platinum-based chemotherapy, radical chemoradiotherapy and adebrelimab consolidation for 38 cycles |
Primary outcome
2 year EFS rate
Time frame: Up to 2 years
From the start of randomization to 2 years, the proportion of participants who experience any of the following events: disease progression making surgical treatment impossible, local or distant recurrence, or death due to any cause. Event-free Survival (EFS) is a term commonly used in the context of clinical trials and oncology to describe a period during which a patient with a disease, typically a cancer, remains free from any adverse events that are of clinical significance.
3 secondary outcomes
OS
Time frame: Up to 2 years
TTDM
Time frame: Up to 2 years
TRAEs
Time frame: Up to 2 years
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 May 2024.
- 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 Adebrelimab, radical chemoradiotherapy and Platinum based chemotherapy in people with Non Small Cell Lung Cancer, run by Zeng Jian 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 16 inclusion and 13 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 22 May 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 Jian Zeng, MD&PhD (+86 571 8812 8161, hzzengjian123@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2 year EFS rate (time frame: Up to 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 22 May 2024.