IMMUNOTHERAPYPhase 2NCT06241807
Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB NSCLC
A Phase 2 study testing Camrelizumab Plus Chemotherapy in people with IMMUNOTHERAPY and Neoadjuvant Therapy, run by Shandong Cancer Hospital and Institute at 1 site in China.
Trial summary
This study aims to evaluate the efficacy and safety of neoadjuvant camrelizumab combined with chemotherapy in resectable stage IIIA and IIIB (T3-4N2) non-small cell lung cancer (NSCLC) patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- IMMUNOTHERAPY, Neoadjuvant Therapy, Resectable Lung Non-Small Cell Carcinoma
- What is being tested?
- Camrelizumab Plus Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 2 Dec 2022to 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75
- Pathologically confirmed resectable stage IIIA-IIIB (T3-4N2) NSCLC
- Absence of EGFR, ALK, and ROS1 gene mutations
- Eastern Cooperative Oncology Group (ECOG) status 0-1
- Signed written informed consent prior to the implementation of any trial-related rocedures
- Adequate organ function, evidenced by laboratory results with no contraindications to chemotherapy: Absolute neutrophil count ≥ 1,500 х109/L, Thrombocytes ≥ 100 х 109/L, Hemoglobin ≥ 90 mg/L, Creatinine ≤ 1.5 x ULN or creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 40 mL/min, Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 2.5 x upper limit of normal (ULN), Alkaline phosphatase (ALP) \> 5 x ULN, Bilirubin \> 1.5 х ULN
Who cannot join
- Patients diagnosed with any other malignant tumor
- Have received prior therapy with chemotherapy or immune checkpoint inhibitor
- Insufficient caloric and/or fluid intake despite consultation with a dietitian and/or tube feeding
- Have an active infection requiring systemic therapy that has not resolved 3 days (simple infection, such as cystitis) to 7 days (severe infection, such as pyelonephritis) before the first dose of trial treatment
- Patients who cannot tolerate chemoradiotherapy or surgery due to severe cardiac, lung dysfunction
- A history of interstitial lung disease or non-infectious pneumonia
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- Active autoimmune disease with systemic therapy (ie, use of disease modifiers, corticosteroids, or immunosuppressive drugs) in the past 2 years
- Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibody) and various viral hepatitis infections
- Patients who have received allogeneic stem cell or solid organ transplantation
- Women during pregnancy or lactation
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
Shandong Cancer Hospital and Institute
Jinan, Shandong, 250117
Xue Meng, MD, PhD, +86-17653115602, mengxue5409@163.com
Guoxin Cai, MD, +33-751440039, Guoxin.CAI@gustaveroussy.fr
About this study
Official title: A Phase II Trial of Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB Non-Small Cell Lung Cancer
This study aims to evaluate the efficacy and safety of neoadjuvant camrelizumab combined with chemotherapy in resectable stage IIIA and IIIB (T3-4N2) non-small cell lung cancer (NSCLC) patients. Inclusion criteria are: age 18-75, pathologically confirmed resectable stage IIIA-IIIB (T3-4N2) NSCLC, absence of EGFR, ALK, and ROS1 gene mutations, and Eastern Cooperative Oncology Group (ECOG) status 0-1. All patients receive three cycles of camrelizumab combined with platinum-based doublet chemotherapy, followed by curative surgery within 4-6 weeks after completion of chemotherapy. Patients undergo 18F-fluorodeoxyglucose (FDG) PET/CT scans in 1 week before treatment and 1 week before surgery, and peripheral blood samples are collected for biomarker analysis. The primary endpoints for follow-up are pathologic complete response (pCR) rate and major pathological response (MPR) rate, while secondary endpoints include safety and progression-free survival. Exploratory endpoints include molecular imaging research and biomarker analysis.
- Conditions
- IMMUNOTHERAPY, Neoadjuvant Therapy, Resectable Lung Non-Small Cell Carcinoma, Biomarkers / Blood
- Being tested
- Camrelizumab Plus Chemotherapy
- Keywords
- Camrelizumab, Non-Small Cell Lung Cancer, Neoadjuvant Therapy, Biomarkers Analysis
- 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.
Camrelizumab Plus ChemotherapyDrug
Patients were assigned to receive 3 cycles of camrelizumab (200 mg) plus chemotherapy (nab-paclitaxel, 130 mg/m2 or pemetrexed (for adenocarcinoma), 500mg/m2 plus platinum [cisplatin, 75 mg/m2; carboplatin, area under the curve, 5])
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab Plus Chemotherapy Arm | Experimental | Patients were assigned to receive 3 cycles of camrelizumab (200 mg) plus chemotherapy (nab-paclitaxel, 130 mg/m2 or pemetrexed (for adenocarcinoma), 500mg/m2 plus platinum [cisplatin, 75 mg/m2; carboplatin, area under the curve, 5]) Receives: Drug: Camrelizumab Plus Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathological Response Rate
No more than 10% of tumor cells were found in neoadjuvant surgical specimens
Measured: From date of surgery to 14 days later
Pathologic complete response rate
No histological evidence of malignancy was found in the primary tumor and metastatic lymph nodes
Measured: From date of surgery to 14 days later
Secondary outcomes (2)
Adverse events
Number and percentage of cases of all adverse events
Measured: 24 weeks
Disease-free survival
The period of time from the initiation of treatment to the observation of disease progression or occurrence of death for any reason
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start2 Dec 2022
- 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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for IMMUNOTHERAPYStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xue Meng, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241807
- Sponsor's protocol ID
- SDZL-MX-01
- Status last verified
- Feb 2024
- First submitted
- 28 Jan 2024
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cai G, Song P, Wang Z, Zhao J, Wang K, Li M, Wang X, Zhu J, Xu J, Huang B, Han X, Zhou H, Xie C, Fu S, Jia H, Teng F, Wang S, Sun H, Li W, Yu J, Meng X. Neoadjuvant camrelizumab plus chemotherapy in resectable stage IIIA-IIIB non-small cell lung cancer: integrated multidimensional biomarker analysis from a phase II study. J Immunother Cancer. 2026 Jun 19;14(6):e015604. doi: 10.1136/jitc-2026-015604.
PubMed 42320986Wang K, Wang X, Meng X, Zhang G, Cai G. Molecular imaging using 18F-FDG PET/CT and circulating inflammatory and immune indicators to predict pathological response to neoadjuvant camrelizumab plus chemotherapy in resectable stage IIIA-IIIB NSCLC. Ann Nucl Med. 2025 Aug;39(8):862-874. doi: 10.1007/s12149-025-02057-0. Epub 2025 May 10.
PubMed 40348946
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06241807
- Acronym / sponsor ID
- SDZL-MX-01
- Conditions
- IMMUNOTHERAPY, Neoadjuvant Therapy, Resectable Lung Non-Small Cell Carcinoma, Biomarkers / Blood
- Keywords
- Camrelizumab, Non-Small Cell Lung Cancer, Neoadjuvant Therapy, Biomarkers Analysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Feb 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.
This study aims to evaluate the efficacy and safety of neoadjuvant camrelizumab combined with chemotherapy in resectable stage IIIA and IIIB (T3-4N2) non-small cell lung cancer (NSCLC) patients. Inclusion criteria are: age 18-75, pathologically confirmed resectable stage IIIA-IIIB (T3-4N2) NSCLC, absence of EGFR, ALK, and ROS1 gene mutations, and Eastern Cooperative Oncology Group (ECOG) status 0-1. All patients receive three cycles of camrelizumab combined with platinum-based doublet chemotherapy, followed by curative surgery within 4-6 weeks after completion of chemotherapy. Patients undergo 18F-fluorodeoxyglucose (FDG) PET/CT scans in 1 week before treatment and 1 week before surgery, and peripheral blood samples are collected for biomarker analysis. The primary endpoints for follow-up are pathologic complete response (pCR) rate and major pathological response (MPR) rate, while secondary endpoints include safety and progression-free survival. Exploratory endpoints include molecular imaging research and biomarker analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab Plus Chemotherapy Arm | Experimental | Drug: Camrelizumab Plus ChemotherapyPatients were assigned to receive 3 cycles of camrelizumab (200 mg) plus chemotherapy (nab-paclitaxel, 130 mg/m2 or pemetrexed (for adenocarcinoma), 500mg/m2 plus platinum [cisplatin, 75 mg/m2; carboplatin, area under the curve, 5]) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-75
- Pathologically confirmed resectable stage IIIA-IIIB (T3-4N2) NSCLC
- Absence of EGFR, ALK, and ROS1 gene mutations
- Eastern Cooperative Oncology Group (ECOG) status 0-1
- Signed written informed consent prior to the implementation of any trial-related rocedures
Key exclusion criteria (10 listed)
- Patients diagnosed with any other malignant tumor
- Have received prior therapy with chemotherapy or immune checkpoint inhibitor
- Insufficient caloric and/or fluid intake despite consultation with a dietitian and/or tube feeding
- Have an active infection requiring systemic therapy that has not resolved 3 days (simple infection, such as cystitis) to 7 days (severe infection, such as pyelonephritis) before the first dose of trial treatment
- Patients who cannot tolerate chemoradiotherapy or surgery due to severe cardiac, lung dysfunction
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 |
|---|---|---|
| Camrelizumab Plus ChemotherapyPatients were assigned to receive 3 cycles of camrelizumab (200 mg) plus chemotherapy (nab-paclitaxel, 130 mg/m2 or pemetrexed (for adenocarcinoma), 500mg/m2 plus platinum [cisplatin, 75 mg/m2; carboplatin, area under the curve, 5]) | Drug | Camrelizumab Plus Chemotherapy Arm |
Primary outcome
Major Pathological Response Rate
Time frame: From date of surgery to 14 days later
No more than 10% of tumor cells were found in neoadjuvant surgical specimens
Pathologic complete response rate
Time frame: From date of surgery to 14 days later
No histological evidence of malignancy was found in the primary tumor and metastatic lymph nodes
2 secondary outcomes
Adverse events
Time frame: 24 weeks
Disease-free survival
Time frame: 24 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 14 Feb 2024.
- Derived from this study: PubMed 42320986Cai G, Song P, Wang Z, Zhao J, Wang K, Li M, Wang X, Zhu J, Xu J, Huang B, Han X, Zhou H, Xie C, Fu S, Jia H, Teng F, Wang S, Sun H, Li W, Yu J, Meng X. Neoadjuvant camrelizumab plus chemotherapy in resectable stage IIIA-IIIB non-small cell lung cancer: integrated multidimensional biomarker analysis from a phase II study. J Immunother Cancer. 2026 Jun 19;14(6):e015604. doi: 10.1136/jitc-2026-015604.
- Derived from this study: PubMed 40348946Wang K, Wang X, Meng X, Zhang G, Cai G. Molecular imaging using 18F-FDG PET/CT and circulating inflammatory and immune indicators to predict pathological response to neoadjuvant camrelizumab plus chemotherapy in resectable stage IIIA-IIIB NSCLC. Ann Nucl Med. 2025 Aug;39(8):862-874. doi: 10.1007/s12149-025-02057-0. Epub 2025 May 10.
- Individual participant dataSharing planned: Undecided
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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 Camrelizumab Plus Chemotherapy in people with IMMUNOTHERAPY and Neoadjuvant Therapy, run by Shandong Cancer Hospital and Institute 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 6 inclusion and 10 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 14 Feb 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 Xue Meng, MD, PhD (+86-17653115602, mengxue5409@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathological Response Rate (time frame: From date of surgery to 14 days later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06241807, which also lists 2 linked publications.
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 14 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.