Non-small Cell Lung CancerPhase 2NCT06065813
Neoadjuvant Triprizumab and Radiotherapy in Operable Patients With Stage IIA-IIIA Non-small Cell Lung Cancer
A Phase 2 study testing Toripalimab, Conventional segmental radiotherapy and opreation in people with Non-small Cell Lung Cancer and Neoadjuvant Therapy, run by Northern Jiangsu People's Hospital at 1 site in China.
Trial summary
Neoadjuvant Triprizumab and Radiotherapy in Operable Patients With Stage IIA-IIIA Non-small Cell Lung Cancer Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-small Cell Lung Cancer, Neoadjuvant Therapy, Radiotherapy
- What is being tested?
- Toripalimab, Conventional segmental radiotherapy and opreation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 8 Aug 2022to 30 May 2026
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients must volunteer participating in clinical trial; patients fully understand and sign the Informed Consent Form (ICF)
- 18 ~ 70 years old, gender not limited
- Histologically confirmed resectable stage IIA-IIIA NSCLC without prior treatment
- Patients must have at least one "target" lesion" to be used to assess response on this protocol as defined by RECIST 1.1
- Agree to provide PD-L1 immune tissue sections and corresponding pathology reports for biomarker evaluation (Tumor tissue samples must be fresh or archived samples obtained within 3 months before enrollment
- Have a performance status of 0 or 1 on the ECOG Performance Scale
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- Good organ function: ANC ≥ 1500/μL; PLT ≥ 100000/μL; HB ≥ 10.0g/dL; CR ≤ 1.5 × ULN or CrCl ≥ 60 mL/min (Use Cock-Gault formula); TB ≤ 1.5 × ULN (For patients with total bilirubin levels > 1.5 × ULN, direct bilirubin is within normal limits); AST and ALT ≤ 2.5 × ULN; TSH is within normal limits. Note: If TSH is not within the normal range at baseline, if T3 and free T4 are within the normal range, then the patient can still meet the inclusion criteria. IN、RPT、APTT≤1.5×ULN
- Patients must volunteer and be able to follow research plan visits, treatment plans, laboratory tests, and other research procedures
- According to the surgeon's assessment, the total lung function can withstand the proposed lung resection
- Within 3 days before medication，the serum of fertile woman must be tested by hcg，and the result is negative. Fertile women can use high effective method for contraception in the duration of clinical trail and 180 days after last Administration
Who cannot join
- Locally advanced unresectable or metastatic disease
- Non-small small lung cancer (NSCLC) involving the upper sulcus，large cell neuroendocrine cancer (LCNEC), sarcomatoid tumor
- Patients with known EGFR mutations or ALK translocations, non-squamous carcinoma patients need to know the status of EGFR and ALK mutations
- Early NSCLC with prior systemic anticancer therapy, including experimental drug therapy
- Have a history of (non-infectious) pneumonia / interstitial lung disease requiring steroid therapy, or currently have pneumonia / interstitial lung disease requiring steroid therapy
- Known history of active tuberculosis
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- Known to have active infection requiring systemic treatment
- known or suspected autoimmune diseases or immunodeficiency, except: patients with a history of hypothyroidism who do not require hormone therapy or are receiving physiological dose hormone replacement therapy; patients with stable type 1 diabetes whose blood glucose is controlled
- Active hepatitis B or C
- Has a known history of Human Immunodeficiency Virus (HIV) .
- Received live vaccine treatment within 30 days before drug administration; but inactivated viral vaccine for seasonal influenza is allowed
- Peripheral neuropathy ≥ grade 2
- Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- Overly sensitive reaction to other monoclonal antibodies
- Have a history of severe allergies to pemetrexed, paclitaxel or docetaxel, cisplatin, carboplatin or their preventive medicine
- Known to have serious or uncontrolled underlying disease
- According to the investigator's judgment, the patient has a history or current evidence of any disease, treatment or laboratory abnormality that may confuse the test results, interfere with the participant's participation in the full trial, or not in the best interest of the participant to participate in the trial
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
People's hospital of northern jiangsu
Yangzhou, Jiangsu, 225000
Buhai Wang, MD/PhD, 18051062288, wbhself@sina.com
Buhai Wang, MD/PhD
About this study
Official title: The Efficacy and Safety of Neoadjuvant Triprizumab and Radiotherapy in Operable Patients With Stage IIB-IIIA Non-small Cell Lung Cancer
Neoadjuvant Triprizumab and Radiotherapy in Operable Patients With Stage IIA-IIIA Non-small Cell Lung Cancer
- Being tested
- Toripalimab, Conventional segmental radiotherapy, opreation
- 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.
ToripalimabDrug
Also called JS001
200 mg Toripalimab intravenously every 3 weeks 3 doses of Toripalimab before operation 14 doses of Toripalimab 30 days after operation
Conventional segmental radiotherapyRadiation
the does of radiation will be 40-45Gy. The day of the first dose of Toripalimab and the first day of radiation must be the same day.
opreationOther
The operable patients will accept radical operated in 28-42 days after the third dose of Toripalimab
| Study group | Role | What they receive |
|---|---|---|
| Toripalimab | Experimental | Not described Receives: Drug: Toripalimab; Radiation: Conventional segmental radiotherapy; Other: opreation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathologic response rates
Major pathological response rates assessed by independent center pathology
Measured: 42months
Event-free survival
The time from the beginning of enrollment to the occurrence of any events, including death, disease progression, change of chemotherapy regimen, change of chemotherapy, addition of other treatments, the occurrence of fatal or intolerant side effects and other events
Measured: 42months
Secondary outcomes (4)
Overall survival
Kaplan-Meier median estimates and curves will be used to describe OS survival functions
Measured: 42 months
Pathologic complete response (pCR) rates
Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review.
Measured: 42months
Disease-free survival
Some time until the tumor recurs or die for various reasons
Measured: 42 months
Number of Participants Experiencing Adverse Events (AEs) and serious adverse events (SAEs)
Adverse events are defined as any adverse medical events that occur in the participants taking the drugs and do not necessarily have a causal relationship with the treatment. AEs/SAEs were evaluated using NCI-CTCAE v5.0
Measured: 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start8 Aug 2022
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2026 (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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Jiangsu People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Junshi Bioscience Co., Ltd.
- Responsible party
- Principal investigator, Buhai Wang, Northern Jiangsu People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065813
- Sponsor's protocol ID
- LC-001
- Status last verified
- Sep 2023
- First submitted
- 6 Sep 2023
- Last updated
- 4 Oct 2023
- 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 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Neoadjuvant Triprizumab and Radiotherapy in Operable Patients With Stage IIB-IIIA Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06065813
- Acronym / sponsor ID
- LC-001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Collaborators
- Shanghai Junshi Bioscience Co., Ltd.
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 4 Oct 2023 (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.
Neoadjuvant Triprizumab and Radiotherapy in Operable Patients With Stage IIA-IIIA Non-small Cell Lung Cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toripalimab | Experimental | Drug: Toripalimab, Radiation: Conventional segmental radiotherapy, Other: opreation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients must volunteer participating in clinical trial; patients fully understand and sign the Informed Consent Form (ICF)
- 18 ~ 70 years old, gender not limited
- Histologically confirmed resectable stage IIA-IIIA NSCLC without prior treatment
- Patients must have at least one "target" lesion" to be used to assess response on this protocol as defined by RECIST 1.1
- Agree to provide PD-L1 immune tissue sections and corresponding pathology reports for biomarker evaluation (Tumor tissue samples must be fresh or archived samples obtained within 3 months before enrollment
Key exclusion criteria (17 listed)
- Locally advanced unresectable or metastatic disease
- Non-small small lung cancer (NSCLC) involving the upper sulcus，large cell neuroendocrine cancer (LCNEC), sarcomatoid tumor
- Patients with known EGFR mutations or ALK translocations, non-squamous carcinoma patients need to know the status of EGFR and ALK mutations
- Early NSCLC with prior systemic anticancer therapy, including experimental drug therapy
- Have a history of (non-infectious) pneumonia / interstitial lung disease requiring steroid therapy, or currently have pneumonia / interstitial lung disease requiring steroid therapy
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 |
|---|---|---|
| ToripalimabAlso: JS001200 mg Toripalimab intravenously every 3 weeks 3 doses of Toripalimab before operation 14 doses of Toripalimab 30 days after operation | Drug | Toripalimab |
| Conventional segmental radiotherapythe does of radiation will be 40-45Gy. The day of the first dose of Toripalimab and the first day of radiation must be the same day. | Radiation | Toripalimab |
| opreationThe operable patients will accept radical operated in 28-42 days after the third dose of Toripalimab | Other | Toripalimab |
Primary outcome
Major pathologic response rates
Time frame: 42months
Major pathological response rates assessed by independent center pathology
Event-free survival
Time frame: 42months
The time from the beginning of enrollment to the occurrence of any events, including death, disease progression, change of chemotherapy regimen, change of chemotherapy, addition of other treatments, the occurrence of fatal or intolerant side effects and other events
4 secondary outcomes
Overall survival
Time frame: 42 months
Pathologic complete response (pCR) rates
Time frame: 42months
Disease-free survival
Time frame: 42 months
Number of Participants Experiencing Adverse Events (AEs) and serious adverse events (SAEs)
Time frame: 42 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- 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. This study is not recruiting at the moment.
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 Toripalimab, Conventional segmental radiotherapy and opreation in people with Non-small Cell Lung Cancer and Neoadjuvant Therapy, run by Northern Jiangsu People's Hospital 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 17 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 4 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wang Buhai, doctor (18051062288, wbhself@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathologic response rates (time frame: 42months). 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 4 Oct 2023.