Stereotactic Radiotherapy; Evoximab (AK112); New Adjuvant Therapy for Non-small Cell Lung CancerPhase 2NCT06391008
Immunosensitized Radiotherapy Combined With Evoximab (AK112) and Chemotherapy Neoadjuvant Therapy for Stage II-III Non-small Cell Lung Cancer
A Phase 2 study testing Stereotactic radiotherapy, Evoximab and Pemetrexed in people with Stereotactic Radiotherapy; Evoximab (AK112); New Adjuvant Therapy for Non-small Cell Lung Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Trial summary
This is an open label, prospective, single center Phase II clinical study. Intended to evaluate the main pathological response rate (MPR) and safety of stereotactic immunosensitized radiotherapy combined with Evoximab (PD-1/VEGF-A bispecific antibody) and chemotherapy neoadjuvant therapy for stage II-III NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stereotactic Radiotherapy; Evoximab (AK112); New Adjuvant Therapy for Non-small Cell Lung Cancer
- What is being tested?
- Stereotactic radiotherapy, Evoximab and Pemetrexed
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2024to 30 Jun 2025
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient voluntarily joined this study and signed an informed consent form;
- ≥ 18 years old, both male and female are eligible;
- Pathologically confirmed stage II-III NSCLC (AJCC 8th)
- NSCLC confirmed by histology or cytology; No known EGFR/ALK gene mutations
- ECOG score: 0-1;
- Expected survival time ≥ 12 weeks;
Show all 11Show fewer
- The functions of important organs meet the following requirements:
- Absolute neutrophil count ≥ 1.5 × 10 ^ 9/L; Absolute lymphocyte count ≥ 0.8 × 10 ^ 9/L; Platelets ≥ 80 × 10 ^ 9/L; Hemoglobin ≥ 90g/L; Bilirubin ≤ 1.5 × ULN (within 7 days before the first medication); ALT and AST ≤ 1.5 × ULN (within 7 days before the first medication); Serum creatinine ≤ 1.5 × ULN;
- Thyroid stimulating hormone (TSH) ≤ 1 × ULN (if abnormal, FT3 and FT4 levels should be examined simultaneously, and if FT3 and FT4 levels are normal, they can be included in the study);
- Non surgical sterilization or female patients of childbearing age are required to use a medically recognized contraceptive measure (such as an intrauterine device, contraceptive pill, or condom) during the study treatment period and within 3 months after the end of the study treatment period; Non surgically sterilized female patients of childbearing age must have a negative serum or urine HCG test within 72 hours prior to enrollment in the study; And it must be non lactation period; For male patients whose partners are women of childbearing age, effective methods of contraception should be used during the trial period and within 3 months after the last treatment medication.
- Agree to provide blood samples and histological specimens. -
Who cannot join
- The patient has any active autoimmune diseases or a history of autoimmune diseases (such as but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism; the patient has vitiligo; asthma that has completely relieved in childhood and does not require any intervention in adulthood can be included; asthma that requires medical intervention with bronchodilators cannot be included);
- The patient is currently using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive effects (dosage>10mg/day prednisone or other therapeutic hormones), and continues to use them within 2 weeks prior to enrollment;
- Has experienced severe allergic reactions to other monoclonal antibodies;
- Suffering from hypertension and unable to achieve good control through antihypertensive drug treatment (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg);
- There are clinical symptoms or diseases of the heart that cannot be well controlled, such as:
- NYHA grade 2 or above heart failure; Unstable angina pectoris; Have experienced myocardial infarction within one year; Clinically significant supraventricular or ventricular arrhythmias require treatment or intervention; QTc>450ms (male); QTc>470ms (female);
Show all 15Show fewer
- Abnormal coagulation function (INR>2.0, PT>16s), with a tendency to bleed or undergoing thrombolysis or anticoagulation treatment, allowing prophylactic use of low-dose aspirin and low molecular weight heparin;
- Received previous anti-tumor immunotherapy, chemotherapy, and anti-tumor vaccine treatment (excluding adjuvant chemotherapy, if receiving adjuvant chemotherapy, disease recurrence or metastasis occurs more than 6 months after the last chemotherapy).
- The patient has active infection, unexplained fever ≥ 38.5 ° C within 7 days before medication, or baseline white blood cell count>15 × 109/L; Individuals with purulent and chronic infections, and wounds that persist and do not heal;
- Patients with bone metastases who have received palliative radiotherapy within the 4 weeks prior to participating in this study have a bone marrow area greater than 5%;
- The patient has previously received anti PD-1, anti PD-L1, and anti PD-L2 treatments;
- Individuals who are known to be allergic to the components of recombinant humanized anti-PD-1 monoclonal antibody drugs and vaccines;
- Pregnant or lactating women, or female patients who have fertility but have not taken contraceptive measures;
- Other malignant tumors (excluding basal cell or squamous cell carcinoma, superficial bladder cancer cancer, cervical carcinoma in situ or breast cancer) in the past 5 years;
- Patients participating in other clinical trials simultaneously
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Immunosensitized Radiotherapy Combined With Evoximab (AK112) and Chemotherapy Neoadjuvant Therapy for Stage II-III Non-small Cell Lung Cancer: a Single Arm, Open Label, Phase II Clinical Study
This is an open label, prospective, single center Phase II clinical study. Intended to evaluate the main pathological response rate (MPR) and safety of stereotactic immunosensitized radiotherapy combined with Evoximab (PD-1/VEGF-A bispecific antibody) and chemotherapy neoadjuvant therapy for stage II-III NSCLC. Simultaneously observe and evaluate the complete pathological response rate (pCR), R0 resection rate, and event free survival (EFS) of stage II-III NSCLC treated with stereotactic radiotherapy combined with Evoximab (PD-1/VEGF-A bispecific antibody) and chemotherapy. Exploratory analysis based on serum/tumor molecular biological markers, as well as the optimal response time and mechanism for combined response.
- Conditions
- Stereotactic Radiotherapy; Evoximab (AK112); New Adjuvant Therapy for Non-small Cell Lung Cancer
- Being tested
- Stereotactic radiotherapy, Evoximab, Pemetrexed, Albumin Paclitaxel, Carboplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic radiotherapyRadiation
Targeting primary lung lesions and irradiable mediastinal lymph nodes, stereotactic large segment radiotherapy was performed to complete the prescribed dose, PTV (planned target area): 5Gy x 3f
EvoximabDrug
Also called AK112
Evoximab (20mg/kg, Q3W)
PemetrexedDrug
Pemetrexed (500mg/m2, Q3W)
Albumin PaclitaxelDrug
Albumin Paclitaxel 260 mg/m2, Q3W
CarboplatinDrug
Carboplatin (AUC5, Q3W)
| Study group | Role | What they receive |
|---|---|---|
| SBRT+Evoximab +pemetrexed/albumin paclitaxel+carboplatin | Experimental | Radiotherapy induction sensitization stage: For the primary lung lesion and irradiable mediastinal lymph nodes, stereotactic large segment radiotherapy is performed to complete the prescribed dose, PTV (planned target area): 5Gy x 3f.
Drug combination therapy stage: Within 7 days after radiotherapy.Evoximab (20mg/kg, Q3W)+pemetrexed (500mg/m2, Q3W)/albumin paclitaxel 260 mg/m2, Q3W+carboplatin (AUC5, Q3W) Receives: Radiation: Stereotactic radiotherapy; Drug: Evoximab; Drug: Pemetrexed; Drug: Albumin Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathological Response (MPR) Rate
MPR refers to pathology where the proportion of cancer cells in excised tumors and lymph nodes is less than 10%.
Measured: Up to 6 months
Safety and tolerability
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: Up to 6 months
Secondary outcomes (2)
Pathological complete response (pCR)
Pathological complete response (pCR): defined as the absence of residual tumor cells after evaluation of the excised tumor tissue and regional lymph nodes
Measured: Up to 6 months
EFS
Event free survival (EFS): EFS is defined as the time from randomization to exclusion of surgical progression, local or distant recurrence, or death from any cause
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start30 Apr 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stereotactic Radiotherapy; Evoximab (AK112); New Adjuvant Therapy for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391008
- Sponsor's protocol ID
- SBRT-AK112-C
- Status last verified
- Apr 2024
- First submitted
- 25 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- 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 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunosensitized Radiotherapy Combined With Evoximab (AK112) and Chemotherapy Neoadjuvant Therapy for Stage II-III Non-small Cell Lung Cancer: a Single Arm, Open Label, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT06391008
- Acronym / sponsor ID
- SBRT-AK112-C
- Conditions
- Stereotactic Radiotherapy; Evoximab (AK112); New Adjuvant Therapy for Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 30 Apr 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 30 Apr 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 is an open label, prospective, single center Phase II clinical study. Intended to evaluate the main pathological response rate (MPR) and safety of stereotactic immunosensitized radiotherapy combined with Evoximab (PD-1/VEGF-A bispecific antibody) and chemotherapy neoadjuvant therapy for stage II-III NSCLC. Simultaneously observe and evaluate the complete pathological response rate (pCR), R0 resection rate, and event free survival (EFS) of stage II-III NSCLC treated with stereotactic radiotherapy combined with Evoximab (PD-1/VEGF-A bispecific antibody) and chemotherapy. Exploratory analysis based on serum/tumor molecular biological markers, as well as the optimal response time and mechanism for combined response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT+Evoximab +pemetrexed/albumin paclitaxel+carboplatin | Experimental | Radiation: Stereotactic radiotherapy, Drug: Evoximab, Drug: Pemetrexed, Drug: Albumin Paclitaxel, Drug: CarboplatinRadiotherapy induction sensitization stage: For the primary lung lesion and irradiable mediastinal lymph nodes, stereotactic large segment radiotherapy is performed to complete the prescribed dose, PTV (planned target area): 5Gy x 3f. Drug combination therapy stage: Within 7 days after radiotherapy.Evoximab (20mg/kg, Q3W)+pemetrexed (500mg/m2, Q3W)/albumin paclitaxel 260 mg/m2, Q3W+carboplatin (AUC5, Q3W) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The patient voluntarily joined this study and signed an informed consent form;
- ≥ 18 years old, both male and female are eligible;
- Pathologically confirmed stage II-III NSCLC (AJCC 8th)
- NSCLC confirmed by histology or cytology; No known EGFR/ALK gene mutations
- ECOG score: 0-1;
Key exclusion criteria (15 listed)
- The patient has any active autoimmune diseases or a history of autoimmune diseases (such as but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism; the patient has vitiligo; asthma that has completely relieved in childhood and does not require any intervention in adulthood can be included; asthma that requires medical intervention with bronchodilators cannot be included);
- The patient is currently using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive effects (dosage>10mg/day prednisone or other therapeutic hormones), and continues to use them within 2 weeks prior to enrollment;
- Has experienced severe allergic reactions to other monoclonal antibodies;
- Suffering from hypertension and unable to achieve good control through antihypertensive drug treatment (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg);
- There are clinical symptoms or diseases of the heart that cannot be well controlled, such as:
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 |
|---|---|---|
| Stereotactic radiotherapyTargeting primary lung lesions and irradiable mediastinal lymph nodes, stereotactic large segment radiotherapy was performed to complete the prescribed dose, PTV (planned target area): 5Gy x 3f | Radiation | SBRT+Evoximab +pemetrexed/albumin paclitaxel+carboplatin |
| EvoximabAlso: AK112Evoximab (20mg/kg, Q3W) | Drug | SBRT+Evoximab +pemetrexed/albumin paclitaxel+carboplatin |
| PemetrexedPemetrexed (500mg/m2, Q3W) | Drug | SBRT+Evoximab +pemetrexed/albumin paclitaxel+carboplatin |
| Albumin PaclitaxelAlbumin Paclitaxel 260 mg/m2, Q3W | Drug | SBRT+Evoximab +pemetrexed/albumin paclitaxel+carboplatin |
| CarboplatinCarboplatin (AUC5, Q3W) | Drug | SBRT+Evoximab +pemetrexed/albumin paclitaxel+carboplatin |
Primary outcome
Major Pathological Response (MPR) Rate
Time frame: Up to 6 months
MPR refers to pathology where the proportion of cancer cells in excised tumors and lymph nodes is less than 10%.
Safety and tolerability
Time frame: Up to 6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
2 secondary outcomes
Pathological complete response (pCR)
Time frame: Up to 6 months
EFS
Time frame: Up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic radiotherapy, Evoximab and Pemetrexed in people with Stereotactic Radiotherapy; Evoximab (AK112); New Adjuvant Therapy for Non-small Cell Lung Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
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 11 inclusion and 15 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 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Baorui Liu, MD,PhD (02583106666, baoruiliu@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathological Response (MPR) Rate (time frame: Up to 6 months). 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?
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 30 Apr 2024.